Patient-Centered Decision Support for Eosinophilic Esophagitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: General education control, Decision support tool.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study
Overview
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.
Interventions
- Behavioral 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. - 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 pr
Primary outcome measures
- Feasibility: measured as the proportion of eligible patients that consent to participate in the study [Time frame: Recruitment period approximately 18 months]
- Acceptability: measured on a 4-point Likert scale [Time frame: Approximately 4 months]
Secondary outcome measures (4)
- Effectiveness (within-subjects) [Time frame: Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)]
- Effectiveness (between-subjects) [Time frame: Approximately 4 months]
- Preparation for Decision Making (PrepDM) scale [Time frame: Approximately 4 months]
- Completion rates [Time frame: Approximately 4 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06817213 · HUM00257119 · 1K23DK129784-01A1