A Parent Coach–Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

BACKGROUND The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care (WCC) that relies on a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. OBJECTIVE This study aims to evaluate the impact of PARENT using a cluster randomized controlled trial. METHODS This study tested the effectiveness of PARENT at 10 clinical sites in 2 federally qualified health centers in Tacoma, Washington, and Los Angeles, California. We conducted a cluster randomized controlled trial that included 916 families with children aged ≤12 months at the time of the baseline survey. Parents will be followed up at 6 and 12 months after enrollment. The Parent Coach, the main element of PARENT, provides anticipatory guidance, psychosocial screening and referral, developmental and behavioral surveillance, screening, and guidance at each WCC visit. The coach is supported by parent-focused previsit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical examination and any concerns that require a clinician’s attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. We will examine parent-reported quality of care (receipt of nationally recommended WCC services, family-centeredness of care, and parental experiences of care), and health care use (WCC, urgent care, emergency department, and hospitalizations), conduct a cost analysis, and conduct a separate time-motion study of clinician time allocation to assess efficiency. We will also collect data on exploratory measures of parent-and parenting-focused outcomes. Our primary outcomes were receipt of anticipatory guidance and emergency department use. RESULTS Participant recruitment began in March 2019. After recruitment, 6- and 12-month follow-up surveys will be completed. As of August 30, 2021, we enrolled a total of 916 participants. CONCLUSIONS This large pragmatic trial of PARENT in partnership with federally qualified health centers will assess its utility as an evidence-based and financially sustainable model for the delivery of preventive care services to children in low-income communities. CLINICALTRIAL ClinicalTrials.gov: NCT03797898; https://clinicaltrials.gov/ct2/show/NCT03797898 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27054