Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2019-03-06
2021-05-14
Brief Summary
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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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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
* Patients and the physicians will be informed of the study protocol, but will not be provided accurate information about the specific primary outcome (i.e. comparison between IBD\&me and the Crohn's \& Colitis Foundation of America (CCFA) resource). The informed consent document will keep participants blind to the study goals.
* Physicians will be kept blinded of the patient's assignment group until the clinic visit.
* Data will be collected by an independent researcher. Study investigators and the data analyst will remain blinded until all follow-up data is obtained and the primary analysis is finalized.
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 have access to the Internet
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Brennan Spiegel
Director, Health Services Research
Principal Investigators
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Brennan Spiegel, MD, MSHS
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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37998665
Identifier Type: -
Identifier Source: org_study_id