Testing a Scalable Model For ACEs-Related Care Navigation

Testing a Scalable Model For ACEs-Related Care Navigation Via 211 Telephone-Based Services

The study is a randomized controlled trial of a telephone-based care coordination system for families who experienced Adverse Childhood Events (ACEs). The investigators will conduct the study in partnership with Kaiser Permanente School of Medicine (KPSOM) and 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 and services for families who screen positive for ACEs.

Study Overview

• Status: Completed
• Conditions: Child Development; Adverse Childhood Experiences
• Intervention / Treatment: Behavioral: Behavioral: Telephone-based ACEs care coordination

Detailed Description

The trial will enroll 200 children ages 0-11 years from the three FQHCs partner clinics, who screen positive for at least 1 ACE during their clinical encounter. The research study team will randomize children 1:1 into intervention (connection to 211LA for ACEs care coordination + usual care) or control (usual care alone).

Primary outcomes will include number of referrals to, eligibility for, and receipt of ACE-related services among intervention group participants compared to controls.

The investigators will measure these outcomes through parent reported data and 211LA data at baseline and 6 months after enrollment.

Expected findings include higher referral and service rates by six months after enrollment among intervention group participants.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorena Porras-Javier, MPH; Phone Number: 310 486-6543; Email: lporras@mednet.ucla.edu
• Study Contact Backup: Name: Rebecca Dudovitz, MD MSHS; Phone Number: (310) 794 8833; Email: RDudovitz@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• A patient in one of the three partner community clinic systems (ChapCare, Via Care and NEVHC)
• Child aged 0 - 11 years old
• Parent or legal guardian of child at least 18 years of age
• Comfortable completing a survey by interview in English or Spanish

Exclusion Criteria:

• Child or sibling already enrolled in this study
• Child or sibling enrolled in the AMP Child Development 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: Experimental Intervention + Usual Care; Intervention group families will receive usual care and they will be connected via telephone to 211LA.	Behavioral: Behavioral: Telephone-based ACEs care coordination; The 211LA care coordinator will use the agency's extensive resource directory to identify and provide appropriate referral recommendations to each family. In addition, they will develop a care coordination plan, noting these recommendations and plans for follow-up, to be provided to the family's clinical care provider. The coordinator will routinely follow-up with the family until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.
No Intervention: No Intervention: Usual Care; This group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referrals to ACEs-related services	The percentage of children who are referred to at least one ACEs-related service, as reported on the participant survey.	2-6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of ACEs-related services	The percentage of children who receive at least one ACEs-related service, as reported on the participant survey.	2-6 months after enrollment
Number of referrals received	The number of referrals made for ACEs-related services, as reported on the participant survey.	2-6 months after enrollment
Number of services received	The number of ACEs-related services received, as reported on the participant survey.	2-6 months after enrollment

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Kaiser Permanente School of Medicine
• Investigators: Principal Investigator: Rebecca Dudovitz, MD MSHS, University of California, Los Angeles (UCLA)

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): October 5, 2022
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Health Services Research; Care Coordination
• Other Study ID Numbers: 22-000405

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 lporras@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