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

NCT ID: NCT05835063

Last Updated: 2025-06-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2024-06-07

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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We Chatt communication tool

Group Type EXPERIMENTAL

We Chatt communication tool

Intervention Type BEHAVIORAL

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 care

Group Type PLACEBO_COMPARATOR

Usual/standard care

Intervention Type BEHAVIORAL

Usual/standard care will be provided. Physicians randomized to the control arm will not receive training in the WE CHATT communication intervention.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* Patients 12-24 years old with heart failure symptoms meeting criteria for New York Heart Association (NYHA) Class II - IV heart failure

Exclusion Criteria

\- Not a physician at University of Michigan in the Division of Pediatric Cardiology


* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Melissa Cousino

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa Cousino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K23HL145096-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00231699

Identifier Type: -

Identifier Source: org_study_id

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