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

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835063
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
80
1
2
24
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: We Chatt communication tool
  • Behavioral: Usual/standard care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Physician overall satisfaction with the We Chatt intervention based on the post clinician survey [2 weeks (after intervention)]

    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. Patient/Caregiver overall satisfaction with the We Chatt intervention based on the parent/caregiver survey [2 weeks (after intervention)]

    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.

  3. Patient overall satisfaction with the We Chatt intervention based on the patient survey [2 weeks (after intervention)]

    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.

Secondary Outcome Measures

  1. Physician satisfaction with the We Chatt intervention from physicians based on the post clinician survey [2 weeks (after intervention)]

    Physicians will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)

  2. Parent/Caregiver satisfaction with the We Chatt intervention based on the parent/caregiver survey [2 weeks (after intervention)]

    Parent/Caregiver will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)

  3. Patient satisfaction with the We Chatt intervention based on the patient survey [2 weeks (after intervention)]

    Patients will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)

  4. Time (measured in minutes) to complete We Chatt the Intervention by clinicians [30 minutes (approximately)]

    Number of minutes to complete the intervention will be collected on clinician survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Melissa Cousino, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melissa Cousino, Associate Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier:
NCT05835063
Other Study ID Numbers:
  • HUM00231699
  • 5K23HL145096-04
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Melissa Cousino, Associate Professor of Pediatrics, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2023