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

N/ANot Yet RecruitingNCT07390773

Duke University495 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

495

Conditions

Decision Making Neonatal Critical Illness Pediatric Critical Illness

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: 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.

Time frame: Approximately 6 and 12 months following enrollment

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.

Time frame: 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.

Time frame: 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.

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

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.