The recent closure of Hahnemann University Hospital, a 500-bed teaching hospital in downtown Philadelphia, Pennsylvania, offers a case study of a new form of for-profit business involvement in academic medicine —private equity investment. Though the closure of this 171-year-old institution is the result of multiple factors affecting the hospital’s financial health over decades and may not have been avoidable, the hospital’s final years in the hands of a private equity firm led to a closure process that was chaotic, uncoordinated, and fundamentally not aligned with the needs of the patients and trainees that make up the core constituents of a teaching hospital. This hospital’s story involves a concerning trend that underscores the dissonance in mission of private equity and academic medicine. In an era of competition and market consolidation, other teaching hospitals may be forced to close under similar circumstances in the future, making it vital that the medical and academic communities be aware of these discordant missions to guide policy-making efforts and ensure that the needs of patients and trainees take priority in transition planning rather than the needs of investors.

Tracing the hospital’s history, much of its financial troubles began over 20 years ago. In 1993, the Allegheny Health, Education, and Research Foundation (AHERF), a nonprofit Pittsburgh-based hospital and physician practice organization, acquired Hahnemann Medical College. Forming the MCP-Hahnemann Medical School, AHERF merged the institution with another acquisition, Medical College of Pennsylvania (MCP),¹ formerly known as the Woman’s Medical College of Pennsylvania, one of the first American medical schools devoted to exclusively training female physicians.^1,2 This was part of AHERF’s aggressive growth strategy at the time and resulted in the acquisition of 14 hospitals and more than 300 Philadelphia-area primary care physician practices by 1998. This caused about $1.3 billion of debt and over $1 million in losses per day, which led AHERF to file for bankruptcy that year,² the country’s largest nonprofit healthcare bankruptcy at the time.¹ That same year, Tenet Healthcare Corporation, a for-profit healthcare company, bought AHERF’s assets in the Philadelphia region from bankruptcy for $345 million, acquiring eight hospitals, as well as all of AHREF’s physician practices.² Ultimately, Tenet sold or closed six of the acquired hospitals by 2007, leaving just Hahnemann and St. Christopher’s Hospital for Children,³ while Drexel University, a private, nonprofit university, came forward to salvage AHERF’s educational programs, creating the Drexel University College of Medicine.² Under the ownership of Tenet, Hahnemann’s financial health declined as its patient population included a growing proportion of those utilizing Medicare, Medicaid, and charity care, which resulted in a negative operating profit margin annually for the final 14 years under Tenet.^3,4 In this setting, American Academic Health System, LLC (AAHS) stepped in to purchase Hahnemann and St. Christopher’s from Tenet and, eventually, chose to close Hahnemann.⁴

That Hahnemann found itself in the hands of a private equity firm was not surprising. Such investment firms’ acquisitions of hospitals and physician practices have become increasingly more common, with the number of these types of deals increasing by 48% and reaching a value of $42.6 billion from 2010 to 2017.⁵ While for-profit hospitals have been shown to have higher mortality⁶ and lower patient satisfaction⁷ than nonprofit hospitals, the relatively new and growing trend of private equity investment in healthcare has not been rigorously evaluated. By nature, these firms use investor capital to acquire assets with the goal of increasing their value and selling them off at a profit after about 3-7 years.⁵ Thus, healthcare services provided by private equity–owned facilities are valued and supported based on their profitability. Low-profit services, such as primary care and psychiatry, are minimized while more profitable services, such as same-day surgery, are maximized.⁵ In addition, given that for-profit hospitals tend to invest less in charity care⁸ and population health⁹ as compared with nonprofit institutions, private equity–owned hospitals likely follow suit, in contrast to the humanistic values of academic medicine. Ultimately, Hahnemann’s decades-long financial troubles set the stage for a buyout by private equity investors. But this transaction was the death knell for this teaching hospital and eventually proved to be a disadvantage for the community it served.

Purchasing Hahnemann and St Christopher’s from Tenet in early 2018 for $170 million, AAHS—an affiliate of the private equity firm, Paladin Healthcare Capital, LLC, led by investment banker Joel Freedman—entered the Philadelphia healthcare market in partnership with Chicago-based healthcare real estate private equity firm, Harrison Street Real Estate Capital, LLC.⁴ Paladin had previously invested in smaller hospitals serving underserved communities,⁴ and as it began its venture with this large teaching hospital, Paladin’s president, Barry Wolfman, stated that the company’s goal was “to return [Hahnemann] to its rightful place in the landscape of healthcare.”³ However, given the real estate firm’s involvement in the deal and the permissive tier of zoning for Hahnemann’s real estate,1⁰ there were suspicions that the purchase of the hospital was a means to acquire and develop the valuable Center City real estate rather than to serve the community.³

Within months of the hospital purchase, AAHS‘s Philadelphia venture proved difficult. Four CEOs came and went as time passed, with some holding their position for only a couple of months.1¹ About 175 of Hahnemann’s nurses, support staff, and managers were laid off in April of 2019, but the hospital finances did not improve significantly.1² As it became evident that AAHS planned to close the hospital, efforts were made to prevent the closure. Drexel University filed an unsuccessful lawsuit, claiming that it would be a violation of the academic agreement between the university and hospital.1³ Once AAHS announced plans for hospital closure, the Pennsylvania Secretary of Health, Rachel Levine, MD, wrote to AAHS leadership ordering a “cease and desist” of any action toward hospital closure.¹² Despite this, AAHS began cutting vital hospital services, including trauma and cardiothoracic surgery services, within days of the closure announcement.¹⁴ While there is a state law that a hospital cannot be closed with less than 90 days’ notice, AAHS filed for bankruptcy and shut down Hahnemann’s service to the community in about half that time.¹³ The hospital real estate was separated from the operating businesses and was excluded from the bankruptcy filing,¹⁰ which further cemented suspicions that the involved private equity firms looked to profit off the land once the hospital closed.

The immediate and long-term effects of the closure of Hahnemann University Hospital on healthcare and medical education in Philadelphia are yet to be rigorously measured and evaluated. However, the hasty closure of a large inner-city teaching hospital that served as a healthcare safety net for a largely underserved minority population with 50,000 ED visits per year⁴ is a dangerous disruption to a community. The way that the hospital was closed not only defied regulatory attempts at protecting the community but also defied the values of the healthcare workers working in the hospital. Because AAHS ceased payments to hospital vendors, medical supplies were low during the final weeks at Hahnemann, which didn’t even have enough cups on the wards to provide drinking water for patients.¹⁵ Nurses reported feeling shame as they used scissors to cut wash cloths in half to have enough to wash their patients.¹⁵ The teaching hospital’s humanistic and social capital was being liquidated quickly. Even after Hahnemann’s 570 graduate medical trainees endured the stressful and chaotic process of being displaced and fortunately taken in by other programs,¹⁶ AAHS attempted to auction off Hahnemann’s graduate medical education (GME) slots and their associated government funding to the highest bidder. While a US bankruptcy judge initially approved the sale of those GME slots to a consortium of academic institutions in the Philadelphia area,¹⁷ the Center for Medicare & Medicaid Services (CMS) has appealed that decision, which resulted in a current stay on the transaction.¹⁷ AAHS treating GME trainee positions as assets to be bought and sold is a dangerous precedent to set, especially since it attempts to bypass CMS’s existing regulated process for redistributing the slots.

While time will reveal the effects of the hospital closure, the most concerning element of this story is that the methods of a private equity firm in closing a large inner-city teaching hospital flouted attempts by regulatory agencies acting to preserve the hospital’s mission to the community. The governor of Pennsylvania, Tom Wolf (D), and mayor of Philadelphia, Jim Kenney (D), issued a joint statement chastising the actions of AAHS: “The situation at Hahnemann University Hospital, caused by CEO Joel Freedman and his team of venture capitalists, is an absolute disgrace and shows a greed-driven lack of care for the community.”1⁸ This chaotic situation inspired Philadelphia Councilperson Helen Gym (D) to propose city legislation requiring 180 days’ notice of a hospital closure, bestowing a strong local means of protecting the city’s people from similar healthcare fiascos in the future.¹⁵

At its core, healthcare is a human-to-human interaction with the purpose of improving and maintaining the health and life of the patient. Adding to that the noble efforts in educating students and trainees to provide that public good, academic medicine is a virtuous endeavor. The new and growing phenomenon of private equity in healthcare prioritizes maximizing a return on investment, so the closure of Hahnemann University Hospital in Philadelphia highlights manifestations of the discordance of the missions of private equity and academic medicine and serves as “the canary in the coal mine,” warning teaching hospitals and communities that this disconnect necessitates regulatory policies to protect academic medicine’s service to the community while private equity investment continues to spread in healthcare.

The recent closure of Hahnemann University Hospital, a 500-bed teaching hospital in downtown Philadelphia, Pennsylvania, offers a case study of a new form of for-profit business involvement in academic medicine —private equity investment. Though the closure of this 171-year-old institution is the result of multiple factors affecting the hospital’s financial health over decades and may not have been avoidable, the hospital’s final years in the hands of a private equity firm led to a closure process that was chaotic, uncoordinated, and fundamentally not aligned with the needs of the patients and trainees that make up the core constituents of a teaching hospital. This hospital’s story involves a concerning trend that underscores the dissonance in mission of private equity and academic medicine. In an era of competition and market consolidation, other teaching hospitals may be forced to close under similar circumstances in the future, making it vital that the medical and academic communities be aware of these discordant missions to guide policy-making efforts and ensure that the needs of patients and trainees take priority in transition planning rather than the needs of investors.

Tracing the hospital’s history, much of its financial troubles began over 20 years ago. In 1993, the Allegheny Health, Education, and Research Foundation (AHERF), a nonprofit Pittsburgh-based hospital and physician practice organization, acquired Hahnemann Medical College. Forming the MCP-Hahnemann Medical School, AHERF merged the institution with another acquisition, Medical College of Pennsylvania (MCP),¹ formerly known as the Woman’s Medical College of Pennsylvania, one of the first American medical schools devoted to exclusively training female physicians.^1,2 This was part of AHERF’s aggressive growth strategy at the time and resulted in the acquisition of 14 hospitals and more than 300 Philadelphia-area primary care physician practices by 1998. This caused about $1.3 billion of debt and over $1 million in losses per day, which led AHERF to file for bankruptcy that year,² the country’s largest nonprofit healthcare bankruptcy at the time.¹ That same year, Tenet Healthcare Corporation, a for-profit healthcare company, bought AHERF’s assets in the Philadelphia region from bankruptcy for $345 million, acquiring eight hospitals, as well as all of AHREF’s physician practices.² Ultimately, Tenet sold or closed six of the acquired hospitals by 2007, leaving just Hahnemann and St. Christopher’s Hospital for Children,³ while Drexel University, a private, nonprofit university, came forward to salvage AHERF’s educational programs, creating the Drexel University College of Medicine.² Under the ownership of Tenet, Hahnemann’s financial health declined as its patient population included a growing proportion of those utilizing Medicare, Medicaid, and charity care, which resulted in a negative operating profit margin annually for the final 14 years under Tenet.^3,4 In this setting, American Academic Health System, LLC (AAHS) stepped in to purchase Hahnemann and St. Christopher’s from Tenet and, eventually, chose to close Hahnemann.⁴

That Hahnemann found itself in the hands of a private equity firm was not surprising. Such investment firms’ acquisitions of hospitals and physician practices have become increasingly more common, with the number of these types of deals increasing by 48% and reaching a value of $42.6 billion from 2010 to 2017.⁵ While for-profit hospitals have been shown to have higher mortality⁶ and lower patient satisfaction⁷ than nonprofit hospitals, the relatively new and growing trend of private equity investment in healthcare has not been rigorously evaluated. By nature, these firms use investor capital to acquire assets with the goal of increasing their value and selling them off at a profit after about 3-7 years.⁵ Thus, healthcare services provided by private equity–owned facilities are valued and supported based on their profitability. Low-profit services, such as primary care and psychiatry, are minimized while more profitable services, such as same-day surgery, are maximized.⁵ In addition, given that for-profit hospitals tend to invest less in charity care⁸ and population health⁹ as compared with nonprofit institutions, private equity–owned hospitals likely follow suit, in contrast to the humanistic values of academic medicine. Ultimately, Hahnemann’s decades-long financial troubles set the stage for a buyout by private equity investors. But this transaction was the death knell for this teaching hospital and eventually proved to be a disadvantage for the community it served.

Purchasing Hahnemann and St Christopher’s from Tenet in early 2018 for $170 million, AAHS—an affiliate of the private equity firm, Paladin Healthcare Capital, LLC, led by investment banker Joel Freedman—entered the Philadelphia healthcare market in partnership with Chicago-based healthcare real estate private equity firm, Harrison Street Real Estate Capital, LLC.⁴ Paladin had previously invested in smaller hospitals serving underserved communities,⁴ and as it began its venture with this large teaching hospital, Paladin’s president, Barry Wolfman, stated that the company’s goal was “to return [Hahnemann] to its rightful place in the landscape of healthcare.”³ However, given the real estate firm’s involvement in the deal and the permissive tier of zoning for Hahnemann’s real estate,1⁰ there were suspicions that the purchase of the hospital was a means to acquire and develop the valuable Center City real estate rather than to serve the community.³

Within months of the hospital purchase, AAHS‘s Philadelphia venture proved difficult. Four CEOs came and went as time passed, with some holding their position for only a couple of months.1¹ About 175 of Hahnemann’s nurses, support staff, and managers were laid off in April of 2019, but the hospital finances did not improve significantly.1² As it became evident that AAHS planned to close the hospital, efforts were made to prevent the closure. Drexel University filed an unsuccessful lawsuit, claiming that it would be a violation of the academic agreement between the university and hospital.1³ Once AAHS announced plans for hospital closure, the Pennsylvania Secretary of Health, Rachel Levine, MD, wrote to AAHS leadership ordering a “cease and desist” of any action toward hospital closure.¹² Despite this, AAHS began cutting vital hospital services, including trauma and cardiothoracic surgery services, within days of the closure announcement.¹⁴ While there is a state law that a hospital cannot be closed with less than 90 days’ notice, AAHS filed for bankruptcy and shut down Hahnemann’s service to the community in about half that time.¹³ The hospital real estate was separated from the operating businesses and was excluded from the bankruptcy filing,¹⁰ which further cemented suspicions that the involved private equity firms looked to profit off the land once the hospital closed.

The immediate and long-term effects of the closure of Hahnemann University Hospital on healthcare and medical education in Philadelphia are yet to be rigorously measured and evaluated. However, the hasty closure of a large inner-city teaching hospital that served as a healthcare safety net for a largely underserved minority population with 50,000 ED visits per year⁴ is a dangerous disruption to a community. The way that the hospital was closed not only defied regulatory attempts at protecting the community but also defied the values of the healthcare workers working in the hospital. Because AAHS ceased payments to hospital vendors, medical supplies were low during the final weeks at Hahnemann, which didn’t even have enough cups on the wards to provide drinking water for patients.¹⁵ Nurses reported feeling shame as they used scissors to cut wash cloths in half to have enough to wash their patients.¹⁵ The teaching hospital’s humanistic and social capital was being liquidated quickly. Even after Hahnemann’s 570 graduate medical trainees endured the stressful and chaotic process of being displaced and fortunately taken in by other programs,¹⁶ AAHS attempted to auction off Hahnemann’s graduate medical education (GME) slots and their associated government funding to the highest bidder. While a US bankruptcy judge initially approved the sale of those GME slots to a consortium of academic institutions in the Philadelphia area,¹⁷ the Center for Medicare & Medicaid Services (CMS) has appealed that decision, which resulted in a current stay on the transaction.¹⁷ AAHS treating GME trainee positions as assets to be bought and sold is a dangerous precedent to set, especially since it attempts to bypass CMS’s existing regulated process for redistributing the slots.

While time will reveal the effects of the hospital closure, the most concerning element of this story is that the methods of a private equity firm in closing a large inner-city teaching hospital flouted attempts by regulatory agencies acting to preserve the hospital’s mission to the community. The governor of Pennsylvania, Tom Wolf (D), and mayor of Philadelphia, Jim Kenney (D), issued a joint statement chastising the actions of AAHS: “The situation at Hahnemann University Hospital, caused by CEO Joel Freedman and his team of venture capitalists, is an absolute disgrace and shows a greed-driven lack of care for the community.”1⁸ This chaotic situation inspired Philadelphia Councilperson Helen Gym (D) to propose city legislation requiring 180 days’ notice of a hospital closure, bestowing a strong local means of protecting the city’s people from similar healthcare fiascos in the future.¹⁵

At its core, healthcare is a human-to-human interaction with the purpose of improving and maintaining the health and life of the patient. Adding to that the noble efforts in educating students and trainees to provide that public good, academic medicine is a virtuous endeavor. The new and growing phenomenon of private equity in healthcare prioritizes maximizing a return on investment, so the closure of Hahnemann University Hospital in Philadelphia highlights manifestations of the discordance of the missions of private equity and academic medicine and serves as “the canary in the coal mine,” warning teaching hospitals and communities that this disconnect necessitates regulatory policies to protect academic medicine’s service to the community while private equity investment continues to spread in healthcare.

The recent closure of Hahnemann University Hospital, a 500-bed teaching hospital in downtown Philadelphia, Pennsylvania, offers a case study of a new form of for-profit business involvement in academic medicine —private equity investment. Though the closure of this 171-year-old institution is the result of multiple factors affecting the hospital’s financial health over decades and may not have been avoidable, the hospital’s final years in the hands of a private equity firm led to a closure process that was chaotic, uncoordinated, and fundamentally not aligned with the needs of the patients and trainees that make up the core constituents of a teaching hospital. This hospital’s story involves a concerning trend that underscores the dissonance in mission of private equity and academic medicine. In an era of competition and market consolidation, other teaching hospitals may be forced to close under similar circumstances in the future, making it vital that the medical and academic communities be aware of these discordant missions to guide policy-making efforts and ensure that the needs of patients and trainees take priority in transition planning rather than the needs of investors.

Tracing the hospital’s history, much of its financial troubles began over 20 years ago. In 1993, the Allegheny Health, Education, and Research Foundation (AHERF), a nonprofit Pittsburgh-based hospital and physician practice organization, acquired Hahnemann Medical College. Forming the MCP-Hahnemann Medical School, AHERF merged the institution with another acquisition, Medical College of Pennsylvania (MCP),¹ formerly known as the Woman’s Medical College of Pennsylvania, one of the first American medical schools devoted to exclusively training female physicians.^1,2 This was part of AHERF’s aggressive growth strategy at the time and resulted in the acquisition of 14 hospitals and more than 300 Philadelphia-area primary care physician practices by 1998. This caused about $1.3 billion of debt and over $1 million in losses per day, which led AHERF to file for bankruptcy that year,² the country’s largest nonprofit healthcare bankruptcy at the time.¹ That same year, Tenet Healthcare Corporation, a for-profit healthcare company, bought AHERF’s assets in the Philadelphia region from bankruptcy for $345 million, acquiring eight hospitals, as well as all of AHREF’s physician practices.² Ultimately, Tenet sold or closed six of the acquired hospitals by 2007, leaving just Hahnemann and St. Christopher’s Hospital for Children,³ while Drexel University, a private, nonprofit university, came forward to salvage AHERF’s educational programs, creating the Drexel University College of Medicine.² Under the ownership of Tenet, Hahnemann’s financial health declined as its patient population included a growing proportion of those utilizing Medicare, Medicaid, and charity care, which resulted in a negative operating profit margin annually for the final 14 years under Tenet.^3,4 In this setting, American Academic Health System, LLC (AAHS) stepped in to purchase Hahnemann and St. Christopher’s from Tenet and, eventually, chose to close Hahnemann.⁴

That Hahnemann found itself in the hands of a private equity firm was not surprising. Such investment firms’ acquisitions of hospitals and physician practices have become increasingly more common, with the number of these types of deals increasing by 48% and reaching a value of $42.6 billion from 2010 to 2017.⁵ While for-profit hospitals have been shown to have higher mortality⁶ and lower patient satisfaction⁷ than nonprofit hospitals, the relatively new and growing trend of private equity investment in healthcare has not been rigorously evaluated. By nature, these firms use investor capital to acquire assets with the goal of increasing their value and selling them off at a profit after about 3-7 years.⁵ Thus, healthcare services provided by private equity–owned facilities are valued and supported based on their profitability. Low-profit services, such as primary care and psychiatry, are minimized while more profitable services, such as same-day surgery, are maximized.⁵ In addition, given that for-profit hospitals tend to invest less in charity care⁸ and population health⁹ as compared with nonprofit institutions, private equity–owned hospitals likely follow suit, in contrast to the humanistic values of academic medicine. Ultimately, Hahnemann’s decades-long financial troubles set the stage for a buyout by private equity investors. But this transaction was the death knell for this teaching hospital and eventually proved to be a disadvantage for the community it served.

