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Enrolling by Invitation

NCT Number: NCT06276621

Family Bridge Program

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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. System Navigation Ability

    Time frame: Enrollment and 2-6 weeks after discharge

    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

  2. Pediatric Transition Experience Measure (P-TEM)

    Time frame: 2-6 weeks after discharge

    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.

Secondary outcomes

  1. Diagnosis Comprehension

    Time frame: 2-6 weeks after discharge

    Discharge diagnosis concordance: 2 nurse coders, blinded to study arm, will code parent-reported discharge diagnosis as (2) Correct, (1) Vague/Incomplete, or (0) Wrong/not concordant, by comparing it to diagnosis abstracted from discharge summary, using standard of whether a follow-up provider would know the diagnosis based on the parent-provided information; dichotomized for analysis.

  2. Perceived Stress Scale

    Time frame: 2-6 weeks after discharge

    Scale score 0-16, using Perceived Stress Scale-Short Form 4-item measure; higher score indicates greater global stress and lower perceived control over it

  3. Observed Communication: utterances in which team offers information

    Time frame: Day 1-5 of hospital admission

    Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a member of the medical team made an utterance that exchanged information with the family.

  4. Observed Communication: utterances in which team offers supportive talk

    Time frame: Day 1-5 of hospital admission

    Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a member of the medical team made an utterance that was directly supportive of family

  5. Observed Communication: utterances in which parent asks questions

    Time frame: Day 1-5 of hospital admission

    Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a parent or caregiver asks a question

  6. Observed Communication: utterances in which parent responds assertively

    Time frame: Day 1-5 of hospital admission

    Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a parent or caregiver responds to something a member of the medical team says in an assertive manner

  7. Observed Communication: parent talk-time

    Time frame: Day 1-5 of hospital admission

    Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting the percent of the overall discussion time during which the parent or caregiver was speaking

  8. Observed Communication: global partnership rating

    Time frame: Day 1-5 of hospital admission

    Likert scale rating from 1-5 of audio-recorded communication with the medical team (on family centered rounds or similar discussion), rating the overall degree of partnership between family and medical team demonstrated during the discussion

  9. 30-day readmissions

    Time frame: 30 days after discharge from index hospital stay

    Readmissions to observation or inpatient status at the same hospital within 30 days of discharge from the index hospital stay

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

Family Bridge Program Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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