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Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
FROM PEDIATRICS