About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: General education control groupActive comparator 1 intervention

Group B: Decision support tool groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame

Recruitment period approximately 18 months

2

Acceptability: measured on a 4-point Likert scale

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

Time frame

Approximately 4 months

Secondary outcomes

1

Effectiveness (within-subjects)

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

Time frame

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

2

Effectiveness (between-subjects)

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

Time frame

Approximately 4 months

3

Preparation for Decision Making (PrepDM) scale

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.

Time frame

Approximately 4 months

4

Completion rates

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

Time frame

Approximately 4 months

Patient-Centered Decision Support for Eosinophilic Esophagitis

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts