The IBD&me Randomized Controlled Trial

Inflammatory Bowel Diseases Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695783
• Other study ID #: 37998665
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: May 14, 2021

Study information

• Verified date: November 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 14, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Initiation or switch of a treatment	Questionnaire about IBD therapy use	at baseline and two months after the clinic visit