Project Summary

What is this research about?

Pediatric preventive care visits, known as “well-child care,” are critical to addressing social, developmental, behavioral, and health concerns prior to preschool entry. However, many families, particularly those who are low-income, may not have their preventive care needs met within the current limited structure of a well-child care visit. In particular, critical social needs, if unaddressed, can have significant negative impact on health and development. To ensure that children achieve optimal clinical outcomes from preventive care, an innovative model of well-child care, in partnership with clinics serving low-income families, was developed. Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a health coach (i.e., health educator) as part of the well-child care team to provide comprehensive and family-centered well-child care services, address concerns related to family social needs, and decrease reliance on the clinician as the sole provider of preventive care services.

A randomized controlled trial (n=251) of PARENT at two pediatric practices serving a low-income, predominately Latinx population demonstrated robust improvements in the receipt of preventive care services, experiences of care, and reduced emergency department visits. Despite these improvements, exploratory analyses suggested reduced effectiveness for Black families compared with Latinx families.

A larger trial among federally-qualified health centers (FQHCs) is now underway to assess effectiveness and efficiency of PARENT among low-income families in a cluster RCT of ten FQHC clinical sites. While the trial of PARENT at FQHCs is critical to understanding intervention impact, just 5% of the FQHC patient population is Black, and thus findings will not aid in understanding how the intervention can be adapted to meet the needs of low-income Black families that were identified in the initial RCT. Therefore, an essential element of adaptation of PARENT to other clinical sites is understanding the comparative effectiveness of a PARENT intervention that is adapted to and implemented in practices that serve a larger proportion of Black families, and its impact on preventive care services and healthcare utilization among Black families.

What will the researchers do?

To address these research questions, the study team will partner with Nationwide Children’s Hospital Primary Care Network—its 12 practices serve a patient population that is over 96% publicly insured, 50% Black, and 16% Latinx. The following Specific Aims will be addressed:

Aim 1: Adapt PARENT to meet the needs of a diverse, largely Black population of underserved families.

Aim 2: Determine the effect of adapted PARENT on receipt of nationally recommended, preventive care services, emergency department utilization, and parent experiences of care.

Aim 3: Determine whether the effectiveness of adapted PARENT differs by family-level factors.

Aim 4: Explore parents’ experiences in receiving adapted PARENT.

How will the research team do this?

Using a stepped wedge design, all 12 Nationwide Children’s practice sites begin in the control group, and then sequentially, in randomly assigned order and at regular intervals, join the intervention group, implementing PARENT for all well-visits, ages 0- 15 months.  Data will be collected  from the electronic health record and health plan on all eligible children ages 9-15 months, at each data collection period, which occur at 9-month intervals over a 5-year period, for all practices, representing either control or intervention data.

Who can the research Help?

This study will help parents, payers, and providers determine how well-child care should be delivered to enhance health equity. It will provide evidence on preventive care delivery intervention adaptation for Black families.

At A Glance

Design: Stepped Wedge Randomized Trial

Population: Medicaid-insured children ages 0-15 months at 12 pediatric practices

Comparators: PARENT is a team-based approach to well-child care that utilizes a health 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.

Our comparator is traditional well-child care, which follows national, preventive care guidelines, including structured and standardized developmental and social needs screening.

Outcomes: receipt of preventive care services, emergency department utilization, parent experiences of care

Timeframe: Children 9-15 months of age, exposed to intervention or control for a 9-month period. N=13,980

Stakeholders: Black parents, pediatric practice providers and staff, and payers for NCH-PCN clinical site

*Patient-Centered Economic Outcomes Funding Supplement 
This study received supplemental funding to build on existing PCORI-funded comparative clinical effectiveness research (CER) studies to improve the understanding of appropriate costs and other economic burdens that are meaningful and inclusive to patients, caregivers and other stakeholders.

Project Information

Tumaini Coker, MD, MBA
Seattle Children's Research Institute
$6,418,396

Key Dates

July 2022
April 2029
2022

Study Registration Information

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Last updated: October 18, 2023