The IBD&me Randomized Controlled Trial

Cedars-Sinai Medical Center

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Standardized educational material; Other: Online decision aid called IBD&me

Study type: Interventional

Funder types: Other

Identifiers

NCT03695783

37998665

Details and patient eligibility

About

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.

Full 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

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 Control arm: Standardized, high-quality educational material from the Crohn's & Colitis Foundation

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Online decision aid called IBD&me

Experimental group

Description:

IBD&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for IBD at their own pace. It includes an educational component and an interactive exercise with a series of ratings tasks that generates a personalized preferences report for patients to share and discuss with their physician.

Treatment:

Other: Online decision aid called IBD&me

Standardized educational material

Active Comparator group

Description:

PDF file corresponding to the CCFA's online resource on biologic therapies, which is a well-researched and clearly presented overview of IBD biologic therapies, but without an active shared-decision making component.

Treatment:

Other: Standardized educational material