The IBD&me Randomized Controlled Trial

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03695783

Collaborator

(none)

152

Enrollment

Location

Arms

26.3

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Other: Online decision aid called IBD&me Other: Standardized educational material	N/A

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Investigator)

Masking Description:

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.

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Mar 6, 2019

Actual Primary Completion Date :

Mar 14, 2021

Actual Study Completion Date :

May 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT03695783

Other Study ID Numbers:

37998665

First Posted:

Oct 4, 2018

Last Update Posted:

Dec 2, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Dec 2, 2021