Purchasing Hahnemann and St Christopher’s from Tenet in early 2018 for $170 million, AAHS—an affiliate of the private equity firm, Paladin Healthcare Capital, LLC, led by investment banker Joel Freedman—entered the Philadelphia healthcare market in partnership with Chicago-based healthcare real estate private equity firm, Harrison Street Real Estate Capital, LLC.⁴ Paladin had previously invested in smaller hospitals serving underserved communities,⁴ and as it began its venture with this large teaching hospital, Paladin’s president, Barry Wolfman, stated that the company’s goal was “to return [Hahnemann] to its rightful place in the landscape of healthcare.”³ However, given the real estate firm’s involvement in the deal and the permissive tier of zoning for Hahnemann’s real estate,1⁰ there were suspicions that the purchase of the hospital was a means to acquire and develop the valuable Center City real estate rather than to serve the community.³

Within months of the hospital purchase, AAHS‘s Philadelphia venture proved difficult. Four CEOs came and went as time passed, with some holding their position for only a couple of months.1¹ About 175 of Hahnemann’s nurses, support staff, and managers were laid off in April of 2019, but the hospital finances did not improve significantly.1² As it became evident that AAHS planned to close the hospital, efforts were made to prevent the closure. Drexel University filed an unsuccessful lawsuit, claiming that it would be a violation of the academic agreement between the university and hospital.1³ Once AAHS announced plans for hospital closure, the Pennsylvania Secretary of Health, Rachel Levine, MD, wrote to AAHS leadership ordering a “cease and desist” of any action toward hospital closure.¹² Despite this, AAHS began cutting vital hospital services, including trauma and cardiothoracic surgery services, within days of the closure announcement.¹⁴ While there is a state law that a hospital cannot be closed with less than 90 days’ notice, AAHS filed for bankruptcy and shut down Hahnemann’s service to the community in about half that time.¹³ The hospital real estate was separated from the operating businesses and was excluded from the bankruptcy filing,¹⁰ which further cemented suspicions that the involved private equity firms looked to profit off the land once the hospital closed.

The immediate and long-term effects of the closure of Hahnemann University Hospital on healthcare and medical education in Philadelphia are yet to be rigorously measured and evaluated. However, the hasty closure of a large inner-city teaching hospital that served as a healthcare safety net for a largely underserved minority population with 50,000 ED visits per year⁴ is a dangerous disruption to a community. The way that the hospital was closed not only defied regulatory attempts at protecting the community but also defied the values of the healthcare workers working in the hospital. Because AAHS ceased payments to hospital vendors, medical supplies were low during the final weeks at Hahnemann, which didn’t even have enough cups on the wards to provide drinking water for patients.¹⁵ Nurses reported feeling shame as they used scissors to cut wash cloths in half to have enough to wash their patients.¹⁵ The teaching hospital’s humanistic and social capital was being liquidated quickly. Even after Hahnemann’s 570 graduate medical trainees endured the stressful and chaotic process of being displaced and fortunately taken in by other programs,¹⁶ AAHS attempted to auction off Hahnemann’s graduate medical education (GME) slots and their associated government funding to the highest bidder. While a US bankruptcy judge initially approved the sale of those GME slots to a consortium of academic institutions in the Philadelphia area,¹⁷ the Center for Medicare & Medicaid Services (CMS) has appealed that decision, which resulted in a current stay on the transaction.¹⁷ AAHS treating GME trainee positions as assets to be bought and sold is a dangerous precedent to set, especially since it attempts to bypass CMS’s existing regulated process for redistributing the slots.

While time will reveal the effects of the hospital closure, the most concerning element of this story is that the methods of a private equity firm in closing a large inner-city teaching hospital flouted attempts by regulatory agencies acting to preserve the hospital’s mission to the community. The governor of Pennsylvania, Tom Wolf (D), and mayor of Philadelphia, Jim Kenney (D), issued a joint statement chastising the actions of AAHS: “The situation at Hahnemann University Hospital, caused by CEO Joel Freedman and his team of venture capitalists, is an absolute disgrace and shows a greed-driven lack of care for the community.”1⁸ This chaotic situation inspired Philadelphia Councilperson Helen Gym (D) to propose city legislation requiring 180 days’ notice of a hospital closure, bestowing a strong local means of protecting the city’s people from similar healthcare fiascos in the future.¹⁵

At its core, healthcare is a human-to-human interaction with the purpose of improving and maintaining the health and life of the patient. Adding to that the noble efforts in educating students and trainees to provide that public good, academic medicine is a virtuous endeavor. The new and growing phenomenon of private equity in healthcare prioritizes maximizing a return on investment, so the closure of Hahnemann University Hospital in Philadelphia highlights manifestations of the discordance of the missions of private equity and academic medicine and serves as “the canary in the coal mine,” warning teaching hospitals and communities that this disconnect necessitates regulatory policies to protect academic medicine’s service to the community while private equity investment continues to spread in healthcare.

Since the last National Heart, Lung, and Blood Institute’s (NHLBI) guidelines that were released in 2007, additional evidence has emerged in several areas of asthma care.¹ To provide a concise clinical update relevant to the practice of pediatric hospital medicine, we searched PubMed for asthma publications in the last 10 years with a particular focus on articles published in the last 5 years. We used a validated pediatric search filter to identify pediatric studies, MeSH term for “Asthma,” and the following terms: “Clinical Pathways,” “Clinical Protocols,” “Dexamethasone,” and “Albuterol.” From these articles, we identified three areas of emerging evidence supporting practice change relative to the inpatient care of children with asthma, which are summarized in this brief review. This clinical practice update covers the emerging evidence supporting dexamethasone use for acute asthma exacerbations, the shift away from nebulized albuterol toward metered dose inhaler (MDI) albuterol, and the utility of asthma clinical pathways.

In the last decade, emergency departments (EDs) have increasingly prescribed dexamethasone over prednisone because it is noninferior and has a superior side-effect profile, including less vomiting.² However, the evidence for dexamethasone use in hospitalized children lagged behind ED practice change. This led to uncertainty among pediatric hospitalists regarding the most appropriate oral steroid to use, particularly for children who received dexamethasone in the ED prior to admission.³

Several studies have been published to address this gap in the literature. In 2015 Parikh et al. published a multicenter retrospective cohort study of dexamethasone vs prednisone among hospitalized children using the Pediatric Health Information Systems (PHIS) database. ⁴ The authors compared 1,166 patients who received dexamethasone only with a propensity-matched cohort of 1,284 patients receiving only prednisone/prednisolone. Outcomes included the proportion with a length of stay (LOS) greater than 3 days, all-cause readmission at 7 and 30 days, and cost of admission. A greater proportion of patients receiving prednisone/prednisolone had a LOS greater than 3 days when compared with those in the dexamethasone cohort. There were no significant differences in all cause 7- or 30-day readmission. The dexamethasone cohort had statistically significantly lower costs. The authors concluded that dexamethasone may be a viable alternative to prednisone/prednisolone for children admitted for acute asthma exacerbation not requiring admission to the pediatric intensive care unit (PICU).

In 2019, Tyler et al. published a single-center, retrospective, cohort study that used interrupted time series analysis to evaluate outcomes for inpatients with asthma before and after an ED’s protocol was changed to dexamethasone.⁵ Outcomes analyzed included LOS, hospital charges, and PICU transfer rates. The study included 1,015 subjects over a 36-month period. In the post–protocol change group, 65% of the subjects received dexamethasone only while 28% received a combination of dexamethasone and prednisone/prednisolone. The authors found no immediate significant differences in LOS, ICU transfers, or charges after the protocol change. However, they did see an overall 10% increased rate of PICU transfers in the period following the protocol change, a trend that could have been caused by difficult-to-measure differences in severity of patients before and after the protocol change. If the increase in PICU transfer rate was temporally associated with the ED protocol change, an immediate change in rate would be expected, and this was not seen. The authors speculated that dexamethasone may be inferior to prednisone for inpatients with the highest severity of asthma.

Combined with the practical benefit of dexamethasone’s shorter treatment course and decreased vomiting,² these two studies support the use of dexamethasone in the inpatient setting for patients who don’t require ICU level care. A feasibility trial to determine noninferiority of dexamethasone vs prednisone is currently enrolling, according to clinicaltrials.gov.

The 2007 NHLBI guidelines are clear that short-acting beta-2 agonists (SABA), delivered via nebulization or metered-dose inhaler (MDI) with a valved holding chamber (VHC), along with systemic steroids, should be the primary treatment in pediatric acute asthma exacerbations.¹ The guidelines caution that nebulization therapy might be needed for patients who are ineffective in using MDIs because of age, level of agitation, or severity of asthma symptoms. Specific recommendations for management in the inpatient setting are brief but note that inpatient medication administration and care should mirror ED management strategies.¹ Specific in-hospital management recommendations regarding nebulization vs MDI are not addressed.

A Cochrane Review by Cates et al. assessed pediatric and adult randomized trials comparing SABA delivery via MDI-VHC with that via nebulization.⁶ The analysis included 39 trials with a total of 729 adults and 1,897 children. Six of the included trials were conducted in an inpatient setting (207 enrolled children in these studies). The authors found that mechanism of SABA delivery did not affect ED admission rates or significantly influence other markers of treatment response (peak flow and forced expiratory volumes). In children, MDI-VHC use was associated with shorter ED length of stay, as well as a decreased frequency of common SABA side effects (ie, tachycardia and tremor). This review cites several areas in which research is needed, including MDI use in severe asthma exacerbations. This population often falls outside pediatric hospitalists’ scope of practice because these patients often require ICU-level care.

A recent systematic review of pediatric acute asthma management strategies by Castro-Rodriguez et al. found that using MDI-VHC to deliver SABA was superior to using nebulization as measured by decreased ED admission rates and ED length of stay, improved asthma clinical scores, and reduced SABA side effects.⁷ A 2016 prospective randomized trial of MDI-VHC vs nebulization in preschool-aged children presenting to an ED with asthma or virally mediated wheeze found that the SABA delivered via MDI-VHC was at least as effective as that delivered via nebulization.⁸

International asthma management guidelines more strongly recommend MDI-only treatment for pediatric patients admitted with moderate asthma.⁹ Despite this guidance, and the literature supporting transition in inpatient settings to bronchodilator administration via MDI, there are several barriers to exclusive MDI use in the inpatient setting. As mentioned by Cates et al., a recognized challenge in MDI-VHC adoption is overcoming the “nebulizer culture” in treating pediatric acute asthma symptoms.⁶ Perhaps not surprisingly, Press et al., in a retrospective secondary analysis of 25 institutions managing adults and children with acute asthma symptoms, found that 32% of all pediatric patients assessed received only nebulized SABA treatments during their hospitalization.¹⁰ Transitioning from nebulized albuterol to exclusively MDI-VHC albuterol will require significant systems changes.

Clinical pathways operationalize practice guidelines and provide guidance on the treatments, testing, and management of an illness. Use of pediatric asthma pathways has increased steadily in the past decade, with one study of over 300 hospitals finding that, between 2005 to 2015, pathway implementation increased from 27% to 86%.¹¹ This expanded use has coincided with a proliferation of publications evaluating the effects of these pathways. A systematic review examining the implementation and impact of asthma protocols identified over 100 articles published between 1986 and 2010, with the majority published after 2005.¹² The study found implementation of guidelines through an asthma pathway generally improved patient care and provider performance regardless of implementation method.

Since that review, Kaiser et al. investigated the effects of pathway implementation at 42 children’s hospitals.¹³ They used interrupted time series to determine the effect of pathway implementation on LOS. Secondary outcomes included cost, use of bronchodilators, antibiotic use, and 30-day readmissions. This study found pathway implementation was associated with an 8.8% decrease in LOS and 3% decrease in hospital costs while increasing bronchodilator administration and decreasing antibiotic exposure. To determine the factors that allowed successful implementation of asthma pathways (as determined by reduction in LOS), Kaiser et al. performed qualitative interviews of key stakeholders at high- and low-performing hospitals.¹⁴ The most successful hospitals all used rigorous data-driven quality-improvement methodologies, set shared goals with key stakeholders, integrated the pathway into their electronic medical record, allowed nurses and respiratory therapists to titrate albuterol frequency, and engaged hospital leadership to secure needed resources.

Although in each of these studies, pathway implementation led to improvements in the acute management of patients, there was no reduction in pediatric asthma readmissions at 30 days.^12,13 A meta-analysis of asthma-related quality improvement interventions also did not find an association between pathway implementation alone and decreased readmissions or ED revisits.¹⁵ The lack of improvement in these metrics may have been caused by the tendency for pathways to focus on the acute asthma management and lack of focus on chronic asthma severity. Asthma admissions are an opportunity for full evaluation of disease severity, allergen exposures, and education on medication and spacer technique. Refinement of pathways with a focus on chronic control and on transition from hospital to home may move the needle on decreasing the long-term morbidity of pediatric asthma.

Current evidence suggests pediatric hospitalists should consider transitioning from prednisolone/prednisone to dexamethasone and from nebulized albuterol delivery to MDI albuterol delivery for children admitted for acute asthma exacerbation who do not require ICU-level care. Implementing asthma clinical pathways that use rigorous quality improvement methods is an effective approach to adopt these and other evidence-based practice changes.

Disclosures

The authors have nothing to disclose.

Since the last National Heart, Lung, and Blood Institute’s (NHLBI) guidelines that were released in 2007, additional evidence has emerged in several areas of asthma care.¹ To provide a concise clinical update relevant to the practice of pediatric hospital medicine, we searched PubMed for asthma publications in the last 10 years with a particular focus on articles published in the last 5 years. We used a validated pediatric search filter to identify pediatric studies, MeSH term for “Asthma,” and the following terms: “Clinical Pathways,” “Clinical Protocols,” “Dexamethasone,” and “Albuterol.” From these articles, we identified three areas of emerging evidence supporting practice change relative to the inpatient care of children with asthma, which are summarized in this brief review. This clinical practice update covers the emerging evidence supporting dexamethasone use for acute asthma exacerbations, the shift away from nebulized albuterol toward metered dose inhaler (MDI) albuterol, and the utility of asthma clinical pathways.

In the last decade, emergency departments (EDs) have increasingly prescribed dexamethasone over prednisone because it is noninferior and has a superior side-effect profile, including less vomiting.² However, the evidence for dexamethasone use in hospitalized children lagged behind ED practice change. This led to uncertainty among pediatric hospitalists regarding the most appropriate oral steroid to use, particularly for children who received dexamethasone in the ED prior to admission.³

Several studies have been published to address this gap in the literature. In 2015 Parikh et al. published a multicenter retrospective cohort study of dexamethasone vs prednisone among hospitalized children using the Pediatric Health Information Systems (PHIS) database. ⁴ The authors compared 1,166 patients who received dexamethasone only with a propensity-matched cohort of 1,284 patients receiving only prednisone/prednisolone. Outcomes included the proportion with a length of stay (LOS) greater than 3 days, all-cause readmission at 7 and 30 days, and cost of admission. A greater proportion of patients receiving prednisone/prednisolone had a LOS greater than 3 days when compared with those in the dexamethasone cohort. There were no significant differences in all cause 7- or 30-day readmission. The dexamethasone cohort had statistically significantly lower costs. The authors concluded that dexamethasone may be a viable alternative to prednisone/prednisolone for children admitted for acute asthma exacerbation not requiring admission to the pediatric intensive care unit (PICU).

In 2019, Tyler et al. published a single-center, retrospective, cohort study that used interrupted time series analysis to evaluate outcomes for inpatients with asthma before and after an ED’s protocol was changed to dexamethasone.⁵ Outcomes analyzed included LOS, hospital charges, and PICU transfer rates. The study included 1,015 subjects over a 36-month period. In the post–protocol change group, 65% of the subjects received dexamethasone only while 28% received a combination of dexamethasone and prednisone/prednisolone. The authors found no immediate significant differences in LOS, ICU transfers, or charges after the protocol change. However, they did see an overall 10% increased rate of PICU transfers in the period following the protocol change, a trend that could have been caused by difficult-to-measure differences in severity of patients before and after the protocol change. If the increase in PICU transfer rate was temporally associated with the ED protocol change, an immediate change in rate would be expected, and this was not seen. The authors speculated that dexamethasone may be inferior to prednisone for inpatients with the highest severity of asthma.

Combined with the practical benefit of dexamethasone’s shorter treatment course and decreased vomiting,² these two studies support the use of dexamethasone in the inpatient setting for patients who don’t require ICU level care. A feasibility trial to determine noninferiority of dexamethasone vs prednisone is currently enrolling, according to clinicaltrials.gov.

The 2007 NHLBI guidelines are clear that short-acting beta-2 agonists (SABA), delivered via nebulization or metered-dose inhaler (MDI) with a valved holding chamber (VHC), along with systemic steroids, should be the primary treatment in pediatric acute asthma exacerbations.¹ The guidelines caution that nebulization therapy might be needed for patients who are ineffective in using MDIs because of age, level of agitation, or severity of asthma symptoms. Specific recommendations for management in the inpatient setting are brief but note that inpatient medication administration and care should mirror ED management strategies.¹ Specific in-hospital management recommendations regarding nebulization vs MDI are not addressed.

A Cochrane Review by Cates et al. assessed pediatric and adult randomized trials comparing SABA delivery via MDI-VHC with that via nebulization.⁶ The analysis included 39 trials with a total of 729 adults and 1,897 children. Six of the included trials were conducted in an inpatient setting (207 enrolled children in these studies). The authors found that mechanism of SABA delivery did not affect ED admission rates or significantly influence other markers of treatment response (peak flow and forced expiratory volumes). In children, MDI-VHC use was associated with shorter ED length of stay, as well as a decreased frequency of common SABA side effects (ie, tachycardia and tremor). This review cites several areas in which research is needed, including MDI use in severe asthma exacerbations. This population often falls outside pediatric hospitalists’ scope of practice because these patients often require ICU-level care.

A recent systematic review of pediatric acute asthma management strategies by Castro-Rodriguez et al. found that using MDI-VHC to deliver SABA was superior to using nebulization as measured by decreased ED admission rates and ED length of stay, improved asthma clinical scores, and reduced SABA side effects.⁷ A 2016 prospective randomized trial of MDI-VHC vs nebulization in preschool-aged children presenting to an ED with asthma or virally mediated wheeze found that the SABA delivered via MDI-VHC was at least as effective as that delivered via nebulization.⁸

International asthma management guidelines more strongly recommend MDI-only treatment for pediatric patients admitted with moderate asthma.⁹ Despite this guidance, and the literature supporting transition in inpatient settings to bronchodilator administration via MDI, there are several barriers to exclusive MDI use in the inpatient setting. As mentioned by Cates et al., a recognized challenge in MDI-VHC adoption is overcoming the “nebulizer culture” in treating pediatric acute asthma symptoms.⁶ Perhaps not surprisingly, Press et al., in a retrospective secondary analysis of 25 institutions managing adults and children with acute asthma symptoms, found that 32% of all pediatric patients assessed received only nebulized SABA treatments during their hospitalization.¹⁰ Transitioning from nebulized albuterol to exclusively MDI-VHC albuterol will require significant systems changes.

Clinical pathways operationalize practice guidelines and provide guidance on the treatments, testing, and management of an illness. Use of pediatric asthma pathways has increased steadily in the past decade, with one study of over 300 hospitals finding that, between 2005 to 2015, pathway implementation increased from 27% to 86%.¹¹ This expanded use has coincided with a proliferation of publications evaluating the effects of these pathways. A systematic review examining the implementation and impact of asthma protocols identified over 100 articles published between 1986 and 2010, with the majority published after 2005.¹² The study found implementation of guidelines through an asthma pathway generally improved patient care and provider performance regardless of implementation method.

Since that review, Kaiser et al. investigated the effects of pathway implementation at 42 children’s hospitals.¹³ They used interrupted time series to determine the effect of pathway implementation on LOS. Secondary outcomes included cost, use of bronchodilators, antibiotic use, and 30-day readmissions. This study found pathway implementation was associated with an 8.8% decrease in LOS and 3% decrease in hospital costs while increasing bronchodilator administration and decreasing antibiotic exposure. To determine the factors that allowed successful implementation of asthma pathways (as determined by reduction in LOS), Kaiser et al. performed qualitative interviews of key stakeholders at high- and low-performing hospitals.¹⁴ The most successful hospitals all used rigorous data-driven quality-improvement methodologies, set shared goals with key stakeholders, integrated the pathway into their electronic medical record, allowed nurses and respiratory therapists to titrate albuterol frequency, and engaged hospital leadership to secure needed resources.

Although in each of these studies, pathway implementation led to improvements in the acute management of patients, there was no reduction in pediatric asthma readmissions at 30 days.^12,13 A meta-analysis of asthma-related quality improvement interventions also did not find an association between pathway implementation alone and decreased readmissions or ED revisits.¹⁵ The lack of improvement in these metrics may have been caused by the tendency for pathways to focus on the acute asthma management and lack of focus on chronic asthma severity. Asthma admissions are an opportunity for full evaluation of disease severity, allergen exposures, and education on medication and spacer technique. Refinement of pathways with a focus on chronic control and on transition from hospital to home may move the needle on decreasing the long-term morbidity of pediatric asthma.

Current evidence suggests pediatric hospitalists should consider transitioning from prednisolone/prednisone to dexamethasone and from nebulized albuterol delivery to MDI albuterol delivery for children admitted for acute asthma exacerbation who do not require ICU-level care. Implementing asthma clinical pathways that use rigorous quality improvement methods is an effective approach to adopt these and other evidence-based practice changes.

Disclosures

The authors have nothing to disclose.

Since the last National Heart, Lung, and Blood Institute’s (NHLBI) guidelines that were released in 2007, additional evidence has emerged in several areas of asthma care.¹ To provide a concise clinical update relevant to the practice of pediatric hospital medicine, we searched PubMed for asthma publications in the last 10 years with a particular focus on articles published in the last 5 years. We used a validated pediatric search filter to identify pediatric studies, MeSH term for “Asthma,” and the following terms: “Clinical Pathways,” “Clinical Protocols,” “Dexamethasone,” and “Albuterol.” From these articles, we identified three areas of emerging evidence supporting practice change relative to the inpatient care of children with asthma, which are summarized in this brief review. This clinical practice update covers the emerging evidence supporting dexamethasone use for acute asthma exacerbations, the shift away from nebulized albuterol toward metered dose inhaler (MDI) albuterol, and the utility of asthma clinical pathways.

In the last decade, emergency departments (EDs) have increasingly prescribed dexamethasone over prednisone because it is noninferior and has a superior side-effect profile, including less vomiting.² However, the evidence for dexamethasone use in hospitalized children lagged behind ED practice change. This led to uncertainty among pediatric hospitalists regarding the most appropriate oral steroid to use, particularly for children who received dexamethasone in the ED prior to admission.³

Several studies have been published to address this gap in the literature. In 2015 Parikh et al. published a multicenter retrospective cohort study of dexamethasone vs prednisone among hospitalized children using the Pediatric Health Information Systems (PHIS) database. ⁴ The authors compared 1,166 patients who received dexamethasone only with a propensity-matched cohort of 1,284 patients receiving only prednisone/prednisolone. Outcomes included the proportion with a length of stay (LOS) greater than 3 days, all-cause readmission at 7 and 30 days, and cost of admission. A greater proportion of patients receiving prednisone/prednisolone had a LOS greater than 3 days when compared with those in the dexamethasone cohort. There were no significant differences in all cause 7- or 30-day readmission. The dexamethasone cohort had statistically significantly lower costs. The authors concluded that dexamethasone may be a viable alternative to prednisone/prednisolone for children admitted for acute asthma exacerbation not requiring admission to the pediatric intensive care unit (PICU).

In 2019, Tyler et al. published a single-center, retrospective, cohort study that used interrupted time series analysis to evaluate outcomes for inpatients with asthma before and after an ED’s protocol was changed to dexamethasone.⁵ Outcomes analyzed included LOS, hospital charges, and PICU transfer rates. The study included 1,015 subjects over a 36-month period. In the post–protocol change group, 65% of the subjects received dexamethasone only while 28% received a combination of dexamethasone and prednisone/prednisolone. The authors found no immediate significant differences in LOS, ICU transfers, or charges after the protocol change. However, they did see an overall 10% increased rate of PICU transfers in the period following the protocol change, a trend that could have been caused by difficult-to-measure differences in severity of patients before and after the protocol change. If the increase in PICU transfer rate was temporally associated with the ED protocol change, an immediate change in rate would be expected, and this was not seen. The authors speculated that dexamethasone may be inferior to prednisone for inpatients with the highest severity of asthma.

Combined with the practical benefit of dexamethasone’s shorter treatment course and decreased vomiting,² these two studies support the use of dexamethasone in the inpatient setting for patients who don’t require ICU level care. A feasibility trial to determine noninferiority of dexamethasone vs prednisone is currently enrolling, according to clinicaltrials.gov.

The 2007 NHLBI guidelines are clear that short-acting beta-2 agonists (SABA), delivered via nebulization or metered-dose inhaler (MDI) with a valved holding chamber (VHC), along with systemic steroids, should be the primary treatment in pediatric acute asthma exacerbations.¹ The guidelines caution that nebulization therapy might be needed for patients who are ineffective in using MDIs because of age, level of agitation, or severity of asthma symptoms. Specific recommendations for management in the inpatient setting are brief but note that inpatient medication administration and care should mirror ED management strategies.¹ Specific in-hospital management recommendations regarding nebulization vs MDI are not addressed.

A Cochrane Review by Cates et al. assessed pediatric and adult randomized trials comparing SABA delivery via MDI-VHC with that via nebulization.⁶ The analysis included 39 trials with a total of 729 adults and 1,897 children. Six of the included trials were conducted in an inpatient setting (207 enrolled children in these studies). The authors found that mechanism of SABA delivery did not affect ED admission rates or significantly influence other markers of treatment response (peak flow and forced expiratory volumes). In children, MDI-VHC use was associated with shorter ED length of stay, as well as a decreased frequency of common SABA side effects (ie, tachycardia and tremor). This review cites several areas in which research is needed, including MDI use in severe asthma exacerbations. This population often falls outside pediatric hospitalists’ scope of practice because these patients often require ICU-level care.

A recent systematic review of pediatric acute asthma management strategies by Castro-Rodriguez et al. found that using MDI-VHC to deliver SABA was superior to using nebulization as measured by decreased ED admission rates and ED length of stay, improved asthma clinical scores, and reduced SABA side effects.⁷ A 2016 prospective randomized trial of MDI-VHC vs nebulization in preschool-aged children presenting to an ED with asthma or virally mediated wheeze found that the SABA delivered via MDI-VHC was at least as effective as that delivered via nebulization.⁸

International asthma management guidelines more strongly recommend MDI-only treatment for pediatric patients admitted with moderate asthma.⁹ Despite this guidance, and the literature supporting transition in inpatient settings to bronchodilator administration via MDI, there are several barriers to exclusive MDI use in the inpatient setting. As mentioned by Cates et al., a recognized challenge in MDI-VHC adoption is overcoming the “nebulizer culture” in treating pediatric acute asthma symptoms.⁶ Perhaps not surprisingly, Press et al., in a retrospective secondary analysis of 25 institutions managing adults and children with acute asthma symptoms, found that 32% of all pediatric patients assessed received only nebulized SABA treatments during their hospitalization.¹⁰ Transitioning from nebulized albuterol to exclusively MDI-VHC albuterol will require significant systems changes.

Clinical pathways operationalize practice guidelines and provide guidance on the treatments, testing, and management of an illness. Use of pediatric asthma pathways has increased steadily in the past decade, with one study of over 300 hospitals finding that, between 2005 to 2015, pathway implementation increased from 27% to 86%.¹¹ This expanded use has coincided with a proliferation of publications evaluating the effects of these pathways. A systematic review examining the implementation and impact of asthma protocols identified over 100 articles published between 1986 and 2010, with the majority published after 2005.¹² The study found implementation of guidelines through an asthma pathway generally improved patient care and provider performance regardless of implementation method.

Since that review, Kaiser et al. investigated the effects of pathway implementation at 42 children’s hospitals.¹³ They used interrupted time series to determine the effect of pathway implementation on LOS. Secondary outcomes included cost, use of bronchodilators, antibiotic use, and 30-day readmissions. This study found pathway implementation was associated with an 8.8% decrease in LOS and 3% decrease in hospital costs while increasing bronchodilator administration and decreasing antibiotic exposure. To determine the factors that allowed successful implementation of asthma pathways (as determined by reduction in LOS), Kaiser et al. performed qualitative interviews of key stakeholders at high- and low-performing hospitals.¹⁴ The most successful hospitals all used rigorous data-driven quality-improvement methodologies, set shared goals with key stakeholders, integrated the pathway into their electronic medical record, allowed nurses and respiratory therapists to titrate albuterol frequency, and engaged hospital leadership to secure needed resources.

Although in each of these studies, pathway implementation led to improvements in the acute management of patients, there was no reduction in pediatric asthma readmissions at 30 days.^12,13 A meta-analysis of asthma-related quality improvement interventions also did not find an association between pathway implementation alone and decreased readmissions or ED revisits.¹⁵ The lack of improvement in these metrics may have been caused by the tendency for pathways to focus on the acute asthma management and lack of focus on chronic asthma severity. Asthma admissions are an opportunity for full evaluation of disease severity, allergen exposures, and education on medication and spacer technique. Refinement of pathways with a focus on chronic control and on transition from hospital to home may move the needle on decreasing the long-term morbidity of pediatric asthma.

Current evidence suggests pediatric hospitalists should consider transitioning from prednisolone/prednisone to dexamethasone and from nebulized albuterol delivery to MDI albuterol delivery for children admitted for acute asthma exacerbation who do not require ICU-level care. Implementing asthma clinical pathways that use rigorous quality improvement methods is an effective approach to adopt these and other evidence-based practice changes.

Disclosures

The authors have nothing to disclose.

Readmissions following hospitalization for exacerbations of chronic obstructive pulmonary disease (COPD) are common and economically burdensome.¹ The Affordable Care Act² outlined the Hospital Readmissions Reduction Program (HRRP),³ which aims to improve the quality of care and reduce the costs for patients with pneumonia, myocardial infarction, congestive heart failure, and COPD.³ With the implementation of the HRRP, readmission reduction has become a key priority of health systems.

Multiple approaches to reduce readmissions are published, with variable degrees of success across respiratory and all-cause rehospitalizations.⁴ Patient self-management programs are heterogenous with inconsistent utilization reductions.^5-7 While some transitional care programs demonstrate benefits,^8-10 one notable study of an intensive transitional care and self-management program showed increaseNod acute care utilization without improving health-related quality of life.^11-13 Another study of COPD comprehensive care management was stopped prematurely for increased mortality in the intervention group.¹⁴ Telehealth monitoring may predict exacerbations,^15,16 but inconsistent effects on quality of life and utilization are observed.^17,18 Pulmonary rehabilitation improves quality of life but not healthcare utilization.¹⁹ Dispensing respiratory medications at hospital discharge shows improved prescription fills and fewer readmissions,²⁰ further reinforced by inhaler training prior to discharge.²¹ Postdischarge oxygen therapy does not improve health-related quality of life or acute care utilization.²² The fact that these approaches have not reliably succeeded raises the need for further study on the drivers of readmissions in COPD. Previous studies found differences in factors associated with the timing of COPD readmissions and return diagnoses.^23,24 While HRRP is Medicare-specific, health systems likely use programs targeting their entire population when planning readmission reduction strategies. Previous analyses were primarily single-center studies²⁵ and Medicare²⁴ or private insurance claims.²⁶

In this analysis, we explore how comorbidity burden^27-29 may differentially influence readmissions for recurrent COPD exacerbations versus other diagnoses. Our approach uses a national all-payer sample that covers a diverse geographic area across the United States, providing robust estimates of factors influencing readmission and valuable insights for planning and implementing effective readmission reduction programs. By including data from a period that encompasses the implementation of HRRP, we also provide new information on the factors in the HRRP postimplementation that are not yet available in published literature.

Data Source

The Nationwide Readmissions Database (NRD) is a nationally representative, all-payer, 100% sample of community acute care hospital discharges from multiple states.³⁰ We pooled COPD discharge records spanning 2010-2016, excluding those where the patients were not residents of the state in which they were hospitalized to minimize loss to follow-up.

Inclusion/Exclusion Criteria

Selection criteria mirrored the methodology used by the HRRP,^31,32 defining an index discharge as a patient ≥40 years of age with a qualifying COPD diagnosis (Appendix Tables 1-2), discharged alive, with at least 30 days elapsed since previous hospitalization. We excluded discharges against medical advice or those from a hospital with fewer than 25 COPD discharges in that calendar year as per HRRP,^31,32 as well as those involving lung transplants. In this pooled cross-sectional analysis, record identifiers were not reliably unique across years. We restricted to observations originating February-November because January stays may not have had the requisite HRRP 30-day washout period from last admission and December stays could not be tracked into the subsequent January.

Outcomes

We defined a readmission as subsequent hospitalization for any cause within 30 days of the index discharge, with exemptions defined by the HRRP (Appendix Figure 1).^31,32 We segmented the readmission outcome into two parts: those readmitted with diagnoses that met the COPD HRRP criteria versus for any other diagnoses. We also tabulated diagnosis-related groups (DRGs) coded for the readmission observation to capture attributable cause for rehospitalization.

Our main independent variable was the Elixhauser Comorbidity Index score,³³ constructed using adaptations of published software,^34,35 having previously validated its use for modeling COPD readmissions.³⁶ We involved covariates provided with the database, including sociodemographic variables (eg, age, sex, community characteristics, payer, and median income at patient’s ZIP code) and hospital characteristics (eg, size, ownership, teaching status). We constructed additional covariates to account for in-hospital events by aggregating ICD diagnosis and procedure codes (eg, mechanical ventilation), hospital discharge volume, and proportion of annual within-hospital Medicaid patient days as a surrogate marker for safety-net hospitals. A detailed explanation of database construction and selection criteria is found in the Supplemental Methods Appendix.

Statistical Analysis

We tabulated patient-level descriptive statistics across the three outcomes of interest (ie, not readmitted, readmitted for a stay that would have qualified as COPD-related by HRRP criteria and readmitted for any other diagnosis). Continuous variables were compared using Welch’s t-tests (ie, unequal variance) and categorical variables using Chi-squared tests. At the hospital level, we tabulated the proportions of hospitals within categories in key variables of interest and a sub-population readmission rate for that particular characteristic, compared using Chi-squared tests.

We fit a multilevel multinomial logistic regression with random intercepts at the hospital cluster level, with the tripartite readmission outcome described above with “not readmitted” as the reference group. We included fixed effects for year, Elixhauser score, and patient- and hospital-level covariates as described above. Time to readmission for each group was plotted to assess the time distribution for each outcome. In-hospital mortality during each readmission event was tabulated.

Sensitivity Analyses and Missing Data

We conducted sensitivity analyses to determine whether a lower age cutoff (≥18 years) affects modeling. We also tested the stability of our estimates across each individual year of the pooled analysis. To test the effect of time to differential readmission, we fit a Cox proportional hazards model within the readmitted patient subgroup with Huber-White standard errors clustered at the hospital level to estimate the differential hazard of readmission for COPD versus non-COPD diagnoses across the same variables of interest as a sensitivity analysis. We also tested using a liberal classification of readmission diagnoses by sorting into “respiratory” versus “nonrespiratory” returns, with DRGs 163 through 208 for “respiratory” versus all others, respectively. We tested the agreement between the HRRP ICD-based classification and DRG classification using Cohen’s kappa.

We designated a threshold of 10% missing data to necessitate imputation techniques, determined a priori for our main variables, none of which met this level. Complete case analyses were used for all models. Analyses were performed in Stata version 15.1 (StataCorp, College Station, Texas) with weighted estimates reported using patient-level survey weights for national representativeness.³⁷ The study protocol was reviewed by the institutional review board at the University of California, Los Angeles, and deemed exempt from oversight due to the publicly available, deidentified nature of the data (IRB# 18-001208).

Out of 104,897,595 hospitalizations in the NRD, a final sample of 1,622,983 COPD discharges was identified for our analysis (sample weighted effective population 3,743,164). The overall readmission rate was 17.25%, with 7.69% of patients readmitted for COPD and 9.56% readmitted for other diagnoses. Those with COPD readmissions were significantly younger with a lower proportion of Medicare and a higher proportion of Medicaid as the primary payer compared with those readmitted for all other causes (Table 1). Compared with non-COPD-readmitted patients, COPD-readmitted patients were more frequently discharged home without services and had shorter lengths of stay. Noninvasive ventilation was more common among COPD readmissions while mechanical ventilation and tracheostomy placement were less frequent compared with non-COPD readmissions. Compared with non-COPD-readmitted patients, COPD-readmitted patients had significantly lower mean Elixhauser Comorbidity Index scores (17.8 vs 22.8), rates of congestive heart failure (28.3% vs 38.6%), and renal failure (11.8% vs 21.5%; Appendix Table 3).

Readmission rates were significantly higher for non-COPD causes than for COPD causes across all hospital types by ownership, teaching status, or size (Table 2). Parallel patterns were observed for non-COPD and COPD readmissions across hospital types, with two key exceptions. Across categories of hospital ownership, for-profit hospitals had the highest rates for non-COPD readmissions, with no differences in hospital control for COPD rehospitalizations. While rates did not vary for non-COPD readmissions by within-hospital Medicaid prevalence, COPD readmission rates significantly increased as Medicaid-paid patient-days increased within hospitals.

In this assessment of readmission odds following hospitalizations for COPD in a nationally representative all-payer sample, we demonstrate that 55% of rehospitalizations following COPD exacerbations are attributable to non-COPD diagnoses and describe the important role of comorbidity on influencing diagnoses at rehospitalization. These findings are consistent with a prior study of Medicare patients by Shah et al.²⁴ and expand upon the results of Jacobs et al. using a pre-HRRP sample of the NRD.²³ Our study offers an expanded analysis by including data spanning HRRP implementation, which went into effect for COPD in October 2014.³ Effect estimates were stable across all seven years of our study in sensitivity analyses, demonstrating the robustness of our findings. Our analysis also adds to the existing body of literature by assessing which factors are associated with readmissions related to ongoing COPD versus other diagnoses.

In our study, an increase in aggregated comorbidity by the Elixhauser Index was associated with a significantly higher readmission odds, with over four times the effect size for non-COPD than COPD returns. Comorbidity also moderated the effect of other factors, such as income and discharge disposition. While overall readmission rates declined across the course of the study period, the effect of comorbidity on readmission odds for both groups remained significant in annualized models. We also observed higher rates of nearly every individual Elixhauser component comorbidity in those readmitted for non-COPD causes compared with those readmitted for COPD causes. Taken together, these results underscore the need to account for comorbidities at the individual and composite levels when identifying those at highest risk for readmissions and necessitate a multidisciplinary approach to reduce risk for the multimorbid patient.

In a 2018 report, the American Thoracic Society highlighted the focus of programs on adherence to guidelines and reducing variability in COPD care as a potential pitfall in efforts to reduce COPD readmissions.³⁹ We demonstrate that a majority of patients who are readmitted return for diagnoses other than COPD. This finding further highlights that readmission reduction programs need not only focus on COPD control but on the overall management of the patient’s complex medical comorbidities. HRRP penalties are assessed for all-cause readmissions,^31,32 and attention to the entire range of diagnoses leading to return to hospital is important to reduce readmission rates and expenditures. Use of strategies such as multispecialty clinics or integrated practice units may be useful in mitigating risk in multimorbid COPD patients.

Other significant factors that deserve further investigation include the use of postacute care services, including home health and skilled nursing facilities. Both factors were associated with higher likelihood of returning for non-COPD than for COPD-related diagnoses. This finding may be collinear to some degree with comorbidity because complex patients are probably less likely to be discharged home directly. Interestingly, those discharged to a postacute care facility had substantially high odds of readmission for a non-COPD cause. Transitional care programs, including short stays in a nursing home, are often employed to mitigate the risk of adverse outcomes after discharge in sicker patients,⁴⁰ which may be insufficient based on these data.

We applied the HRRP criteria for coding a COPD-related admission to the readmission diagnoses, which is more stringent than using only a principal diagnosis or DRGs, to maintain the same standard for defining the index and readmission event. In the sensitivity analyses, we did not find significant differences in our estimates of comorbidity’s effect on outcomes using a more liberal DRG classification system.

