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NCT Number: NCT07390773

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

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.

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Key information

Conditions

Decision Making Neonatal Critical Illness Pediatric Critical Illness

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Parent Preparation for Decision Making, as measured by the PrepDM

    Time frame: Approximately 10-14 days following enrollment

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

  2. Decisional Regret, as measured by the Decision Regret Scale

    Time frame: Approximately 6 and 12 months following enrollment

    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.

Secondary outcomes

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

    Time frame: Approximately 10-14 days following enrollment

    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.

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

    Time frame: Baseline; Approximately 10-14 days following enrollment

    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.

  3. Decisional Conflict, as measured by the Decisional Conflict Scale

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

    The Decisional Conflict Scale includes 16 items across 5 domains (score range: 0-100). Higher scores indicate a higher degree of decisional conflict.

  4. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Fristoe, MD

CONTACT

[email protected]

Brittany Nave

CONTACT

[email protected]

919-684-8087

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: BRIDGE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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