NCT06276621

Family Bridge Program

ENROLLING BY INVITATION NA Last updated 3 February 2026

What this trial tests

NA trial testing Family Bridge Program in Healthcare Inequities in 728 participants. Enrolling by invitation.

Timeline

7 May 2024

Primary endpoint
31 August 2026

31 October 2026

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	728
Start date	7 May 2024
Primary completion	31 August 2026
Estimated completion	31 October 2026
Sites	2 locations across United States

Drugs / interventions tested

• Family Bridge Program
• Care as usual - resources only

Conditions studied

• Healthcare Inequities — all drugs for Healthcare Inequities →
• General Pediatric Medical Conditions — all drugs for General Pediatric Medical Conditions →
• Healthcare System Navigation — all drugs for Healthcare System Navigation →
• Patient-provider Communication — all drugs for Patient-provider Communication →

Sponsor

Seattle Children's Hospital

Who can join

Eligibility, any sex, with Healthcare Inequities or General Pediatric Medical Conditions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.