Patient-Centered Decision Support for Eosinophilic Esophagitis

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06817213
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: General education control group
    General educational materials
  • Experimental: Decision support tool group
    Tailored educational materials

Primary Outcome Measure

Feasibility: measured as the proportion of eligible patients that consent to participate in the study [ Time Frame: Recruitment period approximately 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Kelcie Brophy
[email protected]
734-615-0531
Joy Chang, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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