We also used DRGs to classify the readmission causes in order to use the same grouping logic that a payer would use when determining the cause. When evaluating which DRG patients returned for following a COPD exacerbation, pneumonia or other respiratory infections make up 13.8%, which may represent the evolution of respiratory infections that provoked the original exacerbation. Heart failure comprised 9.1% of the non-COPD causes, with about one-third of our COPD cohort having known comorbid heart failure at the time of index admission, illustrating significant overlap between these two conditions. Heart failure and pneumonia are conditions of interest in the HRRP and would potentially garner their own penalties had sufficient time elapsed since a prior hospitalization. Among other causes in the top 20 return DRGs were esophagitis, gastritis, gastrointestinal bleeding, and psychoses, which may be potentially associated with the use of corticosteroids to treat a COPD exacerbation, as described in other population studies.^41,42 Lack of medication regimen data in our analysis precludes further attribution of these causes, but the potential associations are interesting and warrant additional study.

The structure of our data as pooled annual cross sections rather than a true longitudinal cohort limited us to use only 10 months (February to November) of index hospitalizations in order to stay aligned with HRRP policy inclusion criteria. As such, we may have missed some important observations during peak respiratory virus season. As in any administrative data analysis, we are limited to codes in the discharge records, which may not reflect the entire nature of a hospitalization. Administrative data are particularly problematic in identifying true COPD exacerbations, particularly with multiple comorbid cardiopulmonary conditions.^43,44 Validating coding algorithms for identifying COPD was beyond the scope of our evaluation, which purposefully used HRRP methodology. Further study thereof would be a useful endeavor, especially with transition to ICD-10, considering that previously published evaluation was limited to ICD-9.⁴⁴ Despite these limitations, we were left with a robust and representative national cohort, which is an acceptable tradeoff.

Our study highlights the importance of understanding comorbidity as a major determinant of readmissions following COPD exacerbations, particularly in distinguishing which patients will return for COPD versus non-COPD-related diagnoses. At the health system level, readmission programs should be designed with the multimorbid patient in mind. Engagement of care teams, facilitating communication, and shared decision making are strategies to mitigate readmission risk in addition to COPD-focused disease management.³⁹ These data highlight the need to use risk prediction tools in assigning resources to reduce readmissions,⁴⁵ as well as the need to move readmission reduction programs beyond COPD management alone. Developing such systems to prospectively identify which patients are at risk of returning for both COPD and non-COPD reasons may further elucidate readmission mitigation strategies and should be a subject of future prospective study.

Acknowledgments

Data were made available through the Agency for Healthcare Research and Quality’s Healthcare Utilization Project. A full list of partner organizations providing data for the Nationwide Readmission Database can be found at https://www.hcup-us.ahrq.gov/db/hcupdatapartners.jsp.

Prior Presentation

Portions of this work were presented in abstract form at the 2018 American Thoracic Society International Conference (May 2018, San Diego, CA). This manuscript is derived from the doctoral dissertation for the degree of PhD in Health Policy and Management of the corresponding author, conferred in June 2019.

Disclaimer

This article does not necessarily represent the views and policies of the Department of Veterans Affairs or the USPSTF.

Readmissions following hospitalization for exacerbations of chronic obstructive pulmonary disease (COPD) are common and economically burdensome.¹ The Affordable Care Act² outlined the Hospital Readmissions Reduction Program (HRRP),³ which aims to improve the quality of care and reduce the costs for patients with pneumonia, myocardial infarction, congestive heart failure, and COPD.³ With the implementation of the HRRP, readmission reduction has become a key priority of health systems.

Multiple approaches to reduce readmissions are published, with variable degrees of success across respiratory and all-cause rehospitalizations.⁴ Patient self-management programs are heterogenous with inconsistent utilization reductions.^5-7 While some transitional care programs demonstrate benefits,^8-10 one notable study of an intensive transitional care and self-management program showed increaseNod acute care utilization without improving health-related quality of life.^11-13 Another study of COPD comprehensive care management was stopped prematurely for increased mortality in the intervention group.¹⁴ Telehealth monitoring may predict exacerbations,^15,16 but inconsistent effects on quality of life and utilization are observed.^17,18 Pulmonary rehabilitation improves quality of life but not healthcare utilization.¹⁹ Dispensing respiratory medications at hospital discharge shows improved prescription fills and fewer readmissions,²⁰ further reinforced by inhaler training prior to discharge.²¹ Postdischarge oxygen therapy does not improve health-related quality of life or acute care utilization.²² The fact that these approaches have not reliably succeeded raises the need for further study on the drivers of readmissions in COPD. Previous studies found differences in factors associated with the timing of COPD readmissions and return diagnoses.^23,24 While HRRP is Medicare-specific, health systems likely use programs targeting their entire population when planning readmission reduction strategies. Previous analyses were primarily single-center studies²⁵ and Medicare²⁴ or private insurance claims.²⁶

In this analysis, we explore how comorbidity burden^27-29 may differentially influence readmissions for recurrent COPD exacerbations versus other diagnoses. Our approach uses a national all-payer sample that covers a diverse geographic area across the United States, providing robust estimates of factors influencing readmission and valuable insights for planning and implementing effective readmission reduction programs. By including data from a period that encompasses the implementation of HRRP, we also provide new information on the factors in the HRRP postimplementation that are not yet available in published literature.

Data Source

The Nationwide Readmissions Database (NRD) is a nationally representative, all-payer, 100% sample of community acute care hospital discharges from multiple states.³⁰ We pooled COPD discharge records spanning 2010-2016, excluding those where the patients were not residents of the state in which they were hospitalized to minimize loss to follow-up.

Inclusion/Exclusion Criteria

Selection criteria mirrored the methodology used by the HRRP,^31,32 defining an index discharge as a patient ≥40 years of age with a qualifying COPD diagnosis (Appendix Tables 1-2), discharged alive, with at least 30 days elapsed since previous hospitalization. We excluded discharges against medical advice or those from a hospital with fewer than 25 COPD discharges in that calendar year as per HRRP,^31,32 as well as those involving lung transplants. In this pooled cross-sectional analysis, record identifiers were not reliably unique across years. We restricted to observations originating February-November because January stays may not have had the requisite HRRP 30-day washout period from last admission and December stays could not be tracked into the subsequent January.

Outcomes

We defined a readmission as subsequent hospitalization for any cause within 30 days of the index discharge, with exemptions defined by the HRRP (Appendix Figure 1).^31,32 We segmented the readmission outcome into two parts: those readmitted with diagnoses that met the COPD HRRP criteria versus for any other diagnoses. We also tabulated diagnosis-related groups (DRGs) coded for the readmission observation to capture attributable cause for rehospitalization.

Our main independent variable was the Elixhauser Comorbidity Index score,³³ constructed using adaptations of published software,^34,35 having previously validated its use for modeling COPD readmissions.³⁶ We involved covariates provided with the database, including sociodemographic variables (eg, age, sex, community characteristics, payer, and median income at patient’s ZIP code) and hospital characteristics (eg, size, ownership, teaching status). We constructed additional covariates to account for in-hospital events by aggregating ICD diagnosis and procedure codes (eg, mechanical ventilation), hospital discharge volume, and proportion of annual within-hospital Medicaid patient days as a surrogate marker for safety-net hospitals. A detailed explanation of database construction and selection criteria is found in the Supplemental Methods Appendix.

Statistical Analysis

We tabulated patient-level descriptive statistics across the three outcomes of interest (ie, not readmitted, readmitted for a stay that would have qualified as COPD-related by HRRP criteria and readmitted for any other diagnosis). Continuous variables were compared using Welch’s t-tests (ie, unequal variance) and categorical variables using Chi-squared tests. At the hospital level, we tabulated the proportions of hospitals within categories in key variables of interest and a sub-population readmission rate for that particular characteristic, compared using Chi-squared tests.

We fit a multilevel multinomial logistic regression with random intercepts at the hospital cluster level, with the tripartite readmission outcome described above with “not readmitted” as the reference group. We included fixed effects for year, Elixhauser score, and patient- and hospital-level covariates as described above. Time to readmission for each group was plotted to assess the time distribution for each outcome. In-hospital mortality during each readmission event was tabulated.

Sensitivity Analyses and Missing Data

We conducted sensitivity analyses to determine whether a lower age cutoff (≥18 years) affects modeling. We also tested the stability of our estimates across each individual year of the pooled analysis. To test the effect of time to differential readmission, we fit a Cox proportional hazards model within the readmitted patient subgroup with Huber-White standard errors clustered at the hospital level to estimate the differential hazard of readmission for COPD versus non-COPD diagnoses across the same variables of interest as a sensitivity analysis. We also tested using a liberal classification of readmission diagnoses by sorting into “respiratory” versus “nonrespiratory” returns, with DRGs 163 through 208 for “respiratory” versus all others, respectively. We tested the agreement between the HRRP ICD-based classification and DRG classification using Cohen’s kappa.

We designated a threshold of 10% missing data to necessitate imputation techniques, determined a priori for our main variables, none of which met this level. Complete case analyses were used for all models. Analyses were performed in Stata version 15.1 (StataCorp, College Station, Texas) with weighted estimates reported using patient-level survey weights for national representativeness.³⁷ The study protocol was reviewed by the institutional review board at the University of California, Los Angeles, and deemed exempt from oversight due to the publicly available, deidentified nature of the data (IRB# 18-001208).

Out of 104,897,595 hospitalizations in the NRD, a final sample of 1,622,983 COPD discharges was identified for our analysis (sample weighted effective population 3,743,164). The overall readmission rate was 17.25%, with 7.69% of patients readmitted for COPD and 9.56% readmitted for other diagnoses. Those with COPD readmissions were significantly younger with a lower proportion of Medicare and a higher proportion of Medicaid as the primary payer compared with those readmitted for all other causes (Table 1). Compared with non-COPD-readmitted patients, COPD-readmitted patients were more frequently discharged home without services and had shorter lengths of stay. Noninvasive ventilation was more common among COPD readmissions while mechanical ventilation and tracheostomy placement were less frequent compared with non-COPD readmissions. Compared with non-COPD-readmitted patients, COPD-readmitted patients had significantly lower mean Elixhauser Comorbidity Index scores (17.8 vs 22.8), rates of congestive heart failure (28.3% vs 38.6%), and renal failure (11.8% vs 21.5%; Appendix Table 3).

Readmission rates were significantly higher for non-COPD causes than for COPD causes across all hospital types by ownership, teaching status, or size (Table 2). Parallel patterns were observed for non-COPD and COPD readmissions across hospital types, with two key exceptions. Across categories of hospital ownership, for-profit hospitals had the highest rates for non-COPD readmissions, with no differences in hospital control for COPD rehospitalizations. While rates did not vary for non-COPD readmissions by within-hospital Medicaid prevalence, COPD readmission rates significantly increased as Medicaid-paid patient-days increased within hospitals.

In this assessment of readmission odds following hospitalizations for COPD in a nationally representative all-payer sample, we demonstrate that 55% of rehospitalizations following COPD exacerbations are attributable to non-COPD diagnoses and describe the important role of comorbidity on influencing diagnoses at rehospitalization. These findings are consistent with a prior study of Medicare patients by Shah et al.²⁴ and expand upon the results of Jacobs et al. using a pre-HRRP sample of the NRD.²³ Our study offers an expanded analysis by including data spanning HRRP implementation, which went into effect for COPD in October 2014.³ Effect estimates were stable across all seven years of our study in sensitivity analyses, demonstrating the robustness of our findings. Our analysis also adds to the existing body of literature by assessing which factors are associated with readmissions related to ongoing COPD versus other diagnoses.

In our study, an increase in aggregated comorbidity by the Elixhauser Index was associated with a significantly higher readmission odds, with over four times the effect size for non-COPD than COPD returns. Comorbidity also moderated the effect of other factors, such as income and discharge disposition. While overall readmission rates declined across the course of the study period, the effect of comorbidity on readmission odds for both groups remained significant in annualized models. We also observed higher rates of nearly every individual Elixhauser component comorbidity in those readmitted for non-COPD causes compared with those readmitted for COPD causes. Taken together, these results underscore the need to account for comorbidities at the individual and composite levels when identifying those at highest risk for readmissions and necessitate a multidisciplinary approach to reduce risk for the multimorbid patient.

In a 2018 report, the American Thoracic Society highlighted the focus of programs on adherence to guidelines and reducing variability in COPD care as a potential pitfall in efforts to reduce COPD readmissions.³⁹ We demonstrate that a majority of patients who are readmitted return for diagnoses other than COPD. This finding further highlights that readmission reduction programs need not only focus on COPD control but on the overall management of the patient’s complex medical comorbidities. HRRP penalties are assessed for all-cause readmissions,^31,32 and attention to the entire range of diagnoses leading to return to hospital is important to reduce readmission rates and expenditures. Use of strategies such as multispecialty clinics or integrated practice units may be useful in mitigating risk in multimorbid COPD patients.

Other significant factors that deserve further investigation include the use of postacute care services, including home health and skilled nursing facilities. Both factors were associated with higher likelihood of returning for non-COPD than for COPD-related diagnoses. This finding may be collinear to some degree with comorbidity because complex patients are probably less likely to be discharged home directly. Interestingly, those discharged to a postacute care facility had substantially high odds of readmission for a non-COPD cause. Transitional care programs, including short stays in a nursing home, are often employed to mitigate the risk of adverse outcomes after discharge in sicker patients,⁴⁰ which may be insufficient based on these data.

We applied the HRRP criteria for coding a COPD-related admission to the readmission diagnoses, which is more stringent than using only a principal diagnosis or DRGs, to maintain the same standard for defining the index and readmission event. In the sensitivity analyses, we did not find significant differences in our estimates of comorbidity’s effect on outcomes using a more liberal DRG classification system.

We also used DRGs to classify the readmission causes in order to use the same grouping logic that a payer would use when determining the cause. When evaluating which DRG patients returned for following a COPD exacerbation, pneumonia or other respiratory infections make up 13.8%, which may represent the evolution of respiratory infections that provoked the original exacerbation. Heart failure comprised 9.1% of the non-COPD causes, with about one-third of our COPD cohort having known comorbid heart failure at the time of index admission, illustrating significant overlap between these two conditions. Heart failure and pneumonia are conditions of interest in the HRRP and would potentially garner their own penalties had sufficient time elapsed since a prior hospitalization. Among other causes in the top 20 return DRGs were esophagitis, gastritis, gastrointestinal bleeding, and psychoses, which may be potentially associated with the use of corticosteroids to treat a COPD exacerbation, as described in other population studies.^41,42 Lack of medication regimen data in our analysis precludes further attribution of these causes, but the potential associations are interesting and warrant additional study.

The structure of our data as pooled annual cross sections rather than a true longitudinal cohort limited us to use only 10 months (February to November) of index hospitalizations in order to stay aligned with HRRP policy inclusion criteria. As such, we may have missed some important observations during peak respiratory virus season. As in any administrative data analysis, we are limited to codes in the discharge records, which may not reflect the entire nature of a hospitalization. Administrative data are particularly problematic in identifying true COPD exacerbations, particularly with multiple comorbid cardiopulmonary conditions.^43,44 Validating coding algorithms for identifying COPD was beyond the scope of our evaluation, which purposefully used HRRP methodology. Further study thereof would be a useful endeavor, especially with transition to ICD-10, considering that previously published evaluation was limited to ICD-9.⁴⁴ Despite these limitations, we were left with a robust and representative national cohort, which is an acceptable tradeoff.

Our study highlights the importance of understanding comorbidity as a major determinant of readmissions following COPD exacerbations, particularly in distinguishing which patients will return for COPD versus non-COPD-related diagnoses. At the health system level, readmission programs should be designed with the multimorbid patient in mind. Engagement of care teams, facilitating communication, and shared decision making are strategies to mitigate readmission risk in addition to COPD-focused disease management.³⁹ These data highlight the need to use risk prediction tools in assigning resources to reduce readmissions,⁴⁵ as well as the need to move readmission reduction programs beyond COPD management alone. Developing such systems to prospectively identify which patients are at risk of returning for both COPD and non-COPD reasons may further elucidate readmission mitigation strategies and should be a subject of future prospective study.

Acknowledgments

Data were made available through the Agency for Healthcare Research and Quality’s Healthcare Utilization Project. A full list of partner organizations providing data for the Nationwide Readmission Database can be found at https://www.hcup-us.ahrq.gov/db/hcupdatapartners.jsp.

Prior Presentation

Portions of this work were presented in abstract form at the 2018 American Thoracic Society International Conference (May 2018, San Diego, CA). This manuscript is derived from the doctoral dissertation for the degree of PhD in Health Policy and Management of the corresponding author, conferred in June 2019.

Disclaimer

This article does not necessarily represent the views and policies of the Department of Veterans Affairs or the USPSTF.

Readmissions following hospitalization for exacerbations of chronic obstructive pulmonary disease (COPD) are common and economically burdensome.¹ The Affordable Care Act² outlined the Hospital Readmissions Reduction Program (HRRP),³ which aims to improve the quality of care and reduce the costs for patients with pneumonia, myocardial infarction, congestive heart failure, and COPD.³ With the implementation of the HRRP, readmission reduction has become a key priority of health systems.

Multiple approaches to reduce readmissions are published, with variable degrees of success across respiratory and all-cause rehospitalizations.⁴ Patient self-management programs are heterogenous with inconsistent utilization reductions.^5-7 While some transitional care programs demonstrate benefits,^8-10 one notable study of an intensive transitional care and self-management program showed increaseNod acute care utilization without improving health-related quality of life.^11-13 Another study of COPD comprehensive care management was stopped prematurely for increased mortality in the intervention group.¹⁴ Telehealth monitoring may predict exacerbations,^15,16 but inconsistent effects on quality of life and utilization are observed.^17,18 Pulmonary rehabilitation improves quality of life but not healthcare utilization.¹⁹ Dispensing respiratory medications at hospital discharge shows improved prescription fills and fewer readmissions,²⁰ further reinforced by inhaler training prior to discharge.²¹ Postdischarge oxygen therapy does not improve health-related quality of life or acute care utilization.²² The fact that these approaches have not reliably succeeded raises the need for further study on the drivers of readmissions in COPD. Previous studies found differences in factors associated with the timing of COPD readmissions and return diagnoses.^23,24 While HRRP is Medicare-specific, health systems likely use programs targeting their entire population when planning readmission reduction strategies. Previous analyses were primarily single-center studies²⁵ and Medicare²⁴ or private insurance claims.²⁶

In this analysis, we explore how comorbidity burden^27-29 may differentially influence readmissions for recurrent COPD exacerbations versus other diagnoses. Our approach uses a national all-payer sample that covers a diverse geographic area across the United States, providing robust estimates of factors influencing readmission and valuable insights for planning and implementing effective readmission reduction programs. By including data from a period that encompasses the implementation of HRRP, we also provide new information on the factors in the HRRP postimplementation that are not yet available in published literature.

Data Source

The Nationwide Readmissions Database (NRD) is a nationally representative, all-payer, 100% sample of community acute care hospital discharges from multiple states.³⁰ We pooled COPD discharge records spanning 2010-2016, excluding those where the patients were not residents of the state in which they were hospitalized to minimize loss to follow-up.

Inclusion/Exclusion Criteria

Selection criteria mirrored the methodology used by the HRRP,^31,32 defining an index discharge as a patient ≥40 years of age with a qualifying COPD diagnosis (Appendix Tables 1-2), discharged alive, with at least 30 days elapsed since previous hospitalization. We excluded discharges against medical advice or those from a hospital with fewer than 25 COPD discharges in that calendar year as per HRRP,^31,32 as well as those involving lung transplants. In this pooled cross-sectional analysis, record identifiers were not reliably unique across years. We restricted to observations originating February-November because January stays may not have had the requisite HRRP 30-day washout period from last admission and December stays could not be tracked into the subsequent January.

Outcomes

We defined a readmission as subsequent hospitalization for any cause within 30 days of the index discharge, with exemptions defined by the HRRP (Appendix Figure 1).^31,32 We segmented the readmission outcome into two parts: those readmitted with diagnoses that met the COPD HRRP criteria versus for any other diagnoses. We also tabulated diagnosis-related groups (DRGs) coded for the readmission observation to capture attributable cause for rehospitalization.

Our main independent variable was the Elixhauser Comorbidity Index score,³³ constructed using adaptations of published software,^34,35 having previously validated its use for modeling COPD readmissions.³⁶ We involved covariates provided with the database, including sociodemographic variables (eg, age, sex, community characteristics, payer, and median income at patient’s ZIP code) and hospital characteristics (eg, size, ownership, teaching status). We constructed additional covariates to account for in-hospital events by aggregating ICD diagnosis and procedure codes (eg, mechanical ventilation), hospital discharge volume, and proportion of annual within-hospital Medicaid patient days as a surrogate marker for safety-net hospitals. A detailed explanation of database construction and selection criteria is found in the Supplemental Methods Appendix.

