Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276621
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-26
First Post:
2024-02-05
Brief Title:
Family Bridge Program
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Family Bridge Program Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 familys 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 parentscaregivers 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 eg 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 11 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
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 eg 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 11 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None