Patient-Centered Decision Support for Eosinophilic Esophagitis

NCT06817213 | Recruiting

• 2 other identifiers: HUM002571191K23DK129784-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

tailored educational materials; general educational materials; online surveys; decision aid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Effectiveness (within-subjects)

  Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)

• Effectiveness (between-subjects)

  Approximately 4 months

• Preparation for Decision Making (PrepDM) scale

  Approximately 4 months

• Completion rates

  Approximately 4 months

Study Arms (2)

General education control group

ACTIVE COMPARATOR

General educational materials

Behavioral: General education control

Decision support tool group

EXPERIMENTAL

Tailored educational materials

Behavioral: Decision support tool

Interventions

General education control BEHAVIORAL

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.

General education control group

Decision support tool BEHAVIORAL

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.

Decision support tool group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joy Chang, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelcie Brophy

CONTACT

734-615-0531; kelcieb@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Participants (n-20) will be enrolled into the control arm (general education about EoE), then 20 patients will go into the DA arm. Providers will not be formally consented to have their clinics screened for participants. The study team will coordinate with Gastroenterology and Allergy providers about the initiation of the study. Providers will be informed that the study is launching and given the opportunity to "opt-out".

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)