Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852392
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-04-13
Brief Title:
Comparing Two Models of Well-Child Care for Black Families
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Parent-focused Redesign for Encounters Newborns to Toddlers PARENT Trial Comparing Two Models of Well-Child Care for Black Families
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Parent-focused Redesign for Encounters Newborns to Toddlers PARENT is a team-based approach to care that utilizes a community health worker in a health educator role Parents Coach to provide many of the Well-Child Care WCC services that children and families should receive addresses specific needs faced by families in low-income communities and decreases reliance on the clinician as the primary provider of WCC services The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino Medicaid-insured populations The aims of this study are to 1 Adapt the PARENT intervention to meet the needs of a diverse largely Black population of underserved families 2 Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services emergency department utilization and parent experiences of care 3 Determine whether the effectiveness of adapted PARENT differs by family-level factors 4 Explore parents experiences in receiving adapted PARENT 5 Examine the economic impact of adapted PARENT from the parent stakeholder perspective 6 Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective and 7 Examine the economic impact of adapted PARENT on healthcare utilization from the perspectives of parents and families
This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model
This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model
Detailed Description:
Clinical Practice Redesign can lead to innovative systems that improve preventive care for racial and ethnic minority children in low-income communities Although several strategies to redesign the structure of Well-Child Care WCC have been proposed and studied there are few evidence-based comprehensive models that are financially sustainable alternatives to current WCC The Parent Focused Redesign for Encounters Infants to Toddlers PARENT is a comprehensive early childhood WCC delivery model designed to improve the delivery of WCC for infants and toddlers in low-income communities PARENT includes a community health worker as part of a team-based approach to WCC The Parents Coach partners with the clinician to independently provide comprehensive and family-centered care that includes anticipatory guidance social needs screening developmental screening and connection to needed community resources The Parents Coach reduces the reliance on a clinician as the sole primary provider of routine WCC services The intervention changes the structure of WCC by adding the Parents Coach to the team personnel and changing the process or provision of care which impacts the receipt of preventive care and thus health outcomes
In previous trials of PARENT among a predominately Latino population of Medicaid-insured children we have reported intervention effects of better parent experiences of care greater receipt of preventive care services and more effective utilization of care Although these trials were not powered for sub-analyses by race exploratory analyses indicate that while Black and Latino families had similar intervention effects for receipt of services Black families did not have the positive intervention effects on parent experiences of care or the reduction of emergency department ED visits that Latino families did Thus adaptation implementation and testing of PARENT in a trial with a large sample of Black families is needed to optimize outcomes for Black families PARENT will be adapted implemented and tested in clinics that serve a large proportion of low-income Black families providing findings to aid our understanding of how the intervention can be adapted to meet the needs of low-income Black families
The adapted intervention if found to be more effective than usual care in providing family-centered comprehensive preventive care services to families has the potential to be implemented and disseminated to other clinical settings that serve a large proportion of children in low-income areas However our stakeholders for early childhood WCC will require additional information on family-centered economic outcomes to make decisions regarding the implementation and dissemination of this new model for early childhood preventive care To address this need we will examine patient-centered economic outcomes during the stepped wedge trial of the adapted intervention that will provide additional information to help WCC stakeholders make decisions about the delivery of care for early childhood WCC services
The study team will collaborate with investigators at Nationwide Childrens Hospital Primary Care Network NCH-PCN to conduct this study NCH-PCN is one of the largest Childrens Hospital owned primary care networks in the country Its 12 practices serve a patient population that is over 96 publicly insured 50 Black and 16 Latino Collaboration on this study represents a unique opportunity to meet a clinical need at NCH-PCN and address key research questions of PARENT adaptation implementation and impact for Black families
The study will conducted using a stepped wedge randomized trial design in order to evaluate the interventions effectiveness as well as its patient-centered economic outcomes
In previous trials of PARENT among a predominately Latino population of Medicaid-insured children we have reported intervention effects of better parent experiences of care greater receipt of preventive care services and more effective utilization of care Although these trials were not powered for sub-analyses by race exploratory analyses indicate that while Black and Latino families had similar intervention effects for receipt of services Black families did not have the positive intervention effects on parent experiences of care or the reduction of emergency department ED visits that Latino families did Thus adaptation implementation and testing of PARENT in a trial with a large sample of Black families is needed to optimize outcomes for Black families PARENT will be adapted implemented and tested in clinics that serve a large proportion of low-income Black families providing findings to aid our understanding of how the intervention can be adapted to meet the needs of low-income Black families
The adapted intervention if found to be more effective than usual care in providing family-centered comprehensive preventive care services to families has the potential to be implemented and disseminated to other clinical settings that serve a large proportion of children in low-income areas However our stakeholders for early childhood WCC will require additional information on family-centered economic outcomes to make decisions regarding the implementation and dissemination of this new model for early childhood preventive care To address this need we will examine patient-centered economic outcomes during the stepped wedge trial of the adapted intervention that will provide additional information to help WCC stakeholders make decisions about the delivery of care for early childhood WCC services
The study team will collaborate with investigators at Nationwide Childrens Hospital Primary Care Network NCH-PCN to conduct this study NCH-PCN is one of the largest Childrens Hospital owned primary care networks in the country Its 12 practices serve a patient population that is over 96 publicly insured 50 Black and 16 Latino Collaboration on this study represents a unique opportunity to meet a clinical need at NCH-PCN and address key research questions of PARENT adaptation implementation and impact for Black families
The study will conducted using a stepped wedge randomized trial design in order to evaluate the interventions effectiveness as well as its patient-centered economic outcomes
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