Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children

Part of paid clinical trials in San Francisco, California.

Sponsor
Duke University
Study ID
NCT07390773
Status
Not Yet Recruiting

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Conditions

  • Decision Making
  • Neonatal Critical Illness
  • Pediatric Critical Illness

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • BRIDGE intervention — BEHAVIORAL
    The BRIDGE intervention includes a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the health care team in the electronic health record.

Study Details

Parents of young children in the intensive care unit may be faced with decisions about their child's care. The Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE) intervention was designed to help support parents as they make decisions for their child and communicate with the health care team. The main questions this study aims to answer are: 1. Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child? 2. Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child? Participants will complete surveys at baseline and approximately 2 weeks, 6 months, and 12 months following enrollment. Some participants will also participate in interviews about their experiences.

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
495 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention
    In the BRIDGE intervention arm, parents will receive a paper-based tool that includes an introduction to decision-making, a values clarification exercise, and a question prompt list. The tool additionally prompts parents to share how they define decision-relevant concepts like quality of life and suffering for their child. The completed tool is shared with the medical team in the electronic health record.
  • No Intervention: Usual Care
    Usual Care

Primary Outcome Measure

Parent Preparation for Decision Making, as measured by the PrepDM [ Time Frame: Approximately 10-14 days following enrollment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Yasmeen Rezaishad
[email protected]
415-476-3785
Hannah Glass, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Jenny Shepard
[email protected]
410-614-3834
Renee Boss, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Amanda Fristoe
[email protected]
919-684-4833
Monica Lemmon, MD (PRINCIPAL_INVESTIGATOR)

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University of California San Francisco· San Francisco, CAJohns Hopkins University· Baltimore, MDDuke University· Durham, NC

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