Statistical Analysis

We tabulated patient-level descriptive statistics across the three outcomes of interest (ie, not readmitted, readmitted for a stay that would have qualified as COPD-related by HRRP criteria and readmitted for any other diagnosis). Continuous variables were compared using Welch’s t-tests (ie, unequal variance) and categorical variables using Chi-squared tests. At the hospital level, we tabulated the proportions of hospitals within categories in key variables of interest and a sub-population readmission rate for that particular characteristic, compared using Chi-squared tests.

We fit a multilevel multinomial logistic regression with random intercepts at the hospital cluster level, with the tripartite readmission outcome described above with “not readmitted” as the reference group. We included fixed effects for year, Elixhauser score, and patient- and hospital-level covariates as described above. Time to readmission for each group was plotted to assess the time distribution for each outcome. In-hospital mortality during each readmission event was tabulated.

Sensitivity Analyses and Missing Data

We conducted sensitivity analyses to determine whether a lower age cutoff (≥18 years) affects modeling. We also tested the stability of our estimates across each individual year of the pooled analysis. To test the effect of time to differential readmission, we fit a Cox proportional hazards model within the readmitted patient subgroup with Huber-White standard errors clustered at the hospital level to estimate the differential hazard of readmission for COPD versus non-COPD diagnoses across the same variables of interest as a sensitivity analysis. We also tested using a liberal classification of readmission diagnoses by sorting into “respiratory” versus “nonrespiratory” returns, with DRGs 163 through 208 for “respiratory” versus all others, respectively. We tested the agreement between the HRRP ICD-based classification and DRG classification using Cohen’s kappa.

We designated a threshold of 10% missing data to necessitate imputation techniques, determined a priori for our main variables, none of which met this level. Complete case analyses were used for all models. Analyses were performed in Stata version 15.1 (StataCorp, College Station, Texas) with weighted estimates reported using patient-level survey weights for national representativeness.³⁷ The study protocol was reviewed by the institutional review board at the University of California, Los Angeles, and deemed exempt from oversight due to the publicly available, deidentified nature of the data (IRB# 18-001208).

Out of 104,897,595 hospitalizations in the NRD, a final sample of 1,622,983 COPD discharges was identified for our analysis (sample weighted effective population 3,743,164). The overall readmission rate was 17.25%, with 7.69% of patients readmitted for COPD and 9.56% readmitted for other diagnoses. Those with COPD readmissions were significantly younger with a lower proportion of Medicare and a higher proportion of Medicaid as the primary payer compared with those readmitted for all other causes (Table 1). Compared with non-COPD-readmitted patients, COPD-readmitted patients were more frequently discharged home without services and had shorter lengths of stay. Noninvasive ventilation was more common among COPD readmissions while mechanical ventilation and tracheostomy placement were less frequent compared with non-COPD readmissions. Compared with non-COPD-readmitted patients, COPD-readmitted patients had significantly lower mean Elixhauser Comorbidity Index scores (17.8 vs 22.8), rates of congestive heart failure (28.3% vs 38.6%), and renal failure (11.8% vs 21.5%; Appendix Table 3).

Readmission rates were significantly higher for non-COPD causes than for COPD causes across all hospital types by ownership, teaching status, or size (Table 2). Parallel patterns were observed for non-COPD and COPD readmissions across hospital types, with two key exceptions. Across categories of hospital ownership, for-profit hospitals had the highest rates for non-COPD readmissions, with no differences in hospital control for COPD rehospitalizations. While rates did not vary for non-COPD readmissions by within-hospital Medicaid prevalence, COPD readmission rates significantly increased as Medicaid-paid patient-days increased within hospitals.

In this assessment of readmission odds following hospitalizations for COPD in a nationally representative all-payer sample, we demonstrate that 55% of rehospitalizations following COPD exacerbations are attributable to non-COPD diagnoses and describe the important role of comorbidity on influencing diagnoses at rehospitalization. These findings are consistent with a prior study of Medicare patients by Shah et al.²⁴ and expand upon the results of Jacobs et al. using a pre-HRRP sample of the NRD.²³ Our study offers an expanded analysis by including data spanning HRRP implementation, which went into effect for COPD in October 2014.³ Effect estimates were stable across all seven years of our study in sensitivity analyses, demonstrating the robustness of our findings. Our analysis also adds to the existing body of literature by assessing which factors are associated with readmissions related to ongoing COPD versus other diagnoses.

In our study, an increase in aggregated comorbidity by the Elixhauser Index was associated with a significantly higher readmission odds, with over four times the effect size for non-COPD than COPD returns. Comorbidity also moderated the effect of other factors, such as income and discharge disposition. While overall readmission rates declined across the course of the study period, the effect of comorbidity on readmission odds for both groups remained significant in annualized models. We also observed higher rates of nearly every individual Elixhauser component comorbidity in those readmitted for non-COPD causes compared with those readmitted for COPD causes. Taken together, these results underscore the need to account for comorbidities at the individual and composite levels when identifying those at highest risk for readmissions and necessitate a multidisciplinary approach to reduce risk for the multimorbid patient.

In a 2018 report, the American Thoracic Society highlighted the focus of programs on adherence to guidelines and reducing variability in COPD care as a potential pitfall in efforts to reduce COPD readmissions.³⁹ We demonstrate that a majority of patients who are readmitted return for diagnoses other than COPD. This finding further highlights that readmission reduction programs need not only focus on COPD control but on the overall management of the patient’s complex medical comorbidities. HRRP penalties are assessed for all-cause readmissions,^31,32 and attention to the entire range of diagnoses leading to return to hospital is important to reduce readmission rates and expenditures. Use of strategies such as multispecialty clinics or integrated practice units may be useful in mitigating risk in multimorbid COPD patients.

Other significant factors that deserve further investigation include the use of postacute care services, including home health and skilled nursing facilities. Both factors were associated with higher likelihood of returning for non-COPD than for COPD-related diagnoses. This finding may be collinear to some degree with comorbidity because complex patients are probably less likely to be discharged home directly. Interestingly, those discharged to a postacute care facility had substantially high odds of readmission for a non-COPD cause. Transitional care programs, including short stays in a nursing home, are often employed to mitigate the risk of adverse outcomes after discharge in sicker patients,⁴⁰ which may be insufficient based on these data.

We applied the HRRP criteria for coding a COPD-related admission to the readmission diagnoses, which is more stringent than using only a principal diagnosis or DRGs, to maintain the same standard for defining the index and readmission event. In the sensitivity analyses, we did not find significant differences in our estimates of comorbidity’s effect on outcomes using a more liberal DRG classification system.

We also used DRGs to classify the readmission causes in order to use the same grouping logic that a payer would use when determining the cause. When evaluating which DRG patients returned for following a COPD exacerbation, pneumonia or other respiratory infections make up 13.8%, which may represent the evolution of respiratory infections that provoked the original exacerbation. Heart failure comprised 9.1% of the non-COPD causes, with about one-third of our COPD cohort having known comorbid heart failure at the time of index admission, illustrating significant overlap between these two conditions. Heart failure and pneumonia are conditions of interest in the HRRP and would potentially garner their own penalties had sufficient time elapsed since a prior hospitalization. Among other causes in the top 20 return DRGs were esophagitis, gastritis, gastrointestinal bleeding, and psychoses, which may be potentially associated with the use of corticosteroids to treat a COPD exacerbation, as described in other population studies.^41,42 Lack of medication regimen data in our analysis precludes further attribution of these causes, but the potential associations are interesting and warrant additional study.

The structure of our data as pooled annual cross sections rather than a true longitudinal cohort limited us to use only 10 months (February to November) of index hospitalizations in order to stay aligned with HRRP policy inclusion criteria. As such, we may have missed some important observations during peak respiratory virus season. As in any administrative data analysis, we are limited to codes in the discharge records, which may not reflect the entire nature of a hospitalization. Administrative data are particularly problematic in identifying true COPD exacerbations, particularly with multiple comorbid cardiopulmonary conditions.^43,44 Validating coding algorithms for identifying COPD was beyond the scope of our evaluation, which purposefully used HRRP methodology. Further study thereof would be a useful endeavor, especially with transition to ICD-10, considering that previously published evaluation was limited to ICD-9.⁴⁴ Despite these limitations, we were left with a robust and representative national cohort, which is an acceptable tradeoff.

Our study highlights the importance of understanding comorbidity as a major determinant of readmissions following COPD exacerbations, particularly in distinguishing which patients will return for COPD versus non-COPD-related diagnoses. At the health system level, readmission programs should be designed with the multimorbid patient in mind. Engagement of care teams, facilitating communication, and shared decision making are strategies to mitigate readmission risk in addition to COPD-focused disease management.³⁹ These data highlight the need to use risk prediction tools in assigning resources to reduce readmissions,⁴⁵ as well as the need to move readmission reduction programs beyond COPD management alone. Developing such systems to prospectively identify which patients are at risk of returning for both COPD and non-COPD reasons may further elucidate readmission mitigation strategies and should be a subject of future prospective study.

Acknowledgments

Data were made available through the Agency for Healthcare Research and Quality’s Healthcare Utilization Project. A full list of partner organizations providing data for the Nationwide Readmission Database can be found at https://www.hcup-us.ahrq.gov/db/hcupdatapartners.jsp.

Prior Presentation

Portions of this work were presented in abstract form at the 2018 American Thoracic Society International Conference (May 2018, San Diego, CA). This manuscript is derived from the doctoral dissertation for the degree of PhD in Health Policy and Management of the corresponding author, conferred in June 2019.

Disclaimer

This article does not necessarily represent the views and policies of the Department of Veterans Affairs or the USPSTF.

In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

In the past two decades, the incidence rate of opioid use disorder (OUD) among pregnant women has increased by more than 400%, constituting a United States public health crisis.¹ Newborns exposed to intrauterine opioids are at risk for the postnatal withdrawal syndrome known as neonatal abstinence syndrome (NAS), which requires increased hospital resources, such as neonatal intensive care unit (NICU) admission and prolonged length of stay.² Given the medical and psychosocial challenges associated with maternal OUD and NAS, a multidisciplinary, patient-centered approach to hospital care for affected newborns and their mothers is warranted. A large and growing body of research has focused on the epidemiology of NAS and approaches for its prevention, screening, and management. This review appraises updates to the literature within the past five years, with an emphasis on considerations for newborn discharge to promote optimal care for this population.

NAS is a complex disorder arising from the abrupt cessation of placental transfer of opioids after birth, although other maternal substances, including benzodiazepines and other antidepressants, have been less commonly implicated.² The term neonatal opioid withdrawal syndrome is sometimes used to indicate withdrawal from opioids specifically.³ The central and autonomic nervous systems and the gastrointestinal system (eg, tremors, increased muscle tone, high-pitched crying, feeding difficulties) are affected in NAS, with most newborns demonstrating symptoms within the first few days of life.⁴ Previously reported factors associated with NAS include opioid type, timing of exposure during pregnancy, maternal tobacco use, infant sex, and gestational age.⁵ Literature demonstrates that concurrent exposure to other prenatal substances, particularly antidepressants, benzodiazepines, and gabapentin, is significantly associated with increased risk of NAS.⁶ Recent studies also suggest that expression of NAS may relate to newborn genetic variations, particularly at the OPRM1, COMT, and CYP2B6 gene sites.^{7, 8}

State health departments have increasingly deemed NAS as a reportable diagnosis for public health surveillance, which relies on the accurate diagnosis and documentation of NAS during birth hospitalization.⁹ The diagnosis codes for NAS include the International Classification of Diseases, Ninth Revision, Clinical Modification code (ICD-9-CM) 779.5 and the International Classification of Diseases, Tenth Revision, Clinical Modification ICD-10-CM code P96.1.¹⁰ However, given the variation in the presentation and severity of NAS, no consensus has been established with regard to a standardized case definition for reporting across hospitals and states.⁹ In fact, NAS should be conceptualized as a continuum of withdrawal symptoms along which every infant with intrauterine opioid exposure resides; this continuum ranges from minor findings, which do not affect the infant’s ability to grow and develop, to severe withdrawal, resulting in excessive weight loss, dehydration, or seizures.^3,11 Ultimately, the diagnosis of NAS is made clinically based on cardinal symptoms in the setting of known or highly suspected opioid exposure. In a recent study of Tennessee Medicaid claims data, >25% of infants with a confirmed diagnosis code for NAS did not receive pharmacotherapy.¹⁰ Pharmacologic treatment of NAS, therefore, may be more appropriately considered as a marker of disease severity, rather than a requirement for diagnosis.

Although the opioid crisis and resulting rise in NAS have affected communities across the US, substantial statewide variation exists, with extremes ranging from 0.7 per 1,000 births affected by NAS in Hawaii to 33.4 per 1,000 births in West Virginia.¹² Within states, increased maternal OUD and NAS rates have also disproportionately affected rural communities possibly due to reduced access to healthcare and mental health services and poor economic conditions.¹³ A recent national study demonstrated that the proportion of newborns with NAS who were born in rural hospitals increased from 12.9% to 21.2% over the past decade; these rural newborns with NAS are more likely to be publicly insured and to require transfer after birth than newborns in urban hospitals.¹⁴ These data suggest a particular need among rural communities for increased resources targeting NAS care as well as maternal OUD prevention and treatment.

The American College of Obstetricians and Gynecologists (ACOG) recommends early universal screening for maternal substance use at the first prenatal visit with a validated screening tool; examples include the 4Ps (parents, partners, past, and pregnancy), CRAFFT (car, relax, alone, forget, friends, trouble), and the National Institute on Drug Abuse quick screen, which have all been well studied and have a high sensitivity for detecting substance use and misuse.¹⁵

Toxicology Screening

Toxicology testing for both mother and newborn is helpful in identifying or confirming intrauterine exposures, particularly in cases of polysubstance use or when a newborn manifests signs of NAS but whose mother denies opioid use. All toxicology testing should be performed with the mother’s consent, and any potential legal or mandatory ramifications of a positive test should be considered. Although universal maternal toxicology testing improves the identification of newborns at risk for NAS, this approach remains controversial; most hospitals use a risk-based approach for maternal toxicology testing.^16,17

Newborn toxicology testing can be performed from samples of hair, urine, meconium, and umbilical cord. Although frequently used, newborn urine testing has the shortest window of detection, ie, the last few days prior to delivery (Table 1). Meconium drug testing has been considered the gold standard and can detect exposures from the last 20 weeks of gestation, providing information on chronic exposures.¹⁸ In a recent survey, 10% of hospitals reported using umbilical cord toxicology as the primary method for detecting intrauterine exposures.¹⁷ This approach allows greater ease of specimen collection but may not yield results that are exactly equivalent to meconium testing.¹⁹

Close monitoring for development of NAS after birth is indicated for all newborns with confirmed or suspected intrauterine opioid exposure. Although the current American Academy of Pediatrics (AAP) guidelines recommend three days of newborn observation for exposure to short-acting opioids and five to seven days for longer acting opioids, substantial variation has been described across US hospitals in policies related to newborn length of stay for NAS observation.^{17, 20} In most hospitals, monitoring for NAS occurs in the routine postpartum unit (ie, level 1 nursery), with transfer to the NICU if pharmacologic treatment is indicated.¹⁷

The most widely used assessment tool for NAS is the Finnegan Neonatal Abstinence Scoring System (FNASS) or the modified FNASS, which assigns points for the 21 most common opioid withdrawal symptoms based on perceived severity.^{17, 21} This tool allows for assessment of symptoms, helps determine need for pharmacologic intervention, and can guide monitoring of symptoms and weaning of therapy. A commonly used score cutoff of 8 is based on prior research validating scores >8 as indicative of withdrawal symptoms as opposed to normal newborn findings.²² Despite its popularity and widespread usage, FNASS has limitations, including the need for the newborn to be stimulated or disturbed to produce an accurate assessment and scoring for nonspecific signs of withdrawal, including sneezing, yawning, and stuffiness. Recent work has attempted to simplify and shorten the FNASS to elements that are unique and specific for withdrawal.^23,24 Further research is needed to establish the validity of common scoring practices (ie, use of 8 as a cutoff) to determine the need for pharmacologic treatment.²⁵

Recent studies suggest that simple, function-based assessments, such as the Eat, Sleep, Console (ESC) approach developed by Grossman and colleagues, may serve as an alternative to the FNASS for evaluating withdrawal.^26,27 With ESC, the need for pharmacotherapy is evaluated by the newborn’s ability to (1) eat (breastfeed successfully or eat at least 1oz per feed), (2) sleep uninterrupted for at least one hour, and (3) be consoled within 10 minutes. To date, research on the implementation of ESC has primarily focused on reducing length of stay and need for pharmacologic treatment in the context of quality improvement initiatives.^26,27 Further prospective studies are warranted that compare ESC to traditional approaches involving the FNASS, and that evaluate post-discharge outcomes including newborn weight gain, ongoing withdrawal symptoms at home, and readmission.

In recent years, research increasingly supports the critical role of nonpharmacological care in management of all opioid-exposed newborns, regardless of NAS severity.^{11,27, 28} Rooming-in of mothers or caregivers has been shown to decrease the need for pharmacologic treatment, shorten the length of stay, and reduce hospital costs.^28,29 Other well-established practices include maintaining a low stimulus environment for infants with low lighting and sound, swaddling, maximizing caregiver contact with kangaroo care and skin to skin, and minimizing interventions. Therapeutic modalities, such as massage and music therapy, have been used for infants with NAS, but no evidence has supported their use. Recent studies have increasingly supported the use of acupuncture as an emerging modality in treating NAS. ³⁰

Feeding

Breastfeeding is encouraged for mothers who are stable on their methadone or buprenorphine maintenance treatment, are not using heroin or other illicit drugs, and have no other contraindications to breastfeeding, such as human immunodeficiency virus.³¹ Despite the known benefits of breastfeeding, which include decreased NAS severity, decreased need for pharmacological treatment, and shortened length of hospital stay, breastfeeding rates among mothers with OUD are low.³¹ Hospital policies that can promote maternal success in breastfeeding include tailored breastfeeding support, rooming in, and early, consistent maternal education on the benefits and safety of breastfeeding.³² A small percentage of hospitals use donor breastmilk for this population, although data on outcomes are limited.¹⁷ For formula-fed newborns, emerging research suggests that early initiation of high-calorie (22-24 kcal/ounce) formula may be beneficial to prevent excessive weight loss and poor weight gain after intrauterine opioid exposure.³³

When supportive therapy fails to adequately control symptoms of withdrawal, pharmacological management is initiated to improve infant discomfort, allow for adequate feeding and nutrition, and facilitate parental bonding (Table 2).¹¹ Opioids are the primary agent used for pharmacologic treatment, and morphine is the most commonly utilized.¹⁷ Morphine is a short-acting opioid and can be prescribed either as a weight-based weaning protocol or symptom-based regimen. Methadone is also widely used, and as a long-acting opioid, it has the advantage of twice daily dosing after the initial loading dose. Recently, buprenorphine, a partial mu opioid agonist with a long half-life, has emerged as a promising primary opioid treatment agent and has been shown to reduce the length of stay and the number of opioid treatment days compared with morphine and methadone.³⁶

When the signs and symptoms of NAS are not effectively controlled with a primary opioid or in the case of polysubstance exposure, adjunctive agents are often used, with phenobarbital and clonidine being the most common (Table 3).¹¹ Regardless of opioid agent used, multicenter quality improvement initiatives demonstrate that having a standardized weaning protocol is critical to minimizing the overall length of stay and reducing the need for adjunctive agents.^38,39 Additionally, modeling tools such as pharmacometrics for methadone and buprenorphine have shown promise in optimizing dose selection.^40,41 Modeling may include pharmacodynamic data (ie, clinical response to treatment), pharmacokinetics (ie, measures of drug distribution and clearance), and other factors, such as patient demographics, intrauterine exposure type, and symptom severity. Future studies should examine weight versus symptom-based dosing regimens as well as compare weaning schedules versus “as needed” dosing regimens.¹¹

The need for comprehensive medical and psychosocial supports for mothers with OUD cannot be overstated, given the high rates of concurrent illicit or other substance use, comorbid depression and anxiety, physical and sexual trauma, poverty and homelessness, intravenous drug use, and sex-related risk patterns.¹⁵ Significant issues of healthcare-associated stigma and criminality also affect this population. As of 2019, 23 states and the District of Columbia classify substance use during pregnancy as child abuse under civil child-welfare statutes, potentially resulting in termination of parental rights.⁴² Studies of mothers with OUD have demonstrated that they often experience guilt, shame, and fear of loss of custody, all of which can impede their trust in hospital providers and future engagement in care.⁴³ They also report frustration with and mistrust of NAS scoring assessments, which they can perceive to be disruptive and potentially biased.⁴⁴ Multiple approaches should be considered to standardize and improve the hospital experience for this population, in a way that emphasizes the mother’s role as a capable, respected participant in her newborn’s care.

Maternal Support

A coordinated, multidisciplinary approach to comprehensively support mothers with OUD should involve team members from pediatrics, neonatology, obstetrics, nursing, social work, case management, and lactation.³⁵ This support includes screening for adequate resources and a safe, supportive, drug-free home environment as well as evaluating co-occurring mental health conditions. Referrals should be provided as needed to social services, postpartum psychiatry or behavioral health services, OUD treatment and relapse-prevention programs, and harm reduction services (eg, naloxone training). In addition to the healthcare team, other community members can be enlisted to serve as a trusted, consistent, and nonjudgmental support during the hospitalization; examples may include a peer support (another mother with OUD), an OUD program caseworker, or a doula.⁴⁴

Clinical Pathways

Hospitals should establish clinical pathways for women with OUD to standardize care and communication across the continuum of care for themselves and their newborn, with input from all healthcare team members involved (prenatal, intrapartum, and postpartum).³⁵ Early, consistent information should be provided regarding expected newborn hospital course, including toxicology testing, NAS monitoring, possible NICU admission, and involvement of social work.

Provider Training

Educational opportunities in the form of continuing medical education, in-service trainings, etc., should be provided for clinical staff who care for mothers with OUD and their newborns, regarding issues of substance use, stigma, bias, and trauma-informed care.³⁵ Online training resources are available through the American Society of Addiction Medicine, the ACOG, AAP, the Centers for Disease Control and Prevention, and the Substance Abuse and Mental Health Services Administration.

Regardless of whether or not NAS is treated pharmacologically, newborns with opioid exposure may experience residual symptoms of withdrawal that persist for months.⁴ Current research suggests increased risk for morbidity, emergency department utilization, and rehospitalization after discharge in this population as well as difficulty in accessing and engaging with pediatric preventative care.^{45, 46}

A clear plan should be established upon discharge to ensure optimal newborn care and follow-up. A complete record of the newborn’s hospital stay, including maternal toxicology screenings and summary of any social work documentation, should be communicated to the primary care provider upon discharge. Close postdischarge monitoring involves addressing parenting knowledge gaps, assessing illness and injury risk, and evaluating for the presence of ongoing withdrawal symptoms.⁴ Primary care providers can also play a key role in assessing maternal stress, coping, and parenting skills as well as helping families connect to resources. Further research is warranted on how pediatric primary care systems can better build maternal trust, address parenting needs, and engage this population in routine well-child care.⁴⁷

Child Welfare, Early Intervention, and Other Services

In general, newborn safety and keeping families intact should be prioritized, with disposition into foster care only in cases of concern for child maltreatment or neglect. Under the Child Abuse Prevention and Treatment Act (CAPTA), states are required to develop Plans of Safe Care for women and newborns affected by OUD, with the goal of fostering collaboration between healthcare and social service organizations around care of these families.⁴⁸ Given the variable interpretation of Plans of Safe Care across the U.S., providers should be knowledgeable about state and local statutes and reporting requirements related to parental substance use.

As part of Plans of Safe Care, providers may be well-positioned to initiate referrals for early intervention, home visiting, and other programs designed to provide developmental or wrap-around support for families. Under Part C of the Individuals with Disabilities Education Act, many states offer early intervention on the basis of NAS as an automatic qualifying diagnosis; however, attrition of eligible families along the referral and enrollment process is substantial.⁴⁹ A standardized approach to discharging opioid-exposed newborns includes referrals to available resources and discussion of their importance with families and may increase utilization and decrease variation in care.⁵⁰

Maternal OUD presents a unique combination of medical and psychosocial challenges that affect hospital care for mothers and their newborns. Optimal care for this population warrants a multidisciplinary team of providers who are knowledgeable, collaborative, and mindful of the important role of the mother as a key participant in her newborn’s care. Despite a large and growing body of research focused on NAS prevention, screening, and treatment, ongoing efforts are needed to create hospital policies and clinical pathways that are responsive to the healthcare needs of this population, navigate sensitive issues of criminality and stigma, and ultimately support maternal parenting success.

Disclosures

The authors have no financial relationships and conflicts of interest relevant to this article to disclose.

Funding

Funding for this work was provided by Cincinnati Children’s Hospital Medical Center and Nemours/AI duPont Hospital for Children.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Urinary tract infections (UTIs) are the most common bacterial infection and one of the most common reasons for hospitalization in young infants.^1,2 The American Academy of Pediatrics (AAP) has published several clinical practice guidelines for the evaluation and management of febrile children ages 2-24 months with first-time UTIs, most recently in 2011 and affirmed in 2016.³ These guidelines do not provide recommendations for infants aged <2 months, which leads to uncertainty regarding the diagnosis and management of UTIs for infants in this age group. We assess the applicability of the AAP UTI Guideline’s action statements for infants aged <2 months presenting with first-time UTIs, with an emphasis on recent evidence. Because the considerations for bacterial infections differ for febrile infants aged <2 months compared with older infants, we do not discuss action statements one and two (determination of the likelihood of UTIs and decision to test urine) and statement seven (medical evaluation for fever after first UTI).³ Additionally, because concomitant bacteremia and meningitis are more common in this age group than in older infants, we review some of the controversies surrounding the diagnosis and treatment of these disease entities.

“Action Statement 3: To establish the diagnosis of UTI, clinicians should require both urinalysis results that suggest infection (pyuria and/or bacteriuria) and the presence of at least 50,000 colony-forming units (CFUs) per mL of a uropathogen cultured from a urine specimen obtained through catheterization or SPA.”³

To distinguish asymptomatic bacteriuria or contamination from a true UTI, the AAP Guideline requires both a positive urinalysis (UA) and culture for a diagnosis of a UTI.³ Historically, the UA was considered to be poorly sensitive for infections in young infants, with older studies reporting sensitivities ranging from 40% to 82% using urine culture as the gold standard.^4-7 Thus, infants aged <2 months with positive urine cultures and negative UAs are often treated as having true UTIs, though this practice varies by institution.⁸ Possible explanations for the low UA sensitivity in this population include rapid bladder emptying, immature immune systems, and inability to concentrate urine. However, a negative UA plus a positive urine culture could also represent a “true negative” UA and a “false positive” culture, a finding that may be more common in young infants in whom sterile urine obtainment is often challenging.

Two recent studies have addressed this issue by evaluating the UA sensitivity in patients with bacteremic UTIs, as growth of the same pathogenic organism from the blood and urine almost certainly represents true infection.^9,10 In a retrospective study of 203 infants aged <3 months with bacteremic UTIs, the presence of any leukocyte esterase (LE) or pyuria (>3 white blood cells per high-powered field [WBC/HPF]) had a sensitivity of 99.5% (95% CI: 98.5%-100%) and specificity of 93.9% (95% CI: 87.8%-93.2%).⁹ In a prospective, multicenter study of 4,147 febrile infants aged ≤60 days, of whom 27 infants had bacteremic UTIs, a positive UA (any LE, >5 WBC/HPF, or nitrite) had a sensitivity and specificity of 1.00 (95% CI: 0.87-1.00) and 0.91 (95% CI: 0.90-0.91), respectively.¹⁰ Although screening tests may appear to have higher sensitivity in more severely diseased populations (“spectrum bias”),¹¹ it is not clear that infants with bacteremic UTIs are definitively sicker than infants with nonbacteremic UTIs (see “bacteremic UTI” section below). Additionally, this study found similarly excellent sensitivity (0.94 [95% CI: 0.90-0.96]) and specificity (0.91 [95% CI: 0.90-0.91]) of the UA among infants with nonbacteremic UTIs, including infants <28 days old.¹⁰

UA sensitivity (using urine culture as the gold standard) may be lower for non-Escherichia coli UTIs.^9,10,12 In a retrospective study that included 90 infants <2 months old with UTIs, urine cultures yielding Pseudomonas aeruginosa, Enterococcus, or Klebsiella species were significantly less likely (odds ratio [95% CI]: 0.19 [0.06-0.60]; 0.14 [0.07-0.28]; 0.34 [0.17-0.68], respectively) to have pyuria (≥5 WBC/HPF) or LE (1+ or greater) than urine cultures yielding E. coli.,¹² though an alternative explanation for this finding is that these organisms may be more likely to cause asymptomatic bacteriuria or contamination.¹³

The appropriate CFU/mL threshold to define a UTI and the extent that this threshold should vary by urine collection methods are still unclear. In the aforementioned bacteremic UTI study,⁹ 12 patients with E. coli bacteremia had urine cultures with <50,000 CFU/mL plus pyuria (WBC or LE) in the UA, indicating that true UTIs may occur with <50,000 CFU/mL.

Based on these recent studies, we believe that the recommendation to incorporate UA results into the diagnoses of UTIs can be applied to infants <2 months old, as well as consideration for a UTI for colony counts of ≥10,000 CFU/mL if the UA is positive. For infants with positive urine cultures and negative UAs who have not received antibiotics, we suggest repeating both studies if treatment is being considered. For those who have started antibiotics, the pretest probability of a UTI, initial illness severity, and risks and benefits of continuing treatment should be considered.

“Action Statement 4a: When initiating treatment, the clinician should base the choice of route of administration on practical considerations. Initiating treatment orally or parenterally is equally efficacious. The clinician should base the choice of agent on local antimicrobial sensitivity patterns (if available) and should adjust the choice according to sensitivity testing of the isolated uropathogen.”³

Most infants <2 months old with UTIs are hospitalized initially because of fever. Therefore, the decision point for most clinicians is not whether to hospitalize but for how long to hospitalize and treat with intravenous (IV) antibiotics prior to discharging home on oral antibiotics. Although all-oral antibiotic regimens are used to treat UTIs in older infants and children,^14-18 to our knowledge, there are no randomized controlled trials (RCTs) comparing all-IV vs all-oral antibiotics or a longer vs shorter initial IV course that include infants <1 month old. In the trials that do include infants aged 1-2 months,^14,18 the number of subjects in this age group is too small to draw conclusions, a finding supported by a 2014 Cochrane review.¹⁹ An adequately powered RCT of different IV antibiotic durations in this age group would be challenging. For example, nearly 1,000 subjects would be needed to demonstrate a statistically significant difference between a 5% and 10% relapse risk between groups, a difference that some may find clinically important.

The paucity of evidence in this age group may explain the considerable variability in the approach to IV antibiotic duration in young infants. Concerns about enteral absorption and underdeveloped immune systems may prompt some physicians to treat the youngest patients more aggressively. One study demonstrated that the proportion of patients <2 months old receiving prolonged courses (≥4 days) of IV antibiotics for UTIs in 46 U.S. children’s hospitals ranged from 0% to 67%.²⁰ Similar variability across hospitals has been described in other observational studies^21,22 and across subspecialties in one survey of pediatricians.²³

Several observational studies provide additional evidence supporting shorter IV courses. In two studies that examined administrative databases, there was no difference in treatment failure rates between infants aged <2 months²⁰ and <6 months²¹ receiving longer (≥4 days) vs shorter IV courses. In a study of 172 infants <1 month old with UTIs, the median IV duration was 4 days (range 2-12 days), and no subjects experienced treatment failure or relapse.²⁴ In a multicenter study of 251 infants <3 months old with bacteremic UTIs, mean IV antibiotic durations ranged from 5.5–12 days, and no patient had a relapsed bacteremic UTI. Six infants (2.4%) had a relapsed UTI without bacteremia, with no association between IV antibiotic duration and relapse.²²

Based on the available data and known risks of hospitalization and prolonged IV therapy, a reasonable approach for infants <1 month old would be to hospitalize for two to three days while awaiting blood and cerebral spinal fluid (CSF) culture results. Given the possibility of Enterococcus or Enterobacteriaceae that are resistant to third-generation cephalosporins, standard therapy of ampicillin and gentamicin for febrile neonates is reasonable, assuming there is no concern for meningitis. Antibiotics should be narrowed when susceptibilities are known. Once culture results return and signs and symptoms have resolved, discharge home on oral antibiotics is justifiable based on the available literature. For well-appearing infants aged 1-2 months with a presumptive UTI (based on UA results), if hospitalization is not warranted for other reasons, then we recommend outpatient treatment with oral or intramuscular therapy based on local susceptibilities (typically a cephalosporin) and close follow-up for one to two days while awaiting culture results. Although empiric cephalosporin therapy may not provide 100% coverage for all potential organisms, clinical deterioration is uncommon in infants and children receiving discordant therapy.²⁵

“Action Statement 4b: The clinician should choose 7 to 14 days as the duration of antimicrobial therapy.”³

The AAP’s recommendation to provide antibiotics (by oral or parenteral route) for a minimum of seven days total stems from a 2002 meta-analysis comparing long (7-14 days) vs short (≤3 days) courses, where the pooled relative risk of treatment failure with short-course therapy was 1.94 (95% CI: 1.19-3.15).²⁶ However, in this analysis, the trials that demonstrated inferiority with short courses were all trials that used single doses of antibiotics, and a similar Cochrane review comparing 2-4 days with 7-14 days demonstrated no differences in outcomes.²⁷ Therefore, shorter total courses, but not a single dose, are probably appropriate for most UTIs in children. Although there are no obvious biologic reasons why longer total courses would be needed in young infants, there are unfortunately limited data comparing different total antibiotic durations in this age group. We believe that 7-14 days of total therapy is a reasonable recommendation for infants <2 months old, and that future studies should investigate shorter total courses.

“Action Statement 5: Febrile infants with UTIs should undergo renal and bladder ultrasonography (RBUS).”³

The AAP Guideline acknowledges that the RBUS is a poor screening test for the detection of genitourinary abnormalities in infants.³ The RBUS can be normal in infants with vesicoureteral reflux (VUR) or show nonspecific findings of unclear clinical significance.²⁸ In a prospective study of 220 infants <3 months old by Tsai et al, 9/39 infants (23%) with grade III-V VUR had normal RBUS.²⁹ Studies that included older infants have found a similar false-negative rate of 0%-40% for detecting grade IV-V VUR by RBUS.²⁸ Nonetheless, since a RBUS is safe and noninvasive, we feel that the benefits of screening for abnormalities such as hydronephrosis (that could indicate posterior urethral valves or ureteropelvic junction obstruction) outweigh the risks (eg, false positives, overdiagnosis, and cost) of performing a RBUS after a first-time UTI.

“Action Statement 6a: Voiding cystourethrography (VCUG) should not be performed routinely after the first febrile UTI; VCUG is indicated if RBUS reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances.”³

“Action Statement 6b: Further evaluation should be conducted if there is a recurrence of febrile UTI.”³

The RBUS may be normal in infants with VUR. Therefore, the AAP’s recommendation to perform a VCUG only if the RBUS is abnormal or after a recurrent UTI concedes that there will be infants with VUR who are missed after the first UTI.³

The United Kingdom’s National Institute for Health and Care Excellence guideline recommends a VCUG for infants <6 months old with a bacteremic or non-E. coli UTI.³⁰ Whether high-grade VUR is more common in young infants with bacteremic UTIs than nonbacteremic UTIs remains inconclusive. In the Honkinen et al. study that included 87 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR (10%) and obstruction (7%) was higher than that of the 88 nonbacteremic infants (2% grade IV-V VUR and 2% with obstruction). In the multicenter study of 251 infants <3 months old with bacteremic UTIs, the prevalence of grade IV-V VUR was 12.1%.³¹ This is higher than that of the nonbacteremic infants in Honkinen et al.’s study³² but more similar to the prevalence of grade IV-V VUR found in Tsai et al. (8.2%) and Ismaili et al.’s (7.0%) studies of UTIs in general.^29,33

There does appear to be a higher prevalence of urinary tract abnormalities in young infants with non-E. coli vs E. coli UTIs.^31,32,34,35 The odds of an abnormal VCUG was 8.0 (95% CI: 2.3-28) times higher for non-E. coli than E. coli UTIs in the study of 251 bacteremic infants.³¹ In a study of 122 infants <3 months old, the odds of grade III-V VUR was 10 (95% CI 2.6-41) times higher for non-E. coli than E. coli UTIs.³⁵

However, the need for early detection of VUR is controversial, and VCUGs are invasive, involve ionizing radiation, and may require sedation. Two recent trials (one which included only children with VUR and another in which 42% of subjects had VUR) demonstrated a modest effect of prophylactic antibiotics in preventing recurrent UTIs (>5,000 doses of antibiotics needed to prevent one UTI recurrence), but the effect size did not differ by the presence or degree of VUR, and neither demonstrated any benefit in reducing future renal scarring.^{36, 37} The benefit of surgical interventions for VUR also remains unclear, though studies are limited.³⁸ Overall, there is no evidence suggesting that infants <2 months old require more vigilance for VUR detection than the 2-24 month age group.

Bacteremic UTI

The prevalence of bacteremia in infants ≤60 days old with UTIs was 9% in a study conducted from 2008 to 2013 in 26 EDs and has ranged from 3% to 17% in older studies.^{10, 22} Many studies have described similar clinical and laboratory findings in young infants with bacteremic and nonbacteremic UTIs.^39-41 Despite this, bacteremic UTIs have been associated with prolonged parenteral antibiotic courses, resulting in longer hospitalizations and increased costs.⁴⁰ Two recent multicenter studies of infants with bacteremic UTIs (251 infants <3 months old²² and 115 infants ≤60 days old⁴²) demonstrated variable IV courses and no association between IV duration and relapsed UTI. The latter study showed no risk difference in the adjusted 30-day UTI recurrence (risk difference 3%, 95% CI: −5.8 to 12.7) or all-cause reutilization (risk difference 3%, 95% CI: −14.5 to 20.6) between long and short IV groups.⁴² Neither study had patients with relapsed bacteremic UTIs or reported that patients suffered clinical deterioration while on oral antibiotics.^22,42

Based on these data demonstrating that adverse outcomes are rare in infants with bacteremic UTIs and not associated with parenteral antibiotic duration, we recommend short parenteral courses (2-3 days) with conversion to oral therapy once infants have clinically improved.

Positive Urinalysis and Testing for Meningitis

Multiple risk stratification algorithms for febrile infants aged ≤60 days categorize infants with a positive UA (and therefore likely UTI) as high-risk for having concomitant bacteremia or meningitis, for which lumbar puncture (LP) is typically recommended.^43-45 The risk of not testing CSF is the potential to insufficiently treat meningitis because treatment for UTIs and meningitis differ in dosing, route, and duration. Recent studies have challenged the practice of routine LPs for infants aged 1-2 months with a suspected UTI due to the low prevalence (0%-0.3%) of concomitant meningitis.^39,46-48 A meta-analysis of 20 studies reporting rates of concomitant meningitis with UTI in infants aged 29-90 days found a pooled prevalence of 0.25% (95% CI: 0.09%-0.70%).⁴⁹ Furthermore, a study of febrile infants ages 29-60 days found that the prevalence of meningitis did not differ between those with a positive vs negative UA (3/337 [0.9%] vs 5/498 [1.0%], respectively), suggesting that a positive UA alone should not modify the pretest probability of meningitis in this age group.⁵⁰

Two studies have also examined the risk of delayed meningitis among infants ≤60 days old treated for UTIs without CSF testing. A northern California study that examined 345 episodes among 341 UA-positive infants aged 29-60 days found zero cases (95% CI: 0%-1.1%) of delayed meningitis within 30 days of evaluation.⁵⁰ A multicenter study of well-appearing febrile infants aged 7-60 days found 0/505 cases (95% CI: 0%-0.6%) of delayed meningitis within 7 days of discharge; 407 (81%) were aged 31-60 days.⁵¹ In summary, studies have shown a low rate of concomitant meningitis and a low risk of delayed meningitis in infants aged 1-2 months treated for UTI without CSF testing. Given this, clinically targeted (eg, based on ill appearance and/or lethargy), rather than routine, CSF testing in this age group can be considered.

While the AAP UTI Guideline is directed toward 2-24-month-old infants, recent evidence suggests that action statements 3-6 apply to infants <2 months old. Incorporation of pyuria as a diagnostic criterion for UTIs, early transition to oral therapy, and selective VCUG testing are all warranted based on the available evidence and consideration of known risks and benefits. Future studies with larger sample sizes that include infants <2 months old would be beneficial to ensure that the available studies, which have relatively small cohorts, do not suffer from type II error. We propose that future studies examine shorter (<7 days) vs longer total antibiotic duration, shorter vs longer initial IV antibiotics (especially in infants <1 month old or with bacteremic UTIs), and whether RBUS can be performed in a targeted manner. RCTs comparing universal vs targeted imaging strategies would help ascertain whether the increased diagnostic yield that accompanies more aggressive imaging strategies translates into improved outcomes. Application of these AAP guidelines to the <2-month age group and enhancement of the evidence base can promote the high-value care of young infants with UTIs.

