Back to resultsA Study to Improve Physician-Youth Communication and Medical Decision Making (CHATT)
Primary Purpose
Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
We Chatt communication tool
Usual/standard care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring Caregiver/parent
Eligibility Criteria
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.
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
We Chatt communication tool
Usual care
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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)
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)
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)
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.
Full Information
NCT ID
NCT05835063
First Posted
April 17, 2023
Last Updated
October 18, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05835063
Brief Title
A Study to Improve Physician-Youth Communication and Medical Decision Making
Acronym
CHATT
Official Title
We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this study is improving patient-centered communication for young people with advanced heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Keywords
Caregiver/parent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
We Chatt communication tool
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
We Chatt communication tool
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual/standard care
Intervention Description
Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.
Primary Outcome Measure Information:
Title
Physician overall satisfaction with the We Chatt intervention based on the post clinician survey
Description
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.
Time Frame
2 weeks (after intervention)
Title
Patient/Caregiver overall satisfaction with the We Chatt intervention based on the parent/caregiver survey
Description
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.
Time Frame
2 weeks (after intervention)
Title
Patient overall satisfaction with the We Chatt intervention based on the patient survey
Description
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.
Time Frame
2 weeks (after intervention)
Secondary Outcome Measure Information:
Title
Physician satisfaction with the We Chatt intervention from physicians based on the post clinician survey
Description
Physicians will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)
Time Frame
2 weeks (after intervention)
Title
Parent/Caregiver satisfaction with the We Chatt intervention based on the parent/caregiver survey
Description
Parent/Caregiver will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)
Time Frame
2 weeks (after intervention)
Title
Patient satisfaction with the We Chatt intervention based on the patient survey
Description
Patients will answer 1 question on a scale from 0-10 (with 0 being worst and 10 being best)
Time Frame
2 weeks (after intervention)
Title
Time (measured in minutes) to complete We Chatt the Intervention by clinicians
Description
Number of minutes to complete the intervention will be collected on clinician survey.
Time Frame
30 minutes (approximately)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Smith
Phone
734-615-0590
Email
csmithw@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Cousino, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Smith
Phone
734-615-0590
Email
csmithw@umich.edu
First Name & Middle Initial & Last Name & Degree
Melissa Cousino, PhD
Phone
734-615-2577
Email
melcousi@umich.edu
First Name & Middle Initial & Last Name & Degree
Melissa Cousino, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Improve Physician-Youth Communication and Medical Decision Making
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