The IBD&me Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Standardized educational material; Other: Online decision aid called IBD&me

• Registration Number: NCT03695783
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2019-03-06
• Primary Completion: 2021-03-14
• Study Completion: 2021-05-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized educational material	Standardized educational material	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.
Online decision aid called IBD&me	Online decision aid called IBD&me	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.

Primary Outcome Measures

Name	Time	Method
Patient perceptions of shared decision-making	one day after the clinic visit	To assess the impact of the IBD\&me decision aid on patient perceptions of shared decision-making, compared to a standardized education arm. Patient perception of shared decision-making, as measured by the 9-item Shared Decision-Making Questionnaire (SDM-Q-9)

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	one day after the clinic visit	Patient satisfaction as measured by four domains of the Patient Satisfaction Questionnaire relating to communication, general satisfaction, interpersonal manner, and time spent with the doctor (PSQ-18)
Patient perceptions of decisional conflict	one day after the clinic visit	Patient perceptions of decisional conflict, as measured using the informed and values clarity subscales of the Decisional Conflict Scale
Disease control and IBD-related quality of life	at baseline and two months after the clinic visit	Disease control and IBD-related quality of life, as measured by the IBD-Control questionnaire
Initiation or switch of a treatment	at baseline and two months after the clinic visit	Questionnaire about IBD therapy use

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States