Recruiting

BRIDGE Intervention

Sponsor:

Duke University

Code:

NCT07390773

Conditions

Decision Making

Neonatal Critical Illness

Pediatric Critical Illness

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

BRIDGE intervention

Study Details

Brief summary:

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.

Conditions

Decision Making

Neonatal Critical Illness

Pediatric Critical Illness

Study ID

NCT07390773

Start date

Aug 3, 2026

Status verified date

Jan, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

495 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

BRIDGE intervention

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.

Primary outcome measure

  • Parent Preparation for Decision Making, as measured by the PrepDM [ Time Frame: Approximately 10-14 days following enrollment ]
  • Decisional Regret, as measured by the Decision Regret Scale [ Time Frame: Approximately 6 and 12 months following enrollment ]

Central Contacts and Locations

Central contacts

Brittany Nave

919-684-8087brittany.nave@duke.edu

Amanda Fristoe, MD

amanda.fristoe@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Amanda Fristoe

919-684-4833amanda.fristoe@duke.edu

Principal Investigator:

Monica Lemmon, MD

More Information

Sponsor

Duke University

Last update posted

Sep 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-08.