The IBD&me Randomized Controlled Trial

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Brennan Spiegel，Cedars-Sinai Medical Center

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

April 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patient perception of shared decision-making[ Time Frame: 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)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Patient satisfaction[ Time Frame: 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[ Time Frame: 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[ Time Frame: at baseline and two months after the clinic visit ]
Questionnaire about IBD therapy use

Descriptive Information

Brief Title ^ICMJE

The IBD&me Randomized Controlled Trial

Official Title ^ICMJE

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

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.

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 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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Interventional
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

Condition ^ICMJE

Intervention ^ICMJE

Other: Online decision aid called IBD&me
Patients randomized to IBD&me will be directed to go through the website 10 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit.
Other: Standardized educational material
Patients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource 10 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit.

Study Arms

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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

152

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 15, 2019

Estimated Primary Completion Date

April 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 10 days and no later than 3 months following screening Exclusion Criteria: - Does not speak English - Does not have access to the Internet

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Brennan Spiegel，Cedars-Sinai Medical Center

Study Sponsor ^ICMJE

Cedars-Sinai Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Cedars-Sinai Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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