Patient-Centered Decision Support for Eosinophilic Esophagitis

Not Applicable

Recruiting

• Conditions: Eosinophilic Esophagitis

• Registration Number: NCT06817213
• Lead Sponsor: University of Michigan

Brief Summary

The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making.

This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies.

The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Status Verified: 2025-04
• Study Start: 2025-04-16
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-04
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy & immunology clinic,
• Able to speak and read English.

Exclusion Criteria

• Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.
• Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
• Patients that are terminally ill
• Patients that do not have an email address or reliable access to the internet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Feasibility: measured as the proportion of eligible patients that consent to participate in the study	Recruitment period approximately 18 months	The study aims to achieve at least 20% consented for eligible patients.
Acceptability: measured on a 4-point Likert scale	Approximately 4 months	Measured on a 4-point Likert-scale (1) Very Unhelpful to (4) Very Helpful. Analyzed as high scores indicate more helpful.

Secondary Outcome Measures

Name	Time	Method
Effectiveness (within-subjects)	Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)	Objective eosinophilic esophagitis knowledge measured on 8 true/false/I don't know questions where wrong or "I don't know" answers are given 0 points and correct answers are given 1 point. Minimum points=0 and Maximum points=8
Preparation for Decision Making (PrepDM) scale	Approximately 4 months	Preparation for Decision making (PrepDM scale) score is a 10-item questionnaire and is scored on a 0-100 scale, where higher scores indicate participants being well prepared to make decisions after reviewing a decision aid (DA). The Prep-DM scale may be adapted slightly to meet the needs of the target population and the developed decision support tool.
Effectiveness (between-subjects)	Approximately 4 months	Objective eosinophilic esophagitis knowledge measured on 8 true/false/I don't know questions where wrong or "I don't know" answers are given 0 points and correct answers are given 1 point. Minimum points=0 and Maximum points=8
Completion rates	Approximately 4 months	Measured as the proportion of people that consented and completed all study measures, the pre-test, post-test, and 3-month follow-up survey

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States