A Study to Improve Physician-Youth Communication and Medical Decision Making

Study Overview
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Brief Summary
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The goal of this study is improving patient-centered communication for young people with advanced heart disease.

Official Title
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We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making

Conditions
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Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Intervention / Treatment
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* Behavioral: We Chatt communication tool
* Behavioral: Usual/standard care


Participation Criteria
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Eligibility Criteria
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Physician Inclusion Criteria: Physician participants will be recruited from the Division of Pediatric Cardiology at the University of Michigan. All physicians with dedicated clinical effort will be eligible. Eligible physicians must anticipate remaining on staff >1 year Patient/Caregiver Inclusion Criteria: Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure One parent/caregiver of patient participants meeting inclusion criteria will also be eligible Physician Exclusion Criteria: - Not a physician at University of Michigan in the Division of Pediatric Cardiology Patient/Caregiver Exclusion Criteria: Patients with significant cognitive/developmental delay with potential to impact study participation will be excluded from the study due to the focus on physician-youth communication. Parents and parent/caregivers that are non-English speaking will be excluded from this pilot study.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 20 physicians will be recruited. 10 will be randomized to participate in the intervention arm and 10 will be randomized to the control arm. Participants and caretakers will account for approximately 60 enrolled participants that will not be randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: We Chatt communication tool<br> | Behavioral: We Chatt communication tool<br>* This arm involves the collaborative completion of a 2-page communication preferences document between a primary physician and an adolescent/young adult patient. Physicians will participate in a 1-hour training led by study principal investigator featuring didactic, multimedia, and experiential-based learning to support the facilitation of the WE CHATT intervention with patients.<br>|
| Placebo Comparator: Usual care<br> | Behavioral: Usual/standard care<br>* Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician overall satisfaction with the We Chatt intervention based on the post clinician survey | Satisfaction will be based on the answers for 12 questions in which clinician's select from a likert scale from strongly disagree (1) -Strongly agree (5). The scores ranging from 12-60; higher scores indicate greater satisfaction. | 2 weeks (after intervention) | 
| Patient/Caregiver overall satisfaction with the We Chatt intervention based on the parent/caregiver survey | Parent/Caregiver will complete 12 questions in which participants select from a likert scale from Strongly disagree (1) -Strongly agree (5). The scores ranging from 12-60; higher scores indicate greater satisfaction. | 2 weeks (after intervention) | 
| Patient overall satisfaction with the We Chatt intervention based on the patient survey | Patients will complete 12 questions in which participants select from a likert scale from Strongly disagree (1) -Strongly agree (5). The scores ranging from 12-60; higher scores indicate greater satisfaction. | 2 weeks (after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician satisfaction with the We Chatt intervention from physicians based on the post clinician survey | Physicians will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best) | 2 weeks (after intervention) | 
| Parent/Caregiver satisfaction with the We Chatt intervention based on the parent/caregiver survey | Parent/Caregiver will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best) | 2 weeks (after intervention) | 
| Patient satisfaction with the We Chatt intervention based on the patient survey | Patients will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best) | 2 weeks (after intervention) | 
| Time (measured in minutes) to complete We Chatt the Intervention by clinicians | Number of minutes to complete the intervention will be collected on clinician survey. | 30 minutes (approximately) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver/parent