Testing a Scalable Model For ACEs-Related Care Navigation

NCT ID: NCT05567250

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2023-11-24

Brief Summary

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.

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.

Conditions

Adverse Childhood Experiences; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental Intervention + Usual Care

Intervention group families will receive usual care and they will be connected via telephone to 211LA.

Group Type: EXPERIMENTAL

Behavioral: Telephone-based ACEs care coordination

Intervention Type: BEHAVIORAL

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: Usual Care

This group will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente School of Medicine

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Dudovitz, MD, MSHS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Dudovitz, MD MSHS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30894408 (View on PubMed)

Chang CL, Chung PJ, Ngan H, Porras-Javier L, Vangala S, Correa-Mendoza L, Calderon K, Thompson LR, Molina D, Aceves I, Torres F, Dudovitz R. Testing a Scalable Model for ACEs-Related Care Coordination via 211 Telephone-Based Services. Acad Pediatr. 2025 Oct 27:103160. doi: 10.1016/j.acap.2025.103160. Online ahead of print.

Reference Type: DERIVED

PMID: 41161485 (View on PubMed)

Other Identifiers

22-000405

Identifier Type: -

Identifier Source: org_study_id