Patient-Centered Decision Support for Eosinophilic Esophagitis

University of Michigan

Status: Enrolling

Conditions: Eosinophilic Esophagitis

Treatments: Behavioral: Decision support tool; Behavioral: General education control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06817213

1K23DK129784-01A1 (U.S. NIH Grant/Contract)

HUM00257119

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

General education control group

Active Comparator group

Description:

General educational materials

Treatment:

Behavioral: General education control

Decision support tool group

Experimental group

Description:

Tailored educational materials

Treatment:

Behavioral: Decision support tool