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

NCT05835063 | Completed Results

• 2 other identifiers: HUM002316995K23HL145096-04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Keywords

Caregiver/parent

Outcome Measures

Primary Outcomes (2)

• Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey

  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.

  2 weeks (after intervention)

• Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey

  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.

  2 weeks (after intervention)

Secondary Outcomes (3)

• Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey

  2 weeks (after intervention)

• Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey

  2 weeks (after intervention)

• Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians

  30 minutes (approximately)

Study Arms (2)

We Chatt communication tool

EXPERIMENTAL

Behavioral: We Chatt communication tool

Usual care

PLACEBO COMPARATOR

Behavioral: Usual/standard care

Interventions

We Chatt communication tool BEHAVIORAL

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.

We Chatt communication tool

Usual/standard care BEHAVIORAL

Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.

Usual care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure

You may not qualify if:

• \- Not a physician at University of Michigan in the Division of Pediatric Cardiology
• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Melissa Cousino
• Organization: University of Michigan

melcousi@med.umich.edu

(734) 936-4220

Study Officials

• Melissa Cousino, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: September 14, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)