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Challenges in conducting and completing studies of drugs in vulnerable populations, such as hospitalized children, include weak study designs and lack of sufficient sample sizes to achieve adequate power.¹ Limitations in the amount of blood that can be safely drawn in children and low parental consent rates due to concerns for anemia or pain, if venipuncture is required, lead to an insufficient number of patients enrolled in traditional clinical studies.² Thus, sample size targets are often not met. Recognizing the limited pediatric data for many drugs routinely prescribed off-label in children, the Food and Drug Administration implemented the Best Pharmaceuticals Children Act and the Pediatric Research Equity Act (PREA) in 2003; these legislative acts require clinical studies to assess the safety and efficacy of new drugs in children.¹ While studies conducted under these acts have provided important information for the clinical care of children, only one-third of mandatory pediatric postmarketing studies of the 114 new drugs and new indications subject to PREA requirements between 2007 and 2014 had been completed within seven years.³

Despite the challenges in conducting studies of drugs in children, robust pediatric data must be generated in children, especially in those with medical complexity or with chronic medical diseases and who have significant risk of experiencing adverse drug events. Data in adults cannot simply be extrapolated to children. In addition, studies from healthy children may not apply to hospitalized pediatric patients because of significant physiologic changes that occur in children who are ill enough to be hospitalized. Opportunistic sampling can provide robust drug disposition data and overcome some of the challenges encountered by traditional drug studies. In this Methodologic Progress Note, we describe the utility of opportunistic sampling as a research tool for hospitalists, in partnership with clinical pharmacologists, to study drug pharmacokinetics (PK) in hospitalized children.

Opportunistic sampling relies on the use of blood samples that are ordered for clinical purposes, and its use is endorsed by the Pediatric Trials Network.^2,5 Opportunistic sampling approaches have two types: sparse sampling and scavenged or remnant sampling. In sparse opportunistic sampling, additional blood is obtained at the same time clinical samples are ordered, avoiding the need for additional punctures.⁵ This approach requires bedside personnel to obtain additional blood that is sent to the research team for further processing. Scavenged sampling relies on leftover residual blood from clinical samples.^2,5 After the clinical laboratory performs the laboratory test ordered by the clinical team, the research team can scavenge residual blood for measurement of drug concentrations. When drug concentrations are measured from multiple patients, clinical pharmacologists can perform population PK modeling to characterize the pharmacokinetics of the drug and its variability within the population level.

The Figure shows how scavenged samples from hypothetical patients could be used to generate a PK curve. In this example, three patients are admitted for osteomyelitis and treated with the same antibiotic administered every eight hours, as shown by the theoretical concentration versus time profiles in the top panel. To determine the effectiveness of treatment and timing of transition to enteral antibiotics, the clinical team orders C-reactive protein (CRP) approximately every 48 hours for each patient. Each patient has his/her first dose of antibiotic at a different time of day depending on the time of admission or surgical drainage. Therefore, the timing of the blood draw with respect to the most recent antibiotic dose varies between patients even if blood draws are ordered at the same time for all patients (ie, 4 am lab draw). For patient 1, the blood draws occur approximately three to five hours after the second and eighth antibiotic doses (Figure, top panel). After the clinical laboratory measures the CRP, the research team scavenges residual blood from the lab samples and measures antibiotic concentrations. The antibiotic concentrations are then plotted on a concentration vs time after most recent dose. (Figure, bottom panel). Patient 2 has blood drawn five to seven hours after the first and seventh antibiotic doses. The third patient has blood drawn within two hours after the second and eighth antibiotic doses. As more samples are collected from additional patients, population PK modeling provides a robust description of the central tendency of the concentration vs time profile. More important, as more patients are included, the interpatient variability in concentrations can be described within the population, which often cannot be performed well with the smaller numbers of patients enrolled in traditional PK studies.

Opportunistic sampling has advantages over traditional intensive PK studies that often require multiple blood draws (typically >8-10) within one dosing interval to adequately describe the phases of absorption, distribution, metabolism, and elimination. The number of vascular punctures can be painful if blood cannot be drawn from existing vascular access, and the large amount of blood (sometimes >1 mL/sample) required for these studies can be impractical, burdensome, and even dangerous in young children and neonates. Scavenged sampling reduces the risk of anemia because no additional blood is drawn beyond what is obtained for clinical purposes, and it does not disrupt nursing workflow or add to nursing workload. Approval to use scavenged blood requires approval from the institutional review board. At some institutions, the consent to treat form on admission may address the use of scavenged samples and therefore allow for waiver of consent. In addition, the consent process may occur retroactively after samples are collected. These methods lead to increased enrollment.

Limitations in this approach are that drugs may degrade over time in whole blood or processed samples. Therefore, the process by which the clinical laboratory stores the residual blood after clinical tests must be understood, and the stability of the drug or metabolite of interest in blood or plasma over time must be ensured. In addition, residual blood may not be present after a clinical test, and recording times of the drug administration and lab draws may be inaccurate.^2,5

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Pediatric hospital medicine (PHM) is in the midst of an exciting period of growth. In 2016, the American Board of Medical Specialties approved the petition for PHM to become the newest pediatric subspecialty, taking PHM on a divergent path from the Focused Practice in Hospital Medicine designation established for adult hospitalists. Establishment as a subspecialty has allowed PHM to define the unique skills and qualifications that hospitalists bring to patients and the healthcare system. These skills and qualifications are delineated in the PHM core competencies and national fellowship curriculum.^1,2 In order to realize the vision of PHM to improve care for hospitalized children described by Roberts et al.,³ concerted efforts are needed to train and retain a workforce that is equipped with the skills to catalyze improvements in inpatient pediatric care. We discuss challenges and opportunities facing PHM in workforce development, sustainability of clinical work models, and interhospital collaboration.

The development of PHM as a subspecialty was driven by a number of factors.⁴ The acuity of hospitalized children has increased significantly, with a population comprised of more children with complex chronic conditions and/or technology dependence, serious complications of acute conditions, and acute mental health problems. At the same time, the medical and behavioral conditions seen by outpatient general pediatricians have become more complex and time intensive, with these practitioners less likely to work in inpatient settings. Hospitalist care has positive impacts on healthcare efficiency and value, and both parents and primary care pediatricians report high levels of satisfaction with the healthcare delivered by PHM services.⁴

A national count of the number of pediatric hospitalists is currently lacking. Conservative estimates suggest that at least 3,000 pediatric hospitalists currently practice in the United States.⁵ These hospitalists have highly varied scopes of practice and work across diverse settings—more diverse, perhaps, than any other pediatric subspecialty. Although difficult to quantify, we estimate that approximately one-third of pediatric hospitalists in the US work in community hospitals and the remainder practice at children’s hospitals.⁶ Many of the needs of hospitalized children differ across these settings, and the roles and challenges faced by hospitalists in these settings correspondingly differ. Community hospitalists frequently take active roles in newborn care and emergency department consultation, often without the support of other pediatric subspecialties.⁷ In contrast, hospitalists working at children’s hospitals more frequently care for highly complex patients, often collaborate across multiple specialties and assume nonclinical roles in quality improvement (QI), research, and medical education.

Residents graduating in July 2019 were the last cohort of residents eligible to pursue PHM subspecialty certification via the practice pathway. Accordingly, future residency graduates interested in PHM subspecialty certification will need to complete a PHM fellowship at an accredited program in the US or Canada. Since 2008, PHM fellowship directors have met yearly to collaborate and share best practices,⁸ developing the two-year fellowship curriculum that forms the basis for the American Board of Pediatrics training pathway.² The curriculum allows significant flexibility to meet diverse needs, including tailored content for fellows planning to practice in community settings, fellows planning research careers, medicine-pediatrics hospitalist careers, and those desiring increased training in QI, medical education, or leadership/administration.² In the spring of 2019, Pediatric Research in Inpatient Settings (PRIS) leadership, directors of existing PHM fellowship programs, and national academic society representatives met to develop a fellows’ research curriculum, training resources, and guidelines around scholarship expectations.⁹ This collaboration aims to accelerate the growth of high-quality clinical training and scholarship to benefit hospitalized children across many different settings.

Such collaboration is essential to address an emerging workforce challenge in PHM. Although the number of PHM fellowship positions is expected to grow in the coming years, there is currently a shortage relative to the anticipated demand. With approximately 2,800 US pediatric residents graduating annually and data indicating that 7% of graduating residents enter and remain in PHM for at least five years,^10,11 almost 200 fellowship spots may be needed each year. As of November 2019, 77 fellowship positions were available for residents graduating in 2020,¹² which is less than half of the potential demand. To address this mismatch, the PHM Fellowship Directors’ Council has led an annual training for new and potential fellowship directors, and 18 new programs are under development.¹³ However, this growth may be inadequate to meet the needs of the field. The extent to which limited PHM fellowship positions will adversely affect the pipeline of pediatricians pursuing PHM is unknown.

Efforts to support institutions in creating and expanding fellowship programs will be needed to address the potential shortage of fellowship positions. Continued guidance from the PHM Fellowship Directors’ Council in the many aspects of fellowship program development (eg, curriculum design, assessment) will be crucial in this endeavor. Furthermore, given that fellowships must support fellows to conduct scholarly work and demonstrate evidence of robust faculty scholarly activities to attain accreditation, an essential area of focus is faculty development. Considering barriers such as lack of time, mentorship, and resources, some divisions interested in starting a fellowship may find it challenging to achieve these standards.¹⁴ However, hospitalists are often engaged in areas such as QI and medical education, and there is potential to turn ongoing work into meaningful scholarship with appropriate guidance. Many of our supporting organizations (eg, Academic Pediatric Association, American Academy of Pediatrics, and Society of Hospital Medicine) provide training programs for faculty in areas such as educational scholarship, research, and QI; however, more may be needed. Leaders of PHM programs will need to be mindful and creative in accessing local, regional, and national resources to invest in faculty development.

As a group, pediatric hospitalists report high levels of satisfaction with their jobs.¹¹ Despite this finding, there are a number of threats to the sustainability of current work models, some of which are unique to pediatrics given the overall lower patient volumes and greater seasonal variation compared with adult hospital medicine. Both university and community-based hospitalist programs report high weekend, overnight, and in-house clinical effort.^7,15 Recent studies reported that a significant proportion of PHM program leaders (50% of division directors at university-affiliated programs and 37% of community program leaders) perceive their program to be unsustainable.^7,15 Among university-affiliated programs, a higher burden of weekend work as well as university employment were associated with perceived unsustainability, while no specific program or employer characteristic was associated with this perception in community programs.

These findings indicate that efforts are needed to address PHM program sustainability and that different work models and interventions may be needed for university-based and community PHM programs. Wide variability exists in the ways that programs address overall clinical burden, with strategies including census caps, seasonal expansion of coverage, and formal back-up systems.^7,15 Additional potential solutions may include differential weighting or financial incentives for nights and weekends, support for nonclinical work, loan repayment programs, and competitive salaries.¹¹ In addition, structuring clinical and nonclinical roles to facilitate career development and advancement may enhance career longevity.¹⁵ Lessons learned from pediatric emergency medicine (PEM), which developed as a field a few decades ahead of PHM, may predict future challenges. A 2015 survey of PEM faculty found that despite a 15% decrease in weekly work hours over a 15-year period, a substantial number of PEM faculty report concerns about burnout, with 40% reporting a plan to decrease their clinical workload and 13% planning to leave the field within five years.¹⁶ Like PEM, the field of PHM may benefit from the development of best practice guidelines to improve well-being and career longevity.¹⁷

The culture of collaboration within PHM places the field in a solid position to address both workforce challenges and barriers to high-quality care for hospitalized children. There are several hospital-based learning networks actively working to strengthen our knowledge base and improve healthcare quality. The PRIS network (www.prisnetwork.org) aims to improve healthcare for children through multihospital studies, boasting 114 sites in the US and Canada. Numerous collaborative projects have linked hospitalists across programs to tackle problems ranging from handoff communication¹⁸ to eliminating monitor overuse.¹⁹ The Value in Inpatient Pediatrics network has similarly leveraged collaborations across multiple children’s and community hospitals to improve transitions of care²⁰ and care for common conditions such as bronchiolitis, febrile infants, and asthma.²¹ These networks serve as models of effective collaboration between children’s hospitals and community hospitals, more of which is needed to increase research and QI initiatives in community hospitals, where the majority of US children receive their hospital-based care.^6,22

With the rapid growth of scholarly networks in research, QI, and education, PHM has a solid infrastructure on which to base continued development as a subspeciality. Building on this infrastructure will be essential in order to address current challenges in workforce development, fellowship training, and program sustainability. Ultimately, achieving a strong, stable, and skilled workforce will enable PHM to fulfill its promise of improving the care of children across the diversity of settings where they receive their hospital-based care.

Disclosures

Dr. Leyenaar provides consultative services to the American Board of Pediatrics Foundation, which is not associated with this manuscript. Drs. Wang and Shaughnessy have no disclosures

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

Traditional mentorship models may not be adequate for academic hospitalists. The traditional dyadic mentorship model, in which a senior principal investigator and research mentee collaborate for career advancement, is well suited for basic science or clinical research. In contrast, areas of academic hospital medicine such as quality improvement, medical education, hospital operations, point-of-care ultrasound, and clinical expertise may be less suited to this traditional mentoring model. In addition, experienced mentors are limited and those available are often overcommitted or have inadequate time due to responsibilities with other leadership roles. Senior mentors may also be limited because of our specialty’s focus on clinical practice rather than longitudinal research or projects.⁹ There are other limitations of traditional mentorship that are applicable to all fields of academic medicine, including disparate goals, expectations, levels of commitment, and the inherent power differential between the mentor and mentee.¹⁰

In this perspective, we discuss our experience with implementing an alternative and complementary mentorship strategy called facilitated peer mentorship with junior faculty hospitalists in the Division of General Internal Medicine at New York–Presbyterian/Weill Cornell Medical Center.

In facilitated peer mentoring programs, faculty typically work collaboratively in groups of three to five with other faculty who are of similar rank, and a faculty member of a higher academic rank works with the group in meeting their scholarly goals.¹¹ The role of the facilitator is to ensure a safe and respectful learning environment, foster peer collaboration, and redirect the group to draw upon their own experiences. Each junior faculty member serves as both a mentor and mentee for each other with bidirectional feedback, guidance, and support in a group setting. This model emphasizes collaboration, peer networking, empowerment, and the development of personal awareness.¹⁰ A number of academic medical centers have used peer mentoring as a response to the challenges encountered in the traditional dyad model.¹² To our knowledge, the only published example of a peer mentoring model in academic hospital medicine is in the form of a research-in-progress conference.¹³ While this example addresses peer-mentored research, there is a gap in other areas of academic hospital medicine with mentoring needs—most of all in personal development and career satisfaction.

We piloted a 12-month facilitated peer mentoring program for new hospitalists. The goal of the program was for junior faculty hospitalists to develop a better understanding of their own identity and core values that would enable them to more confidently navigate career choices, enhance their work vitality and career satisfaction, and develop their potential for leadership roles in academic hospital medicine. Each year, a cohort of four to five incoming hospitalists from different backgrounds, interests, and experience were grouped with a more experienced colleague at an associate professor rank who expressed interest and was selected by our section chief to lead the program. The program was required for new hospitalists and consisted of six 90-minute sessions every two months. The attendance rate was 100% and was ensured by scheduling all sessions at the beginning of the academic year with dates agreed upon by all participants. An e-mail reminder was sent one week prior to each session. Each session had assigned readings and an agenda for discussions (see Table for details).

Our evaluation of the program after two years with two separate cohorts included qualitative feedback through an anonymous survey for participants; in addition, qualitative feedback was collected in a one-hour, in-person discussion and reflection with each cohort. We learned several lessons from the feedback we received from program participants. First, our impression was that the career experience of the junior faculty member had a significant impact on the perceived value of group meetings. For those who entered the hospitalist workforce immediately upon completing their terminal training in internal medicine, the exercise of considering different career versions of themselves had added value in promoting thinking outside-the-box for career opportunities within hospital medicine. Academic hospitalists and general internists more broadly, tend to have broad interests that fuel their passions but may also make it more difficult to define long-term goals. One junior faculty member paired her life interests in global medical education with building an international collaboration with other academic hospitalist programs; another faculty member gained confidence and expanded her network of collaborators by designing a research pilot study on hospitalist-initiated end-of-life discussions. In both cases, the junior faculty identified the facilitated peer mentoring program as a strong influence in finding these opportunities. Peer mentoring at the time of entry into the field of hospital medicine, when many have undefined career goals, can be helpful for navigating this issue at the start of a career. On the other hand, those who had already worked as a hospitalist for one or two years and joined the program found less value in career planning exercises.

Second, junior faculty differed in their desire for scope and depth of the curriculum. Some preferred more frequent sessions with more premeeting readings and self-assessments in fewer topics that were covered more longitudinally. A proposed example of a longitudinal topic was defining and refining existing mentoring relationships. Others found it useful to cover more ground with a potpourri of themes; they wanted to cover different knowledge, skills, and attitudes considered important for personal growth and career development, such as negotiation, leading teams, and managing conflict. We recommend the goals of the peer group be defined collaboratively at the beginning of new groups to respond to the needs of the group.

Third, junior faculty varied in how they viewed the goal of the program on a spectrum ranging from social support to mentorship. On one end of the spectrum, the program provided a safe venue for colleagues to convene periodically to discuss work challenges; this group found the support from peers to be helpful. On the other end, some found value in the coaching and mentoring from peers and the experienced facilitator that guided personal growth and career development.

Our pilot program has several limitations. This is a single-center program with a relatively small number of participants; thus, our experience may be unique to our institution and not representative of all academic hospital medicine programs. We also did not obtain any quantitative metrics of evaluation—mixed methods should be used in the future for more rigorous program evaluation. Finally, our peer mentoring model may not cover all domains of mentoring such as sponsorship for career advancement, provision of resources, and promotion of scholarship, though we mentioned an anecdote of scholarship that resulted from networking and redefining of goals that were facilitated through this program. Scholarship is certainly an important feature of academic medicine—other peer mentoring programs may consider forming groups based on research interests to address this gap. A tailored curriculum toward research and scholarship may garner more interest and benefit from participants interested in advancement of scholarship activities.

Overall, the field of hospital medicine is growing rapidly with junior faculty who need effective mentorship. Facilitated peer mentorship among small groups of junior faculty is a feasible and pragmatic mentorship model that can complement more traditional mentorship models. We discovered wide-ranging and contrasting experiences in our program, which suggests that peer mentorship is not a one-size-fits-all approach. However, facilitated peer mentorship can be a highly adaptable and alternative approach to mentorship for diverse groups of hospitalists, including general internal medicine, pediatrics, and other subspecialties. Future studies including multicenter, randomized trials comparing peer mentoring and traditional dyadic mentoring are needed. It is imperative for the field to investigate best practices in mentorship to sustain the rapid growth of hospital medicine and training the new generation of academic hospitalists.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

“How much teaching time will I get in my first year on faculty?” Leaders at academic hospitalist programs know to expect this question from almost every applicant. We also know that we will be graded on our response; the more resident-covered service time, the better. For some applicants, this question is a key litmus test. Some prospective faculty choose to pursue academic hospital medicine because of their own experiences on the wards during residency. They recall the excitement of leading a team of interns and students under the wing of a seasoned attending, replete with chalk talks, clinical pearls, and inspired learners. Teaching time is more quantifiable than mentorship quality and academic opportunity, more important than salary and patient load for some, and more familiar than relative value unit expectations.

Over the past two decades, academic hospitalist programs have steadily grown,¹ but their teaching footprints have not.^2,3 Although historically some academic hospitalists spent almost 100% of their clinical time on teaching services, work hour rules and diversification of resident clinical time toward outpatient and subspecialty activities have decreased the amount of general medicine ward time for residents.² In addition, as academic medical centers broadened their clinical networks, inpatient volumes exceeded the capacity of teaching services. Finally, several large academic medical centers and healthcare networks are acquiring or building additional hospitals, increasing the number of medical beds that are staffed by hospitalists without residents.⁴

In our experience, as academic healthcare systems continue to grow and hospital medicine programs rapidly expand to meet clinical needs, the percentage of clinical time spent on a traditional ward teaching service continues to decrease. In several academic hospitalist programs, the majority of faculty effort is now devoted to direct care,⁵ with limited resident-covered ward time spread across a larger group of faculty. The 2018 State of Hospital Medicine Report suggests that our experience is not unique with academic programs caring for adults reporting that 31% of clinical work was on traditional ward teaching services, 16% on direct care services with intermittent learners, and 53% on nonteaching services.⁵

This current state of affairs raises a number of questions as follows:

• How can hospitalist program leaders take advantage of existing resident teaching opportunities?
• How should those teaching opportunities be allocated?
• What nontraditional teaching venues exist in academic medicine?
• How can faculty develop their teaching skills in an environment with limited traditional ward teaching time.

