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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK129784-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General education control group | Active Comparator | General educational materials |
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| Decision support tool group | Experimental | Tailored educational materials |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Recruitment period approximately 18 months |
| 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. | Approximately 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelcie Brophy | Contact | 734-615-0531 | kelcieb@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joy Chang, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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".
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| 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. |
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| 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 | Approximately 4 months |
| 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. | Approximately 4 months |
| 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 | Approximately 4 months |
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |