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Набор скоро начнётся NCT07390773

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

Без фазы С лечением Decision Making Neonatal Critical Illness Pediatric Critical Illness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: BRIDGE intervention.
Кому может быть актуально
Состояния в реестре: Decision Making, Neonatal Critical Illness, Pediatric Critical Illness. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Parent Preparation for Decision Making, as measured by the PrepDM [Срок оценки: Approximately 10-14 days following enrollment]
  • Decisional Regret, as measured by the Decision Regret Scale [Срок оценки: Approximately 6 and 12 months following enrollment]
Вторичные конечные точки (4)
  • Shared Decision Making Quality, as measured by the CollaboRATE (Parent version) [Срок оценки: Approximately 10-14 days following enrollment]
  • Communication Quality, as measured by the Interpersonal Processes of Care (IPC-18) [Срок оценки: Baseline; Approximately 10-14 days following enrollment]
  • Decisional Conflict, as measured by the Decisional Conflict Scale [Срок оценки: 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 [Срок оценки: Approximately 6 and 12 months following enrollment]

Критерии участия

Критерии включения

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.

Критерии исключения

  • Children, parents or clinicians who do not meet the inclusion criteria above.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 3 центра
  • University of California San Francisco — San Francisco
  • Johns Hopkins University — Baltimore
  • Duke University — Durham

Публикации

  • 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

Идентификаторы

NCT: NCT07390773 · Pro00117670 · R01HD118955

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