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

NCT07390773 | Not Yet Recruiting

• 2 other identifiers: Pro00117670R01HD118955
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 3

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. 1.Do parents who receive the BRIDGE intervention report being better prepared to make decisions for their child?
2. 2.Do parents who receive the BRIDGE intervention report less regret about the decisions they made for their child?

Conditions

Decision Making; Neonatal Critical Illness; Pediatric Critical Illness

Outcome Measures

Primary Outcomes (2)

• Parent Preparation for Decision Making, as measured by the PrepDM

  Items can be summed and scored. Score ranges from 0-100, where a higher score indicates higher perceived preparedness for decision making.

  Approximately 10-14 days following enrollment

• Decisional Regret, as measured by the Decision Regret Scale

  Decisional Regret will be measured by the Decision Regret Scale (DRS): The DRS is a 5- item scale used to measure distress or remorse after a health care decision.

  Approximately 6 and 12 months following enrollment

Secondary Outcomes (4)

• Shared Decision Making Quality, as measured by the CollaboRATE (Parent version)

  Approximately 10-14 days following enrollment

• Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18)

  Baseline; Approximately 10-14 days following enrollment

• Decisional Conflict, as measured by the Decisional Conflict Scale

  Approximately 10-14 days following enrollment; Approximately 6 and 12 months following enrollment

• Parent Self-efficacy, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions

  Approximately 6 and 12 months following enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: BRIDGE intervention

Usual Care

NO INTERVENTION

Usual Care

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years
• The ability speak English or Spanish.
• Clinical team member of an enrolled child and parent in the intervention group
• Completion of residency or equivalent training.

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Lemmon ME, Bansal S, Nanduri N, Davalos A, Glass HC, Lord B, Moline K, Pilon B, Sharpe R, Brandon D, Hong H, Samsa G, Cox CE, Pollak KI. Feasibility of an Intervention to Support Shared Decision-Making for Critically Ill Infants. J Pediatr. 2025 Aug;283:114632. doi: 10.1016/j.jpeds.2025.114632. Epub 2025 May 2.

  PMID: 40319938 BACKGROUND

Study Officials

• Monica Lemmon, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Nave

CONTACT

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

Amanda Fristoe, MD

CONTACT

amanda.fristoe@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)