Eosinophilic Esophagitis
Conditions
Keywords
tailored educational materials, general educational materials, online surveys, decision aid
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.
Interventions
BEHAVIORALGeneral 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.
BEHAVIORALDecision 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 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.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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".
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: measured as the proportion of eligible patients that consent to participate in the study | Recruitment period approximately 18 months | The study aims to achieve at least 20% consented for eligible patients. |
| Acceptability: measured on a 4-point Likert scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness (within-subjects) | 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 |
| Effectiveness (between-subjects) | 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 |
| Preparation for Decision Making (PrepDM) scale | 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. |
| Completion rates | 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 |
Countries
United States
Contacts
CONTACTKelcie Brophy
PRINCIPAL_INVESTIGATORJoy Chang, MD, MS
University of Michigan
Outcome results
None listed