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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05835063
Other study ID # HUM00231699
Secondary ID 5K23HL145096-04
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2023
Est. completion date June 7, 2024

Study information

Verified date June 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 62
Est. completion date June 7, 2024
Est. primary completion date June 7, 2024
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.

Study Design


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)
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