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Enrolling By Invitation NCT06276621

Family Bridge Program

Conditions: General Pediatric Medical Conditions, Healthcare System Navigation, Patient-provider Communication, Health Disparities

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 728
Sponsor: Seattle Children's Hospital

Location: Children's Hospital of Philadelphia Philadelphia Pennsylvania

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06276621). StuddyBuddy aggregates publicly available trial information.