We believe that these changes require us to redefine what it means to be an academic hospitalist, both for existing faculty and for prospective faculty whose views of academic hospital medicine may have been shaped by role models seen only in their clinical teaching role.

Is reduced teaching time the new normal or will the pendulum swing back toward more resident teaching time for academic hospitalists? The former is likely the case. None of the current trends in medical education point to an expansion of residents in the inpatient setting. Although there may be some opportunities to assume general medicine attending time is currently covered by primary care physicians and subspecialists, in several programs, hospitalists already cover the overwhelming majority of general medicine teaching services.

Although there may be occasional opportunities for academic hospitalist programs to develop new teaching roles with residents or fellows (for example, by expanding to community sites with residency programs or to subspecialty teaching services, or by creating hospital medicine fellowships and resident or student electives), the reality is that we as hospitalists will need to adapt to direct care as the plurality of our work.

How should we allocate traditional teaching time among our faculty? Since it is a coveted—but relatively scarce—resource, teaching time should be allocated thoughtfully. Based on our collective experience, academic hospitalist groups have taken a variety of approaches to this challenge, including forming separate clinical groups at the same institution (a teaching faculty group and a nonteaching group),⁶ requiring all hospitalists to do some amount of direct care to facilitate distribution of teaching time or having merit or seniority-based teaching time allocation (based on teaching evaluations, formal teaching roles such as program director status, or years on faculty).

Each approach to assigning teaching time has its challenges. Hospitalist leaders must manage these issues through transparency about the selection process for teaching rotations and open discussion of teaching evaluations with faculty. It is also critical that the recruitment process set appropriate expectations for faculty candidates. Highlighting academic opportunities outside of teaching residents, including leadership roles, quality improvement work, and research, may encourage applicants and current hospitalists to explore more varied career trajectories. Hospitalists focusing on these other paths may elect to have less teaching time, freeing up opportunities for dedicated clinician educators.

What other ward-based teaching opportunities might be available for academic hospitalists who do not have the opportunity to attend on traditional resident teaching teams? As supervisory requirements for residents have been strengthened, expansion of teaching into the evening and overnight hours to supervise new admissions to the teaching services has been one approach to augment teaching footprints.^7,8

In addition, nontraditional teaching teams such as attending/intern teams (without a supervising resident) or attending/subintern (fourth-year medical student) teams have been developed at some institutions.⁹ Although allowing for additional exposure to learners, these models require a more hands-on approach than traditional teaching teams, particularly at the start of the academic year. Finally, as hospitalist teams have grown to include advanced practice providers (APPs), some programs have established formal teaching programs to address professional development needs of these healthcare professionals.^10,11

How do we help junior faculty who have the potential to be talented educators succeed in teaching when they have limited opportunities to engage with residents on clinical services? One approach is to encourage hospitalists to participate in resident didactic sessions such as “morning report” and noon conference. Another approach is to focus on teaching other learners. For example, several academic medical centers provide opportunities for hospitalists to engage in student teaching, either on the wards or via classroom instruction. In addition, as mentioned previously, APPs who are new to hospital medicine are an engaged audience and represent an opportunity for hospitalist educators to utilize and hone their teaching skills. Finally, organizing lectures for nursing colleagues is another way for the faculty to practice “chalk talks” and develop teaching portfolios.

Hospitalists can also leverage their expertise to build systems in which academic hospitalists are teaching each other, creating a culture of continuous learning. These activities may include case conferences, morbidity and mortality conferences, journal clubs, clinical topic updates developed by and for hospitalists, simulation exercises, and other group learning sessions. Giving hospitalists the opportunity to teach each other allows for professional growth that is not dependent on the presence of traditional learners.

Philosophically, a key question is “What makes ‘academic’ academic?” Traditionally, academic hospitalist positions were synonymous with resident teaching or, for a small number of academic hospitalists, significant funded research. In an era where teaching residents may no longer be part of the job description for many hospitalists at academic medical centers, what distinguishes these positions from 100% clinical positions and what are the implications for academic hospital medicine?

Although data regarding why hospitalists seek “nonteaching” positions at academic medical centers are lacking, we believe that these jobs remain popular due to opportunities that are perceived to be unique to academic medical centers. These include more flexible scheduling (academic programs may be less likely to have seven-on/seven-off schedules), exposure to research and cutting-edge technology, opportunities to care for tertiary and quaternary care patients, collaboration with academic peers and experts in the field, and interaction with a range of learners, including medical, pharmacy, advanced practitioner, and other students.

Understanding the motivation of candidates who apply for academic hospital medicine positions—aside from supervising/teaching residents—will be an important goal for academic hospitalist leaders to ensure future success in staffing growing programs and creating sustainable academic hospitalist careers. As resident teaching time decreases, implementing robust faculty or professional development programs to address the broader interests and needs of academic hospitalist faculty will be increasingly important. Sehgal et al. described one such program for faculty development,¹² and a more recent paper outlines a faculty development program focused on quality improvement and patient safety.¹³ These types of programs provide opportunities for academic hospitalists to engage in academic pursuits that are independent of residency programs.

Therefore, what do we tell the eager faculty applicant? First, we should not hide from the honest answer, ie, new faculty may not get as much resident teaching time as they would like or expect. Although we want hospitalists to maintain integral involvement in residency training programs, we also want to build a culture of clinical excellence, scholarship, and continuous learning that is not dependent on directly teaching residents. We should highlight the unique opportunities of academic hospital medicine, including teaching other learners, caring for tertiary/quaternary care patients, working with colleagues who are leaders in their field, and engaging in research and quality improvement work. By capitalizing on these opportunities, we can actively redefine what makes “academic” academic and ensure that we sustain academic hospital medicine as a desirable and rewarding career.

Disclosures

The authors have nothing to disclose.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.

Hip fractures are a significant cause of morbidity and mortality among elderly patients. Patients with fragility hip fractures often carry multiple comorbid diagnoses with a significant risk of perioperative complications. After hip fracture, 30-day mortality has been reported as 3.3% to 17.2% with one-year mortality as high as 50%.¹

Multidisciplinary care,^2-5 surgery within 24 hours (h),^6-12 use of regional peripheral nerve blocks,^13-16 restrictive blood transfusion strategies,^17,18 tranexamic acid (TXA) use,¹⁹ pharmacologic deep venous thrombosis (DVT) prophylaxis,²⁰ surgical site infection prevention protocols,²¹ early mobilization,²² and nutritional optimization^23-25 have been individually shown to improve outcomes in hip fracture patients.

Our program sought to define, standardize, and implement evidence-based best practices to improve clinical care and outcomes of patients with hip fractures. We convened a Center for Musculoskeletal Care (CMC) Hip Fracture Oversight Group that included surgeons and advanced practice providers from Orthopedics; physicians from Internal Medicine Hospitalist, Geriatrics, Emergency Medicine, and Anesthesia; and representatives from rehabilitation services, nursing, care management, pharmacy, and performance improvement. With clinical input from all involved services, we developed evidence-based protocols to standardize the care of patients with fragility hip fractures from the time of the patient’s evaluation in the emergency room to discharge and outpatient rehabilitation. The program was operationalized in February 2016.

This project was considered by the Yale University institutional review board (IRB) to be a quality improvement and, therefore, exempted from IRB approval.

Yale-New Haven Hospital is composed of two main campuses. The York Street Campus (YSC) is the Level 1 Trauma Center. The St. Raphael’s Campus (SRC) houses the CMC nursing units for elective lower extremity arthroplasty and spine procedures. Prior to 2016, patients with hip fractures were cared for equally at both Yale-New Haven Hospital campuses. Patients were admitted to both medical and surgical services with no standardization of hip fracture care processes. Surgeons were assigned based on availability. Frequently, patients were added on to the operating room (OR) schedule and did not undergo surgery until off-hours and after a prolonged waiting period.

Medical comanagement of patients with fragility hip fractures at our institution predated the start of our CMC Integrated Fragility Hip Fracture Program (IFHFP). Comanagement was instituted in 2012 at YSC and in 2014 at SRC but without standardized protocols. The IFHFP began in February 2016 with the centralization of all patients with fragility hip fractures to the SRC at Yale-New Haven Hospital. Emergency medical services directed patients with suspected hip fractures to the designated campus. A dedicated hip fracture OR was allocated daily with a hip fracture surgeon assigned by a shared community and faculty surgeon call schedule. Patients were encouraged but not required to accept care from the on-call hip fracture surgical attending. Anesthesia was notified of the arrival of a patient with a hip fracture in the emergency department, and if the patient consented and qualified, a single-shot femoral nerve block was performed. Patients were screened for nasal staphylococcal colonization and treated with povidone-iodine nasal decolonization, chlorhexidine wash, and antibiotics determined by staphylococcal status and type of surgical procedure planned. Preoperative and postoperative order sets were implemented that dictated the care processes as outlined in Table 1. Surgeons determined the choice of operative intervention as per usual; this included internal fixation and partial or total hip replacement. Detailed medical and surgical protocols are included in Appendix A.

There were 275 consecutive patients with hip fractures admitted to SRC in the baseline year (January 1, 2015 to December 31, 2015) and 434 patients with hip fractures admitted in the intervention year (January 1, 2018, to December 31, 2018) after consolidation of the program to the single Yale-New Haven Campus and implementation of standardized care processes. Patient demographic data including age, sex, ethnicity, body mass index, and American Society of Anesthesiologists physical status classification were evaluated for the baseline year and intervention year and reported in Table 2. There were no differences in the demographics of patients between baseline and intervention years.

From baseline year to intervention year, 30-day mortality, transfusion, adverse effects of drugs, length of stay, unexpected return to OR, and time to OR were all significantly reduced. Mortality within 30 days decreased from 8.0% to 2.8%. The results are displayed in Table 3. No significant difference was seen in the incidence of venous thromboembolism, sepsis, myocardial infarctions, readmission at 30 days, or mechanical surgical fixation complications.

Patients with fragility hip fractures are a medically complex and vulnerable population. The goal of the CMC IFHFP was to standardize the care of these high-risk patients in an effort to reduce time to the OR, perioperative medical complications, time spent in the hospital, and ultimately mortality.

The barriers to implementing coordinated, multidisciplinary care are significant. In our case, we had a fragmented care model with fragility hip fracture patients cared for at two campuses, on different nursing units, with both community and faculty surgeons providing operative care, and with no predesignated primary team. We structured our program for equal sharing of call between community and faculty surgeons. However, there was distrust among the physician groups: Primary care physicians were concerned that their referral lines with orthopedic surgical colleagues would be fractured by the new shared call. Surgeons doubted that patients would be distributed equally among community and faculty practices. Hospitalists feared that comanagement would mean surgeons abdicating responsibility for care. Surgeons worried that routine medical involvement would delay surgery and prolong the length of stay with excessive testing. In order to achieve consensus, address concerns, and allay fears, we engaged the primary care and surgeon leadership for their support at the onset of the program and held monthly large group meetings and many smaller sessions to advance objectives. We meticulously tracked data and frequently reported out to the involved groups.

As it is well established that operative intervention on a hip fracture is best completed within 24 h to optimize a patient’s clinical outcomes, critical interventions were the designation of a hip fracture OR starting midday and expectation that surgery be performed the day after admission for medically cleared patients. Surgeons were able to book elective cases or outpatient clinic time in the morning. The morning hours prior to surgery allowed time for any final medical optimization, preoperative nursing care, and family discussions. Most surgeries were then completed by the primary OR staff during standard operating hours. Patients were out of the postanesthesia care unit and settled back on the orthopedic nursing unit in the early evening without a prolonged period of nil per os, bed rest, or sleep interruption.

While our protocol expected surgery the day after admission for medically cleared patients, we used surgery within 24 h as a simple metric to compare baseline with intervention outcomes. With our hip fracture OR block time beginning midday, the majority of our medically cleared hip fracture patients would receive surgical treatment within 24 h of admission. Our data show a significant improvement in timeliness of surgical intervention from 41.8% of patients to the OR within 24 h in 2015 to 55% in 2018. In 2017, we conducted an interval four-month audit involving a detailed chart review of all patients for whom surgery was delayed beyond 24 h from hospital admission. Chart review identified anticoagulation as the primary reason for surgical delay. Of patients who were eligible for surgery (medically stabilized and not therapeutically anticoagulated), 90% underwent surgery within 24 h during this four-month period in 2017. This compares to an overall rate of surgery within 24 h of 57% during the calendar year 2017. We did not perform a subgroup analysis of outcomes in patients with time to OR of 24-36 h. From this study, we are therefore unable to draw any conclusion regarding time to surgery and mortality.

Our dedicated OR hip fracture block time was changed from 7:30 am to 12:30 pm during 2016 per surgeon request (Figure). Patients admitted within the 24-hour time period from 7 am the day prior to 7 am the day of the OR block time undergo surgery in the 12:30 pm time slot. Any patient admitted from 7 am until 12:30 pm is not scheduled until the following day’s OR block time and would hence have a surgical delay of 30 h or more. To better understand the impact of the later OR block time, we included the outcome variable of time to OR of greater than 24 h but less than or equal to 36 h. We demonstrated a significant increase in the proportion of patients going to the OR in 24 h without an increase in patients waiting for 24 to 36 h for their surgery.

Transfusion rate reduction from 46.6% to 28.1% was achieved primarily by the implementation and strict enforcement of a policy to avoid transfusing asymptomatic patients with hemoglobin >7.0 g/dL. In addition, we recommended TXA using standard perioperative arthroplasty dosing of 1 g intravenously (IV) at the time of incision followed by 1 g IV 3 h later in the postanaesthesia care unit. However, adherence to TXA recommendations was poor. A year-long audit (February 2017 to February 2018) demonstrated that only 29% of patients undergoing hip fracture surgery received the recommended TXA. After the conclusion of the study period of this review, we revised our TXA protocol to include an infusion at the time of admission and subsequent perioperative doses. The expanded TXA protocol (with clear exclusion criteria) has been “hard-wired” into our electronic perioperative order sets. We are tracking TXA compliance on a weekly basis. We anticipate that earlier TXA administration and improved compliance will further reduce transfusion rates.

We reduced the adverse effects of medications with two initiatives: First, dedicated hip fracture order sets with medications selected and dosed specifically for the geriatric population were launched at the onset of the IFHFP in 2016. Second, in coordination with our regional anesthesia team, patients who met criteria underwent a single-shot femoral nerve block upon diagnosis of the hip fracture. Patients reported up to 24 h of nonnarcotic pain relief with the femoral nerve block.

Prior to the introduction of the IFHFP, surgeons determined DVT prophylaxis based on their personal preference. Many of our surgeons were concerned that standardizing DVT prophylaxis to enoxaparin would increase the risk of surgical site bleeding, hematoma, infection, and reoperation. With data tracking and periodic reporting, we were able to reassure our surgeons: We demonstrated a reduction in the rate of patients unexpectedly requiring a return to the OR from 5.1% in 2015 to 0% in 2018.

We did not find a significant difference in mechanical complications due to surgical fixation during the index admission. Most mechanical complications do not present within the index admission and, therefore, would not be identified by this metric. Furthermore, in this phase of the program, we did not seek to change or standardize intraoperative surgical processes outside of surgical site infection prevention measures. Surgical technical quality and variation among surgeons is an area of ongoing evaluation within our program. We have begun a surgical quality review process with an expert review of postoperative radiography, beginning with fixation of nondisplaced femoral neck fractures, feedback to surgeons, and tracking of mechanical complications beyond the index admission. The surgical quality outcomes will be presented in a future manuscript.

Anticoagulation use is common in patients with hip fractures because of the high prevalence of comorbid conditions such as atrial fibrillation and venous thromboembolic disease. Direct oral anticoagulants (DOACs) are now commonly used in place of the vitamin K antagonist, warfarin. Our inability to efficiently reverse the DOACs compounded by surgeon unfamiliarity with these agents led to extreme caution in the timing of OR, with most patients delayed a full 48 h from the last dose of their prescribed DOAC. After recognizing the impact of anticoagulation on the timing of surgery, we convened a multidisciplinary group to determine rational guidelines for the timing of surgery in patients on chronic anticoagulation based on the bleeding risk of the planned operative procedure. These guidelines were instituted in December 2018, so their impact is not reflected in this review.

Our results showing a reduction in length of stay and mortality cannot be explained by any one intervention. We propose that the standardization of all processes and protocols, the establishment of clear expectations among all the medical and nursing personnel, and the shorter time spent waiting for surgery all contributed to the length of stay reduction. Likewise, the decrease in time to OR, reduction in time spent in the hospital, fewer transfusions, adverse effects of medication, and surgical complications requiring a return to the OR have all likely contributed to the significant reduction in mortality. The efforts of the orthopedic nursing team certainly contributed: The CMC nurses led the efforts to standardize surgical site infection bundle care, reduce indwelling bladder catheter use, and together with physical therapy, mobilize patients out of bed for meals postoperatively. The strong focus on teamwork, data tracking, feedback and accountability, and the desire for continued improvement may have been the strongest drivers in this program’s success.

Our results showed a nonsignificant increase in 30-day readmission from 9.1% to 12.5%. One limitation of this study is that we did not track specific readmission diagnoses to better understand trends in diagnoses or indications for hospital readmission. Going forward, we are reviewing readmissions to better understand opportunities to improve our inpatient processes and transitions of care.

This an evolving project. We have expanded our use of TXA in an effort to further reduce transfusion rates. We have adjusted our protocols for patients admitted on DOACs and warfarin to allow more rapid surgical intervention. We have initiated a surgical quality review process in which surgical fixation is reviewed with timely feedback to the operating surgeon. We are working closely with the skilled nursing facilities to extend our rehabilitation and nursing care protocols beyond the acute care setting. We are measuring patient engagement with a brief discharge survey specific to the CMC IFHFP. We continue to seek feedback from our referring primary care physicians to improve communication at times of care transition.

One of the limitations of a quality improvement project such as this one is the inability to identify the effect of each individual intervention. We can conclude that the totality of the multidisciplinary project reduced mortality in our hip fracture population, but we cannot report the relative effect of each process change. Another center seeking to replicate this success cannot determine from this research how to prioritize their resources to achieve a similar outcome.

How we care for the fragility hip fracture patient after hospital discharge is critical and unaddressed in this current study. A limitation of our current program is the lack of consistent postdischarge bone health management—which we are working to address. Also related to postdischarge management, we have partnered with a network of preferred skilled nursing facilities to standardize the care and decrease the length of stay. These data will be published separately.

We understand that our experience at the CMC is unique and specific to our care environment. This is a single site study and may not be generalizable to other centers. Nonetheless, the principles of multidisciplinary care, evidence-based protocol development, technological integration of protocols through order sets, and data tracking with feedback and accountability are the essential elements of our success that can be generalized to other institutions.

The CMC at Yale School of Medicine and Yale-New Haven Hospital IFHFP provides a model for implementing well-documented evidence-based interventions to standardize the care of patients with fragility hip fractures. The IFHFP yielded reduced mortality, length of stay, blood transfusion utilization, adverse effects of medications, unexpected return to the OR, and time to the OR.

Acknowledgments

The authors thank the work of the Center for Musculoskeletal Care Hip Fracture Oversight Group, program surgeons, and community primary care leaders: Olukemi Akande, MD, Mark Altman, MD, Diren Arsoy, MD, John Aversa, MD, Michael Connair, MD, Leo Cooney, MD, Kenneth Donohue, MD, David Gibson, MD, Gail Haesche, RN, MS, ACM-RN, Carol Just, MSN, NEA-BC, RN, Patricia Kenyon, RN, ACM, Francis Lee MD, Michael Leslie, MD, Michael Lucchini, MD, Christopher Lynch, MD, Rowland Mayor, MD, Tara Messina, PT, Lorraine Novella, RN, Paul Oliver, PA-C, Vivek Parwani, MD, Joseph Quaranta, MD, Lee Rubin, MD, Derek Shia, MD, Jeff Sumner, MD, John Tarutis, Arya Varthi, MD, Anuruddha Walaliyadda, MD, Daniel Wiznia, MD, Shirvinda Wijesekera, MD, Joseph Wu, MD, Brad Yoo, MD, and James Yue, MD.