Actively Recruiting

Phase Not Applicable
Age: 9Months - 15Months
All Genders
Healthy Volunteers
NCT05852392

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

Led by Seattle Children's Hospital · Updated on 2026-05-07

12

Participants Needed

3

Research Sites

283 weeks

Total Duration

On this page

Sponsors

S

Seattle Children's Hospital

Lead Sponsor

N

Nationwide Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 9Months - 15Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 9 to 15 months on the day of data collection
  • At least one visit to the participating practice within the past 9 months
  • Insured by Partners for Kids, the Accountable Care Organization for NCH-PCN
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Hawaii Pacific Health

Honolulu, Hawaii, United States, 96826

Active, Not Recruiting

2

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

3

Seattle Children's Research Institute

Seattle, Washington, United States, 98104

Active, Not Recruiting

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Research Team

T

Teah Hoopes, MPH

CONTACT

T

Tumaini Coker, MD, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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