protocolSection identificationModule nctId: NCT06276621, orgStudyIdInfo id: STUDY00003564, briefTitle: Family Bridge Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Children's Hospital of Philadelphia, descriptionModule briefSummary: Pediatric healthcare inequities 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 demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities 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 diverse 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 of color, 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 of color. 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 for families of low-income children of color; (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 of color, including those who prefer a language other than English for their medical care., conditionsModule conditions: Healthcare Inequities, conditions: General Pediatric Medical Conditions, conditions: Healthcare System Navigation, conditions: Patient-provider Communication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 728, type: ESTIMATED, armsInterventionsModule interventions name: Family Bridge Program, interventions name: Care as usual - resources only, outcomesModule primaryOutcomes measure: System Navigation Ability, primaryOutcomes measure: Pediatric Transition Experience Measure (P-TEM), secondaryOutcomes measure: Diagnosis Comprehension, secondaryOutcomes measure: Perceived Stress Scale, secondaryOutcomes measure: Observed Communication: utterances in which team offers information, secondaryOutcomes measure: Observed Communication: utterances in which team offers supportive talk, secondaryOutcomes measure: Observed Communication: utterances in which parent asks questions, secondaryOutcomes measure: Observed Communication: utterances in which parent responds assertively, secondaryOutcomes measure: Observed Communication: parent talk-time, secondaryOutcomes measure: Observed Communication: global partnership rating, secondaryOutcomes measure: 30-day readmissions, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False