The IBD&me Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: Online decision aid called IBD&me
* Other: Standardized educational material


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online decision aid called IBD&me<br>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. | Other: Online decision aid called IBD&me<br>* 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.<br>|
| Active Comparator: Standardized educational material<br>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. | Other: Standardized educational material<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perceptions of shared decision-making | 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) | one day after the clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perceptions of decisional conflict | Patient perceptions of decisional conflict, as measured using the informed and values clarity subscales of the Decisional Conflict Scale | one day after the clinic visit | 
| Patient satisfaction | 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) | one day after the clinic visit | 
| Disease control and IBD-related quality of life | Disease control and IBD-related quality of life, as measured by the IBD-Control questionnaire | at baseline and two months after the clinic visit | 
| Initiation or switch of a treatment | Questionnaire about IBD therapy use | at baseline and two months after the clinic visit |