The IBD&me Randomized Controlled Trial

NCT03695783 | Completed

• 1 other identifier: 37998665
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient perceptions of decisional conflict

  one day after the clinic visit

• Patient satisfaction

  one day after the clinic visit

• Disease control and IBD-related quality of life

  at baseline and two months after the clinic visit

• Initiation or switch of a treatment

  at baseline and two months after the clinic visit

Study Arms (2)

Online decision aid called IBD&me

EXPERIMENTAL

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

Standardized educational material

ACTIVE COMPARATOR

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

Interventions

Online decision aid called IBD&me OTHER

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.

Online decision aid called IBD&me

Standardized educational material OTHER

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.

Standardized educational material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not speak English
• Does not have access to the Internet

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Given the study design and intervention, it is not possible to ensure the blinding of patients and physicians. However, we will attempt to address the limitations resulting from a lack of blinding: * 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Services Research

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 4, 2018
• Study Start: March 6, 2019
• Primary Completion: March 14, 2021
• Study Completion: May 14, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)