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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118452
Recruitment Status : Enrolling by invitation
First Posted : October 8, 2019
Last Update Posted : February 11, 2021
Sponsor:
Collaborators:
Kaiser Permanente School of Medicine
Virginia Commonwealth University
Information and Referral Federation of Los Angeles County (211 LA County)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Paul Chung, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Child Development Health Services Research Behavioral: Telephone-based early childhood developmental care coordination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 662 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

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.



Primary Outcome Measures :
  1. Referral to, eligibility for, and receipt of early childhood developmental services 6 months after enrollment [ Time Frame: 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.

  2. Child Developmental Outcomes [ Time Frame: Change in child developmental assessment score between baseline and 24 months after enrollment ]
    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.

  3. Intervention Cost / Benefit Analysis [ Time Frame: 24 months after enrollment ]
    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.


Secondary Outcome Measures :
  1. Number of referrals, number of children eligible for services, and number of children who have received services [ Time Frame: 6 months after enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118452


Locations
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United States, California
South Central Family Health Center
Los Angeles, California, United States, 90011
Via Care
Los Angeles, California, United States, 90022
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
ChapCare
Pasadena, California, United States, 91103
Sponsors and Collaborators
University of California, Los Angeles
Kaiser Permanente School of Medicine
Virginia Commonwealth University
Information and Referral Federation of Los Angeles County (211 LA County)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Paul J Chung, MD MS Kaiser Permanente School of Medicine
Publications:
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Responsible Party: Paul Chung, Adjunct Professor of Pediatrics and Health Policy & Management, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04118452    
Other Study ID Numbers: 19-001556
7R01HD092406-02 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared within 2 years of study completion.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Chung, University of California, Los Angeles:
early childhood development
developmental screening
care coordination