Clinical trial NCT06817213: Patient-Centered Decision Support for Eosinophilic Esophagitis
Official title: Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: tailored educational materials
general educational materials
online surveys
decision aid
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: measured as the proportion of eligible patients that consent to participate in the study
timeFrame: Recruitment period approximately 18 months
measure: Acceptability: measured on a 4-point Likert scale
timeFrame: Approximately 4 months
Secondary outcomes:
measure: Effectiveness (within-subjects)
timeFrame: Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)
measure: Effectiveness (between-subjects)
timeFrame: Approximately 4 months
measure: Preparation for Decision Making (PrepDM) scale
timeFrame: Approximately 4 months
measure: Completion rates
timeFrame: Approximately 4 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joy Chang, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: