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

Duke University

Status: Not yet enrolling

Conditions: Decision Making; Neonatal Critical Illness; Pediatric Critical Illness

Treatments: Behavioral: BRIDGE intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07390773

Pro00117670

R01HD118955 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 495 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Child inclusion criteria will include:

• Age < 5 years
• Admission to a critical care unit within the preceding 14 days
• An anticipated serious health care decision, defined as a decision about initiating, not initiating, or withdrawing life-sustaining treatment and/or a decision about major intervention.

Parent inclusion criteria will include:

• Age ≥ 18 years
• The ability speak English or Spanish.

Clinician inclusion criteria will include

• Clinical team member of an enrolled child and parent in the intervention group
• Completion of residency or equivalent training.

Exclusion criteria

• Children, parents or clinicians who do not meet the inclusion criteria above.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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495 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: BRIDGE intervention

Usual Care

No Intervention group

Description:

Usual Care