Clinical trial NCT06276621: Family Bridge Program
Official title: Family Bridge Program Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthcare Inequities
General Pediatric Medical Conditions
Healthcare System Navigation
Patient-provider Communication
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2024-02-26
Enrollment: 728
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


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)
* Have a self- or parent-reported race/ethnicity other than only non-Hispanic white (as a proxy for discrimination and its effects)

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.

Primary outcomes:
measure: System Navigation Ability
timeFrame: Enrollment and 2-6 weeks after discharge
measure: Pediatric Transition Experience Measure (P-TEM)
timeFrame: 2-6 weeks after discharge
Secondary outcomes:
measure: Diagnosis Comprehension
timeFrame: 2-6 weeks after discharge
measure: Perceived Stress Scale
timeFrame: 2-6 weeks after discharge
measure: Observed Communication: utterances in which team offers information
timeFrame: One time, on day 2-5 of hospital admission
measure: Observed Communication: utterances in which team offers supportive talk
timeFrame: One time, on day 2-5 of hospital admission
measure: Observed Communication: utterances in which parent asks questions
timeFrame: One time, on day 2-5 of hospital admission
measure: Observed Communication: utterances in which parent responds assertively
timeFrame: One time, on day 2-5 of hospital admission
measure: Observed Communication: parent talk-time
timeFrame: One time, on day 2-5 of hospital admission
measure: Observed Communication: global partnership rating
timeFrame: One time, on day 2-5 of hospital admission
measure: 30-day readmissions
timeFrame: 30 days after discharge from index hospital stay
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children&#39;s Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
References: