Patient-Centered Decision Support for Eosinophilic Esophagitis

NCT ID: NCT06817213

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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".
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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General education control group

General educational materials

Group Type ACTIVE_COMPARATOR

General education control

Intervention Type 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 group

Tailored educational materials

Group Type EXPERIMENTAL

Decision support tool

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Joy Chang

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joy Chang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelcie Brophy

Role: CONTACT

734-615-0531

Facility Contacts

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Kelcie Brophy

Role: primary

734-615-0531

Other Identifiers

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1K23DK129784-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00257119

Identifier Type: -

Identifier Source: org_study_id

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