NCT05852392 Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care Services
| NCT ID | NCT05852392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Children's Hospital |
| Condition | Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2023-06-30 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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: 1. are age ≥9 and ≤15 months on day of data collection, 2. have ≥1 visit at the practice in previous 9 months 3. are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN Exclusion Criteria: * N/A
Contact & Investigator
Tumaini Coker, MD, MBA
PRINCIPAL INVESTIGATOR
Hawaii Pacific Health
Frequently Asked Questions
Who can join the NCT05852392 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 15 Months, studying Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05852392 currently recruiting?
Yes, NCT05852392 is actively recruiting participants. Contact the research team at teah.hoopes@seattlechildrens.org for enrollment information.
Where is the NCT05852392 trial being conducted?
This trial is being conducted at Honolulu, United States, Columbus, United States, Seattle, United States.
Who is sponsoring the NCT05852392 clinical trial?
NCT05852392 is sponsored by Seattle Children's Hospital. The principal investigator is Tumaini Coker, MD, MBA at Hawaii Pacific Health. The trial plans to enroll 12 participants.