Building Relationship, Improving Dialogue, and Growing Empathy (BRIDGE): An Intervention to Support Decision Making for Critically Ill Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BRIDGE intervention.
- Who it may be relevant to
- Registry conditions: Decision Making, Neonatal Critical Illness, Pediatric Critical Illness. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Shared Decision Making Quality, as measured by the CollaboRATE (Parent version) [Time frame: Approximately 10-14 days following enrollment]
- Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18) [Time frame: Baseline; Approximately 10-14 days following enrollment]
- Decisional Conflict, as measured by the Decisional Conflict Scale [Time frame: 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 [Time frame: Approximately 6 and 12 months following enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 3 centers
- University of California San Francisco — San Francisco
- Johns Hopkins University — Baltimore
- Duke University — Durham
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. PMID 40319938
Identifiers
NCT: NCT07390773 · Pro00117670 · R01HD118955