The IBD&me Randomized Controlled Trial

Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial

Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.

The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm.

Context: Navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (IBD) can be challenging for patients who are considering biologic therapies as a treatment option. Thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction.

Objective: The principal objective of this study is to assess the impact of an online decision aid called IBD&me on patient perceptions of shared-decision making as compared to a standardized education arm.

Hypothesis: IBD&me, through optimizing shared-decision making (SDM) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an SDM tool.

Design: Pragmatic multicenter randomized controlled trial in IBD outpatient care

1. Intervention: IBD&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace
2. Control arm: Standardized, high-quality educational material from the Crohn's & Colitis Foundation

Inclusion Criteria:

• 18 years of age or older
• Have ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or inflammatory bowel disease unclassified (IBD-U)
• Have experienced IBD related symptoms in the 30 days before screening
• Considering discussing biologic therapies for controlling his or her IBD at the next clinic visit
• Have an IBD-related visit scheduled at least 7 days and no later than 3 months following screening

Exclusion Criteria:

• Does not speak English
• Does not have access to the Internet