Clinical trial NCT03695783: The IBD&me Randomized Controlled Trial
Official title: Impact of a Web-Based Decision Aid on Shared Decision-Making in Patients With Inflammatory Bowel Disease: The IBD&me Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient perceptions of shared decision-making
timeFrame: one day after the clinic visit
Secondary outcomes:
measure: Patient perceptions of decisional conflict
timeFrame: one day after the clinic visit
measure: Patient satisfaction
timeFrame: one day after the clinic visit
measure: Disease control and IBD-related quality of life
timeFrame: at baseline and two months after the clinic visit
measure: Initiation or switch of a treatment
timeFrame: at baseline and two months after the clinic visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brennan Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: