Family Bridge Program

Patient-provider Communication Clinical Trial

Official title:

Family Bridge Program Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276621
• Other study ID #: STUDY00003564
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 2026

Study information

• Verified date: February 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 728
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient-provider Communication

Intervention

Behavioral:
• Family Bridge Program
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Children's Hospital of Philadelphia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Diagnosis Comprehension	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.	2-6 weeks after discharge
Secondary	Perceived Stress Scale	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	2-6 weeks after discharge
Secondary	Observed Communication: utterances in which team offers information	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.	One time, on day 2-5 of hospital admission
Secondary	Observed Communication: utterances in which team offers supportive talk	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	One time, on day 2-5 of hospital admission
Secondary	Observed Communication: utterances in which parent asks questions	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	One time, on day 2-5 of hospital admission
Secondary	Observed Communication: utterances in which parent responds assertively	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	One time, on day 2-5 of hospital admission
Secondary	Observed Communication: parent talk-time	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	One time, on day 2-5 of hospital admission
Secondary	Observed Communication: global partnership rating	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	One time, on day 2-5 of hospital admission
Secondary	30-day readmissions	Readmissions to observation or inpatient status at the same hospital within 30 days of discharge from the index hospital stay	30 days after discharge from index hospital stay