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

Not Applicable

Completed

• Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class II; Heart Failure NYHA Class IV

• Registration Number: NCT05835063
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-28
• Study Start: 2023-09-14
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07
• Status Verified: 2025-06
• Results First Submitted: 2025-06-03
• Results First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Results First Posted: 2025-06-18
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey	2 weeks (after intervention)	Satisfaction was based on the answers for 12 questions in which clinicians selected from a Likert scale from strongly disagree (1) -Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.
Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey	2 weeks (after intervention)	Parent/Caregiver completed 12 questions in which participants selected from a Likert scale from Strongly disagree (1) to Strongly agree (5). The scores ranged from 12-60; higher scores indicated greater satisfaction.

Secondary Outcome Measures

Name	Time	Method
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey	2 weeks (after intervention)	Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey	2 weeks (after intervention)	Patient/Caregiver answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)
Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians	30 minutes (approximately)	Number of minutes to complete the intervention was collected on clinician survey.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States