Family Bridge Program

Официальное название

Family Bridge Program Randomized Controlled Trial

Обзор

Pediatric healthcare disparities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address disparities related to communication and system navigation in the inpatient setting; given the established links between these and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a broad population of children and their families, The Family Bridge Program (FBP). The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest. In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children at risk for disparities, including those who prefer a language other than English for their medical care.

Вмешательства

• Поведенческое Family Bridge Program
  The Family Bridge Program consists of 7 components, delivered by a trained lay navigator, the Guide. The program includes: (1) orientation to the hospital, unit, room, and hospital resources (e.g., toiletries, loaner phone chargers); (2)unmet social needs assessment, followed by connection to appropriate resources (e.g., food vouchers, community-based transportation); (3)communication and cultural preference assessment (eg, preferred language, comfort asking questions, and health-related cultura
• Поведенческое Care as usual - resources only
  Families randomized to the control arm will receive FBP written resources, which the Guide (and interpreter, as needed) will review with them over \~5-15 minutes one time. This includes information on hospital services (e.g., cafeteria coupons), community resources (e.g., food and housing support), the structure and roles of the medical team, and the daily hospital schedule. Parents will be informed that their child's nurse is available to help them.

Первичные конечные точки

• System Navigation Ability [Срок оценки: Enrollment and 2-6 weeks after discharge]
• Pediatric Transition Experience Measure (P-TEM) [Срок оценки: 2-6 weeks after discharge]

Вторичные конечные точки (9)

• Diagnosis Comprehension [Срок оценки: 2-6 weeks after discharge]
• Perceived Stress Scale [Срок оценки: 2-6 weeks after discharge]
• Observed Communication: utterances in which team offers information [Срок оценки: Day 1-5 of hospital admission]
• Observed Communication: utterances in which team offers supportive talk [Срок оценки: Day 1-5 of hospital admission]
• Observed Communication: utterances in which parent asks questions [Срок оценки: Day 1-5 of hospital admission]
• Observed Communication: utterances in which parent responds assertively [Срок оценки: Day 1-5 of hospital admission]
• Observed Communication: parent talk-time [Срок оценки: Day 1-5 of hospital admission]
• Observed Communication: global partnership rating [Срок оценки: Day 1-5 of hospital admission]
• 30-day readmissions [Срок оценки: 30 days after discharge from index hospital stay]

Критерии участия

Parents/guardians Inclusion Criteria:

• At least 18 years old; there is no maximum age;
• The legal guardian of an eligible child
• Prefer English, Spanish, Somali or Vietnamese for medical care

Children Inclusion Criteria:

• Under 18 years of age at enrollment; there is no minimum age
• Admitted to a general pediatric service at a participating hospital
• Have been admitted within the past 4 days
• Have public or no insurance (as a proxy for low income)

Parents/guardians Exclusion Criteria:

\- None

Children Exclusion Criteria:

• Not already be enrolled in long-term care coordination or patient services navigation
• Not have an admitting diagnosis that is primarily psychiatric (e.g., anorexia nervosa, suicide attempt)
• Not be admitted for suspicion for child abuse.

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

Организация здравоохранения

Центры проведения

США · 2 центра

• Children's Hospital of Philadelphia — Philadelphia
• Seattle Children's — Seattle

Идентификаторы

NCT: NCT06276621 · STUDY00003564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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