Clinical trial NCT03797898: Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care
Official title: Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Health Services
Health Promotion
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-01-09
Enrollment: 937
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.

A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities.

To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). 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 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.

To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics.

In preparation for the trial, investigators will use a Community Engagement \& Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits
timeFrame: 12 months post enrollment
measure: Healthcare Utilization: Emergency Department Utilization
timeFrame: 12 months post enrollment
Secondary outcomes:
measure: Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit
timeFrame: Data not collected due to COVID Pandemic restrictions on in clinic observations.
measure: Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits
timeFrame: 12 months post enrollment
measure: Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.
timeFrame: 12 months post enrollment
measure: Healthcare Utilization: Hospitalizations
timeFrame: 12 months post enrollment
measure: Healthcare Utilization: Well Child Care Visits Up to Date
timeFrame: 12 months post enrollment
measure: Experiences of Care: Helpfulness of Care Assessment by Parent Report
timeFrame: 12 months post enrollment
measure: Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
timeFrame: 12 months post enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Tumaini R Coker, MD/MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.