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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Decision Making; Neonatal Critical Illness; Pediatric Critical Illness
• Intervention / Treatment: Behavioral: BRIDGE intervention

• Study Type: Interventional
• Enrollment (Estimated): 495
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittany Nave; Phone Number: 919-684-8087; Email: brittany.nave@duke.edu
• Study Contact Backup: Name: Amanda Fristoe, MD; Email: amanda.fristoe@duke.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
      • Contact: Yasmeen Rezaishad; Phone Number: 415-476-3785; Email: Yasmeen.Rezaishad@ucsf.edu
      • Principal Investigator: Hannah Glass, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
      • Contact: Jenny Shepard; Phone Number: 410-614-3834; Email: jshepar1@jhmi.edu
      • Principal Investigator: Renee Boss, MD
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
      • Contact: Amanda Fristoe; Phone Number: 919-684-4833; Email: amanda.fristoe@duke.edu
      • Principal Investigator: Monica Lemmon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared Decision Making Quality, as measured by the CollaboRATE (Parent version)	This survey is a 3-item measure, and each item can be rated from 0 to 9. Higher scores indicate a higher degree of shared decision making.	Approximately 10-14 days following enrollment
Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18)	For this measure, we will administer the communication and decision making subscales. Each item uses a response scale of 1-5. Higher scores indicate that the labeled interpersonal process occurred more often.	Baseline; Approximately 10-14 days following enrollment
Decisional Conflict, as measured by the Decisional Conflict Scale	The Decisional Conflict Scale includes 16 items across 5 domains (score range: 0-100). Higher scores indicate a higher degree of decisional conflict.	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	Participants will complete the PROMIS self-efficacy for managing chronic conditions measure, which has been adapted for use by parents. This measure assesses parental self-efficacy in managing their child's medications and treatments. Participants will complete the questions in the health care information or decision making domain. Items ask participants to indicate their current level of confidence in each behavior and have 5 response options (range 1-5). Higher scores indicate a higher level of confidence.	Approximately 6 and 12 months following enrollment

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Monica Lemmon, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00117670; R01HD118955 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No