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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD118955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Child inclusion criteria will include:
Parent inclusion criteria will include:
Clinician inclusion criteria will include
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brittany Nave | Contact | 919-684-8087 | brittany.nave@duke.edu | |
| Amanda Fristoe, MD | Contact | amanda.fristoe@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Monica Lemmon, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40319938 | Background | 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. |
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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 |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| Duke University | Durham | North Carolina | 27705 | United States |
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