Comparing Two Models of Well-Child Care for Black Families

NCT05852392 | Recruiting

• 1 other identifier: STUDY00004147
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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 ("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, (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.

Conditions

Pediatric; Well Child Care

Keywords

Community Health Workers; Well Child Care; Black Children; Black Families; Preventive Care; Early Childhood; Patient-centered economic outcomes

Outcome Measures

Primary Outcomes (3)

• 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

• Healthcare Utilization

  Emergency department visits

  Every 9 months, up to 5 years

• Parent Experiences of Care

  Family-Centeredness Measure

  Every 9 months, up to 5 years

Secondary Outcomes (3)

• Receipt of additional preventive care services

  Every 9 months, up to 5 years

• Other Healthcare Utilization

  Every 9 months, up to 5 years

• "At-risk" for developmental delay

  Every 9 months, up to 5 years

Other Outcomes (5)

• Provider-parent visit time

  Every 9 months, up to 5 years

• Coach-parent visit time

  Every 9 months, up to 5 years

• Registered Nurse/Medical Assistant (RN/MA)-parent visit time

  Every 9 months, up to 5 years

Study Arms (2)

Adapted PARENT Model

EXPERIMENTAL

PARENT is a team-based approach to care that utilizes a community health worker (called a "coach") as part of the WCC team to provide comprehensive and family-centered preventive care services, address concerns related to family social needs, and decrease reliance on the clinician as the sole provider of preventive care services. The coach independently meets with the family at every early childhood well-child care visit to provide anticipatory guidance, social needs screening, developmental screening, and connection to needed community resources. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention. Practices will implement the adapted PARENT model for all well-visits, newborn through 15 months of age, and have a 9-month implementation exposure period to ensure that children ≤15 months of age at the practice have received the intervention; thereafter the practices maintain the intervention.

Other: Adapted PARENT Model

Traditional Well-Child Care

NO INTERVENTION

Our comparator is traditional well-child care, which follows national preventive care guidelines including structured and standardized developmental and social needs screening, and is in widespread use. These are well-child care visits led by the primary care clinician without a community health worker. All NCH-PCN practices will start in the control group, and then sequentially (by random assignment) move to become intervention.

Interventions

Adapted PARENT Model OTHER

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.

Adapted PARENT Model

Eligibility Criteria

• Age: 9 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• are age ≥9 and ≤15 months on day of data collection,
• have ≥1 visit at the practice in previous 9 months
• are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN

You may not qualify if:

• N/A

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Nationwide Children's Hospital: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Seattle Children's Research Institute

Seattle, Washington, 98104, United States

ACTIVE NOT RECRUITING

Related Links

• Patient-Centered Outcomes Research Institute (PCORI): Comparing Two Models of Well-Child Care for Black Families

Study Officials

• Tumaini Coker, MD, MBA

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teah Hoopes, MPH

CONTACT

206-884-4255; teah.hoopes@seattlechildrens.org

Tumaini Coker, MD, MBA

CONTACT

206-884-0559; tumaini.coker@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, General Pediatrics

Model Details: We will use a stepped wedge design, in which each of 12 clinical practice site starts in the control group, and then sequentially (by random assignment) moves to become intervention. Under "enrollment" below, we list the number of clinics to be randomized, as individual participants are not randomized or enrolled.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 10, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)