Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System (AMP)

A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

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.

Study Overview

• Status: Completed
• Conditions: Child Development; Health Services Research
• Intervention / Treatment: Behavioral: Telephone-based early childhood developmental care coordination

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.

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90011
      • South Central Family Health Center
    • Los Angeles, California, United States, 90022
      • Via Care
    • Pasadena, California, United States, 91103
      • ChapCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 months to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention + Usual Care + Developmental Screening Results; Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention.	Behavioral: Telephone-based early childhood developmental care coordination; The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.
No Intervention: Usual Care + Developmental Screening Results; This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral to, eligibility for, and receipt of early childhood developmental services 6 months after enrollment	The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, 2) the percentage of children who are deemed eligible for services by service organizations, and 3) the percentage of children who receive services.	6 months after enrollment
Child Developmental Outcomes	The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) will be used to determine developmental assessment scores. All children will receive the language sub-scale of this instrument, and those children who screened positive (at high or moderate risk on the PEDS Online) will receive the full assessment.	Change in child developmental assessment score between baseline and 24 months after enrollment
Intervention Cost / Benefit Analysis	Intervention costs per child screened are composed of the 211LA program costs for care coordination and the costs of services received. Intervention benefits are the long-term benefits of service receipt in terms of potential changes in employment, income, crime, and life expectancy.	24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of referrals, number of children eligible for services, and number of children who have received services	The secondary outcome will be assessed by the average number of 1) referrals made, 2) services for which children are deemed eligible, and 3) services received for each family; the investigators will primarily consider referrals to high-level intervention services for developmental and behavioral problems, but will also track referrals to development-related preventive and support services.	6 months after enrollment

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Virginia Commonwealth University; Kaiser Permanente School of Medicine; Information and Referral Federation of Los Angeles County (211 LA County)
• Investigators: Principal Investigator: Paul J Chung, MD MS, Kaiser Permanente School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: care coordination; early childhood development; developmental screening
• Other Study ID Numbers: 19-001556; 7R01HD092406-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be shared.
• IPD Sharing Time Frame: Data will be shared within 2 years of study completion.
• IPD Sharing Access Criteria: Proposals should be directed to lindseythompson@mednet.ucla.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be provided when requests are approved.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No