A computer-based decision aid aims to facilitate the complex discussions and decisions that face patients with lupus nephritis.
Under development at the University of Alabama at Birmingham, the Shared Decision-Making in Lupus Electronic tool (SMILE) describes in easy-to-understand modules the pathology of the disease, and what can happen if it progresses untreated. The tool also identifies treatment options and discusses the potential benefits of each one, as well as the risks. It can be folded into office visits, accessed during waiting times, or viewed at the patient’s leisure. Its creators hope that patients will experience more fruitful discussions with their physicians by learning more about these complicated concepts as they co-navigate the difficult decisions both must make.
UAB Photo
Dr. Jasvinder Singh
“Our intent was to figure out how best to offer the education about lupus and its treatments that women need when coming into a busy clinic,” said Jasvinder Singh, MD, who is leading the developmental team. “Everyone’s time is limited, and patients want information delivered quickly, but in a way they can understand.”
SMILE is the first tool of its kind for patients with lupus nephritis, said Alexa Meara, MD, one of the rheumatologists investigating it.
“There is just nothing out there like this for either lupus, or lupus nephritis,” said Dr. Meara, a rheumatologist at Ohio State University, Columbus. “Lupus nephritis is a heterogeneous relapsing-remitting disease with complex medical regimens. It can have cognitive impacts and affect fertility, but these are things that may happen over decades. Patients may not be ready to talk about them early on, but they must understand them. We would like to enable the conversation between physician and patient, so they’re on the same page with everyone’s values and concerns addressed on both sides.”
But getting everyone on the same page at the same time is challenging, said Dr. Singh, a rheumatologist and professor of medicine and epidemiology at the University of Alabama at Birmingham. “This is a bit of a dilemma and a challenge. What’s great about the lupus decision aid is that it is culturally and linguistically appropriate for patients of all backgrounds, races, ages, literacy levels, and socioeconomic statuses. This levels the playing field for patients who are trying to understand their diagnosis and options to the best of their abilities.”
Dr. Alexa Meara
Three years in the making, SMILE comprises several modules addressing different facets of lupus nephritis. In simple words and concepts, the tool informs patients about what lupus is and what it can do to the kidneys, the information gleaned from blood and urine tests and what it means, and the potential consequences of not treating lupus kidney disease. The heart of the program is its breakdown of treatment options.
“It helps patients understand why they may be getting these cancer medications, and what their side effects are,” Dr. Singh said. “The tool also walks them through a comparison of the medications, with one slide on each medication and its risks and benefits. We really focus on that – about 60%-70% of the tool is comparing the drugs.”
The decision aid also contains optional modules that patients can bypass or explore. “There are separate sections on the risks and benefits of corticosteroids, on pregnancy and lactation, and on preserving fertility.”
A complete click-through of the basic information takes about 20 minutes, Dr. Singh said. An ideal time for a patient to do so would be before the initial visit to discuss treatment options, which can be an overwhelming experience. The tool could be presented in several ways. In the office, preloaded iPads could be one vehicle. These could be standalone, or linked to the patient’s electronic health record, so that any entered information could be directly transferred. At home, patients could navigate to a web link for an online version.
The first visit is a crucial moment, he said, where patients can evolve into management partners, or leave even more confused than when they arrived.
“We aim to motivate and provide tools to the patient, so that the conversation isn’t just, ‘You have the disease and we can put you on this or that drug,’ ” Dr. Singh said. “You can lose the patient right away in this scenario, while you’re talking about so many things the patient isn’t even hearing you, because she’s thinking about other issues that are important in her life, completely overwhelmed with the shock of the diagnosis and with fear.”
The Patient-Centered Outcomes Research Institute (PCORI) has funded much of the work getting SMILE up and running, including a soon-to-be-published trial that favorably compared it against the educational standard: a paper pamphlet on lupus nephritis prepared by the American College of Rheumatology.
In this study, 301 high‐risk women with lupus kidney disease, including racial/ethnic minorities with low socioeconomic status, either received the pamphlet or the SMILE tool. The group was demographically diverse: 47% black, 26% Hispanic, 15% white, and 7% Asian. Other groups made up the remainder.
More patients rated the information in the decision aid to be excellent for understanding the impact of lupus (49% vs. 33%), risk factors (43% vs. 27%), medication options (50% vs. 33%), and evidence about medications (47% vs. 24%). About half of the tool users rated the ease of use of materials as excellent (51% vs. 38%). Women who used the tool also reported much less decisional conflict for immunosuppressive drugs and were much more likely to choose the treatment option most consistent with their values, having viewed information that mattered the most for the treatment decision.
PCORI continues to support the project, too. Dr. Singh just received a $2.2 million grant to investigate the tool in 16 clinics. The 2-year observational study has three aims:
• Identify physician attitudes and patient barriers toward the tool, to guide decisions about how to best implement it in its final form.
• Track changes in subjective and objective measures of implementation effectiveness.
• Identify opportunities for disseminating the tool and develop a step‐by‐step implementation guide for incorporating the decision aid tool into regular lupus clinic visits and care pathways.
The study will also look at some patient‐centered outcomes, including decision conflict, emergency department and inpatient visits, patient‐physician communication, and implementation success. Some practice-level outcomes will be assessed, including potential barriers to implementation. “The team will focus on context and strategy as facilitators and barriers to effective implementation of the lupus decision aid in busy, clinical practices of various types – for example, private versus academic, urban versus suburban, large versus small group practice,” according to the PCORI study description.
“This study can’t solve the entire problem about patients choosing treatment or no treatment, but it can provide a start to the conversation,” Dr. Singh said. “And my hope is that once it’s available, people will modify it to fit their needs, make adaptations and modifications to keep it relevant and valuable.”