Comparing Two Models of Well-Child Care for Black Families

Pediatric Clinical Trial

Official title:

Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) Trial: Comparing Two Models of Well-Child Care for Black Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852392
• Other study ID #: STUDY00004147
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2024
• Source: Seattle Children's Hospital
• Contact: Teah Hoopes, MPH
• Phone: 206-884-4255
• Email: teah.hoopes[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ("Parent's 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, and (4) Explore parents' experiences in receiving adapted PARENT.

This study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC.

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 "Parent's 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 Parent's 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 Parent's 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 study team will collaborate with investigators at Nationwide Children's Hospital Primary Care Network (NCH-PCN) to conduct this study. NCH-PCN is one of the largest Children's 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 intervention's effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 15 Months

Eligibility

Inclusion Criteria:

Participants are not individually recruited or enrolled; rather we collect de-identified Electronic Health Record (EHR) and administrative data on all children in the practices who:

1. are age =9 and =15 months on day of data collection,

2. have =1 visit at the practice in previous 9 months

3. are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Pediatric
• Well Child Care

Intervention

Other:
• Adapted PARENT Model
PARENT is a team-based approach to care that utilizes a clinic-based community health worker as part of the WCC team to provide comprehensive and family-centered preventive care services.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of preventive care services	Child and parent receipt of three key preventive care services: anticipatory guidance, social needs screening, and structured developmental screening	Every 9 months, up to 5 years
Primary	Healthcare Utilization	Emergency department visits	Every 9 months, up to 5 years
Primary	Parent Experiences of Care	Family-Centeredness Measure	Every 9 months, up to 5 years
Secondary	Receipt of additional preventive care services	Receipt of a) social needs referral (e.g., to a food bank), b) successful connection with social needs source (e.g., parent reports accessing food bank), c) developmental or behavioral referral (e.g., Early Intervention Center), and d) successful connection with developmental needs source (e.g., visit at Early Intervention completed).	Every 9 months, up to 5 years
Secondary	Other Healthcare Utilization	WCC and acute care visits, and hospitalizations	Every 9 months, up to 5 years
Secondary	"At-risk" for developmental delay	Identified as "at-risk" following developmental screening	Every 9 months, up to 5 years