Clinical trial NCT04118452: Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
Official title: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Health Services Research
Keywords: early childhood development
developmental screening
care coordination
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente School of Medicine
name: Virginia Commonwealth University
name: Information and Referral Federation of Los Angeles County (211 LA County)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-10-08
Enrollment: 565
Sex: ALL
Minimum age (years): 11
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.

Detailed description: The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).

Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.

Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.

Eligibility criteria: Inclusion Criteria:

* A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care)
* A patient with an upcoming one- to three-year old well child appointment scheduled
* Child aged 11-42 months

Exclusion Criteria:

* Parent who does not speak English or Spanish
* Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services.
* Child has a sibling already enrolled in the study.

Primary outcomes:
measure: Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment
timeFrame: 6 months after enrollment
measure: Child Developmental Outcomes
timeFrame: Baseline and 24 months after enrollment
Secondary outcomes:
measure: Number of Children Who Have Received Referrals and Number of Children Who Have Received Services
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: South Central Family Health Center
state: California
city: Los Angeles
country: United States
facility: Via Care
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Pasadena
country: United States
facility: ChapCare
state: California
Study officials:
affiliation: Kaiser Permanente School of Medicine
name: Paul J Chung, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson BB, Thompson LR, Herrera P, Biely C, Arriola Zarate D, Aceves I, Estrada I, Chan V, Orantes C, Chung PJ. Telephone-Based Developmental Screening and Care Coordination Through 2-1-1: A Randomized Trial. Pediatrics. 2019 Apr;143(4):e20181064. doi: 10.1542/peds.2018-1064.