Patient having consultation with doctor in office

Inflammatory bowel disease (either Crohn’s disease or ulcerative colitis) affects an estimated 3 million Americans. Evidence has shown that patients have better health outcomes when they begin intensive treatment early, in particular starting with a combination therapy that uses at least two drugs. But treatment may have serious risks, including life-threatening infections and an association with lymphoma. Fearing adverse effects from these strong medications, patients may be hesitant to begin using them and adhere to treatment guidelines until they believe their disease is severe enough to deserve them.

Shared decision making (SDM)—patient-clinician collaboration aimed at directing healthcare decisions toward what matters most to patients—has been suggested as a way to improve communication and outcomes for early intensive therapy for Crohn’s disease. A new study authored by Yaara Zisman-Ilani, director of the Shared Decision Making Lab in the Department of Social and Behavioral Sciences, has tested an SDM program for Crohn’s treatment that shows the potential to improve disease management by personalizing and improving early decision making.

“The primary outcome was a statistically significant higher proportion of patients selecting combination therapy,” says Zisman-Ilani, who collaborated on the multicenter research trial, in which 14 gastroenterology practices in the US were randomly assigned to use either the SDM program or administer standard care (the control group). Partnering in the study were IBD experts from Dartmouth-Hitchcock Medical Center, Cedars-Sinai Medical Center, Brigham and Women's Hospital, Thomas Jefferson University Hospital, Icahn School of Medicine at Mount Sinai, University of Chicago Medicine, Cleveland Clinic, and University of Maryland School of Medicine. The research, newly published in Alimentary Pharmacology & Therapeutics, was led by Corey Siegel from Dartmouth-Hitchcock Medical Center and funded by the Agency for Healthcare Research and Quality. 

The SDM program included two tools; a web-based decision aid to help patients weigh the benefits and risks of available treatments for Crohn's disease, and PROSPECT (Personalized Risk and Outcome Prediction Tool), a web-based tool to predict an individual patient's risk of developing a Crohn's disease complication based on clinical, serologic, and genetic variables. Outcomes for patients given this intervention were compared with outcomes for those in a control group not given the SDM tools (that is, standard care).

A total of 158 adult patients with Crohn's disease within 15 years of their diagnosis, with no prior Crohn's disease complications, and who were candidates to receive immunomodulators or biologics, participated in the study. Among these, 99 received the intervention and 59 received standard care, and demographics were similar between groups. Participants in the SDM group more frequently chose combination therapy (25% versus 5% control, p< 0.001), had a significantly lower decisional conflict (p< 0.05), and had greater trust in their provider (p< 0.05).

“The SDM program helps patients understand which treatments are right for them, communicating the best available evidence so they can make informed decisions based on their preferences,” Zisman-Ilani says. “It leads to a higher acceptance of appropriate therapy, improved pattern of use with chosen therapy, and improved clinical outcomes.”

Treatments for IBD continue to advance, and breakthroughs using gene and cell therapy, which can bring new benefits and new concerns, mean the SDM program needs to be frequently updated to remain effective, Zisman-Ilani says. “SDM adaptation by top-tier IBD programs is a significant achievement,” she says. “We aim to continue developing more SDM tools to benefit patients in other gastroenterology settings and clinics such as the IBD program at Temple University Hospital.”