Patient-Centered Decision Support for Eosinophilic Esophagitis

Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Behavioral: General education control; Behavioral: Decision support tool

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelcie Brophy; Phone Number: 734-615-0531; Email: kelcieb@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Kelcie Brophy; Phone Number: 734-615-0531; Email: kelcieb@umich.edu
      • Principal Investigator: Joy Chang, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General education control group; General educational materials	Behavioral: General education control; Participants will complete an online survey before reviewing education material for eosinophilic esophagitis, prior to patient's clinical physician's appointment (this appointment is a standard of care visit). Participants will complete a follow-up survey approximately 3 months after the clinic appointment.
Experimental: Decision support tool group; Tailored educational materials	Behavioral: Decision support tool; Participants will complete an online survey before reviewing tailored educational materials for eosinophilic esophagitis prior to patient's clinical physician's appointment (this appointment is a standard of care visit). The intervention is a tailored, electronic decision support intervention with a patient-facing decision aid (DA) with three components-EoE knowledge/education, values clarifications, and communication. Tailored feedback from the patient will be given to the patient's provider prior to the visit to facilitate shared decision-making in the visit. Participants will complete a follow-up survey approximately 3 months after the clinic appointment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness (within-subjects)	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	Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)
Effectiveness (between-subjects)	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	Approximately 4 months
Preparation for Decision Making (PrepDM) scale	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.	Approximately 4 months
Completion rates	Measured as the proportion of people that consented and completed all study measures, the pre-test, post-test, and 3-month follow-up survey	Approximately 4 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Joy Chang, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: decision aid; online surveys; tailored educational materials; general educational materials
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis
• Other Study ID Numbers: HUM00257119; 1K23DK129784-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No