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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV
• Intervention / Treatment: Behavioral: We Chatt communication tool; Behavioral: Usual/standard care

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care	Behavioral: Usual/standard care; Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.
Experimental: We Chatt communication tool	Behavioral: We Chatt communication tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey	Physicians answered 1 question on a scale from 0 to 10 (with 0 being worst and 10 being best)	2 weeks (after intervention)
Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey	Patient/Caregiver answered 1 question on a scale from 0 to 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 was collected on clinician survey.	30 minutes (approximately)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa Cousino, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Caregiver/parent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HUM00231699; 5K23HL145096-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No