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

NCT05852392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Hawaii Pacific Health

    collaborator OTHER
  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Tumaini Coker, MD, MBA · Hawaii Pacific Health

  • Alice Ellyson, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
9 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2028-09-30
Completion
2028-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852392 on ClinicalTrials.gov