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

Heart Failure NYHA Class III Clinical Trial

— CHATT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835063
• Other study ID #: HUM00231699
• Secondary ID: 5K23HL145096-04
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Cynthia Smith
• Phone: 734-615-0590
• Email: csmithw[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)