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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
152
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.
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
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)
Time frame: one day after the clinic visit
Patient perceptions of decisional conflict
Patient perceptions of decisional conflict, as measured using the informed and values clarity subscales of the Decisional Conflict Scale
Time frame: one day after the clinic visit
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)
Time frame: one day after the clinic visit
Disease control and IBD-related quality of life
Disease control and IBD-related quality of life, as measured by the IBD-Control questionnaire
Time frame: at baseline and two months after the clinic visit
Initiation or switch of a treatment
Questionnaire about IBD therapy use
Time frame: at baseline and two months after the clinic visit
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