Family Bridge Program

NCT06276621 | Enrolling By Invitation

• 1 other identifier: STUDY00003564
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 2

Brief 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 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, 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 from families who identify as Hispanic, Black, Asian, Native American/Alaska Native, or Pacific Islander. 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.

Conditions

Healthcare Inequities; General Pediatric Medical Conditions; Healthcare System Navigation; Patient-provider Communication

Outcome Measures

Primary Outcomes (2)

• System Navigation Ability

  Change score -100 to 100, based on 10-item measure of parent self-reported ability to navigate the healthcare system (e.g., ability to schedule appointments or ask questions). Each response of Yes (100), Sometimes (50), or No (0) is averaged to create overall score. Change score as difference from enrollment to follow-up

  Enrollment and 2-6 weeks after discharge

• Pediatric Transition Experience Measure (P-TEM)

  Percent of items with "top-box" score, based on the Pediatric Transition Experience Measure (P-TEM), an 8-item measure to assess hospital-to-home transition. Responses are on Likert scale from 0 to 5, with top-box scoring for overall measure.

  2-6 weeks after discharge

Secondary Outcomes (9)

• Diagnosis Comprehension

  2-6 weeks after discharge

• Perceived Stress Scale

  2-6 weeks after discharge

• Observed Communication: utterances in which team offers information

  Day 1-5 of hospital admission

• Observed Communication: utterances in which team offers supportive talk

  Day 1-5 of hospital admission

• Observed Communication: utterances in which parent asks questions

  Day 1-5 of hospital admission

Study Arms (2)

Family Bridge Program

EXPERIMENTAL

Behavioral: Family Bridge Program

Care as Usual- Resources Only

ACTIVE COMPARATOR

Behavioral: Care as usual - resources only

Interventions

Family Bridge Program BEHAVIORAL

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 cultural beliefs), which is communicated to the medical team and documented in the electronic health record;(4)communication coaching for parents/caregivers to help them clarify and practice asking questions of the medical team; (5)emotional support via daily check-ins during the hospital stay; (6)assistance with logistics ; and (7)one follow-up phone call, 2 days post-discharge, to address remaining questions and connect families to ongoing services if needed.

Family Bridge Program

Care as usual - resources only BEHAVIORAL

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.

Care as Usual- Resources Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• Have a self- or parent-reported race/ethnicity other than only non-Hispanic white

You may not qualify if:

• \- None
• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 26, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (2)