About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children, parents or clinicians who do not meet the inclusion criteria above.
Trial design
Parallel
Treatments tested in this trial
BRIDGE intervention
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Duke University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator