Family Bridge Program
- Conditions
- Healthcare InequitiesHealthcare System NavigationGeneral Pediatric Medical ConditionsPatient-provider Communication
- Interventions
- Behavioral: Care as usual - resources onlyBehavioral: Family Bridge Program
- Registration Number
- NCT06276621
- Lead Sponsor
- Seattle Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 728
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Care as Usual- Resources Only Care as usual - resources only - Family Bridge Program Family Bridge Program -
- Primary Outcome Measures
Name Time Method System Navigation Ability 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-upPediatric Transition Experience Measure (P-TEM) 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 Outcome Measures
Name Time Method Observed Communication: utterances in which team offers supportive talk One time, on day 2-5 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
Diagnosis Comprehension 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.
Perceived Stress Scale 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
Observed Communication: utterances in which team offers information One time, on day 2-5 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.
Observed Communication: global partnership rating One time, on day 2-5 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
Observed Communication: parent talk-time One time, on day 2-5 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
Observed Communication: utterances in which parent asks questions One time, on day 2-5 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
30-day readmissions 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
Observed Communication: utterances in which parent responds assertively One time, on day 2-5 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
Trial Locations
- Locations (2)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Children's
🇺🇸Seattle, Washington, United States