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NCT Number: NCT06817213

Patient-Centered Decision Support for Eosinophilic Esophagitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Joy Chang, MD, MS

PRINCIPAL_INVESTIGATOR

Kelcie Brophy

CONTACT

[email protected]

734-615-0531

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility: measured as the proportion of eligible patients that consent to participate in the study

    Time frame: Recruitment period approximately 18 months

    The study aims to achieve at least 20% consented for eligible patients.

  2. Acceptability: measured on a 4-point Likert scale

    Time frame: Approximately 4 months

    Measured on a 4-point Likert-scale (1) Very Unhelpful to (4) Very Helpful. Analyzed as high scores indicate more helpful.

Secondary outcomes

  1. Effectiveness (within-subjects)

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

    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

  2. Effectiveness (between-subjects)

    Time frame: Approximately 4 months

    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

  3. Preparation for Decision Making (PrepDM) scale

    Time frame: Approximately 4 months

    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.

  4. Completion rates

    Time frame: Approximately 4 months

    Measured as the proportion of people that consented and completed all study measures, the pre-test, post-test, and 3-month follow-up survey

Study contacts

Contact information is provided by the study sponsor or research team.

Kelcie Brophy

CONTACT

[email protected]

734-615-0531

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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