Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care

NCT03797898 | Completed Results

• 2 other identifiers: STUDY000004135R01HD088586
• Study Type: interventional
• Target: 937
• Locations: 1 country
• Sites: 2

Brief Summary

Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using 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. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam 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. The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.

Conditions

Preventive Health Services; Health Promotion

Outcome Measures

Primary Outcomes (2)

• Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits

  Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better

  12 months post enrollment

• Healthcare Utilization: Emergency Department Utilization

  any emergency department care visit for the index child in past 12 months (parent report)

  12 months post enrollment

Secondary Outcomes (7)

• Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit

  Data not collected due to COVID Pandemic restrictions on in clinic observations.

• Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits

  12 months post enrollment

• Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.

  12 months post enrollment

• Healthcare Utilization: Hospitalizations

  12 months post enrollment

• Healthcare Utilization: Well Child Care Visits Up to Date

  12 months post enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).

Other: Parent Coach

Control

NO INTERVENTION

usual care well child care

Interventions

Parent Coach OTHER

The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit.
• Parent is English or Spanish proficient
• For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.

You may not qualify if:

• More than one child attending Well-Child Care
• Legal guardian of child is under 18 years of age
• Parents who are employed by one of the federally-qualified health centers (FQHCs)
• Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

Location

Related Publications (7)

• Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14.

  PMID: 28232142 BACKGROUND

• Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.

  PMID: 26908675 BACKGROUND

• Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.

  PMID: 23457149 BACKGROUND

• Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.

  PMID: 24936004 BACKGROUND

• Coker TR, Lowry SJ, Dwibedi E, Salaguinto T, Szilagyi PG, Fiscella K, Rangel SJ, Ortiz J, Weaver MR. Cost Analysis of the PARENT Trial of Community Health Workers in Early Childhood Preventive Care: A Secondary Analysis of a Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522732. doi: 10.1001/jamanetworkopen.2025.22732.

  PMID: 40742591 DERIVED

• Coker TR, Liljenquist K, Lowry SJ, Fiscella K, Weaver MR, Ortiz J, LaFontaine R, Silva J, Salaguinto T, Johnson G, Friesema L, Porras-Javier L, Guerra LJS, Szilagyi PG. Community Health Workers in Early Childhood Well-Child Care for Medicaid-Insured Children: A Randomized Clinical Trial. JAMA. 2023 May 23;329(20):1757-1767. doi: 10.1001/jama.2023.7197.

  PMID: 37120800 DERIVED

• Hurst R, Liljenquist K, Lowry SJ, Szilagyi PG, Fiscella KA, Weaver MR, Porras-Javier L, Ortiz J, Sotelo Guerra LJ, Coker TR. A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 25;10(11):e27054. doi: 10.2196/27054.

  PMID: 34842563 DERIVED

Results Point of Contact

• Title: Tumaini R. Coker, MD, MBA
• Organization: Seattle Children's

Tumaini.Coker@seattlechildrens.org

206-884-0559

Study Officials

• Tumaini R Coker, MD/MBA

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 9, 2019
• Study Start: March 5, 2019
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)