Clinical trial NCT05835063: A Study to Improve Physician-Youth Communication and Medical Decision Making
Official title: We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Keywords: Caregiver/parent
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-28
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Physician Overall Satisfaction With the We Chatt Intervention Based on the Post Clinician Survey
timeFrame: 2 weeks (after intervention)
measure: Patient/Caregiver Overall Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
timeFrame: 2 weeks (after intervention)
Secondary outcomes:
measure: Physician Satisfaction With the We Chatt Intervention From Physicians Based on the Post Clinician Survey
timeFrame: 2 weeks (after intervention)
measure: Patient/Caregiver Satisfaction With the We Chatt Intervention Based on the Patient/Caregiver Survey
timeFrame: 2 weeks (after intervention)
measure: Time (Measured in Minutes) to Complete We Chatt the Intervention by Clinicians
timeFrame: 30 minutes (approximately)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Melissa Cousino, PhD
role: PRINCIPAL_INVESTIGATOR
References: