NCT03695783

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	Online decision aid called IBD&me	Patients randomized to IBD\&me will be directed to go through the website at least 2 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit.
OTHER	Standardized educational material	Patients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource at least 2 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit.

Timeline

• Start date: 2019-03-06
• Primary completion: 2021-03-14
• Completion: 2021-05-14
• First posted: 2018-10-04
• Last updated: 2021-12-02

Locations

1 site across 1 country: United States