Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care Services

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Seattle Children's Hospital
Study ID
NCT05852392
Status
Recruiting
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Conditions

  • Pediatric
  • Well Child Care

Eligibility Criteria

Sex
ALL
Age
9 Months - 15 Months
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Adapted PARENT Model
    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.
  • No Intervention: Traditional Well-Child Care
    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.

Primary Outcome Measure

Receipt of preventive care services [ Time Frame: Every 9 months, up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Hawaii Pacific HealthHonoluluHawaii96826-
Nationwide Children's HospitalColumbusOhio43205
Alex Kemper, MD, MPH, MS
[email protected]
614-355-3605
Alex Kemper, MD, MPH, MS (PRINCIPAL_INVESTIGATOR)
Seattle Children's Research InstituteSeattleWashington98104-

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By research site
Hawaii Pacific Health· Honolulu, HINationwide Children's Hospital· Columbus, OHSeattle Children's Research Institute· Seattle, WA

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