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
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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