Clinical Trials Directory

Trials / Completed

CompletedNCT04916587

Implementation of Adverse Childhood Experiences (ACEs) Policy

Supporting the Implementation of a State Policy on Screening for Adverse Childhood Experiences (ACEs) in Federally Qualified Health Centers (FQHC)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
7,645 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
0 Years – 5 Years
Healthy volunteers
Accepted

Summary

Adverse Childhood Experiences (ACEs) are pervasive among children with 45% experiencing at least one ACE and 10% experiencing three or more, placing them at high risk for toxic stress and symptomatology. Yet, ACEs often go undetected in primary care settings during well-child visits due to unclear policies and tested implementation strategies. This pilot study will use mapping methodology, guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, to refine a multi-faceted strategy supporting the implementation of the state of California's 2020 policy promoting universal ACE screening in community clinics, and a stepped-wedge trial to test the impact of the strategy on implementation and child-level outcomes.

Detailed description

Adverse Childhood Experiences (ACEs) are defined as traumatic events occurring before age 18, such as maltreatment, life-threatening accident, harsh migration experiences or exposure to violence. ACEs are pervasive, with 45% experiencing at least one ACE and 10% experiencing three or more ACEs, placing them at high risk for negative life outcomes. ACEs are more prevalent among minority and immigrant communities due to exposure to poverty, discrimination, community violence, national disasters, and refugee experiences. ACEs screenings have potential value in identifying children experiencing toxic stress and the physical and mental health conditions associated with it such as asthma, Attention Deficit Hyperactive Disorder (ADHD) and anxiety. Yet, they are seldom used in primary care during well-child visits. The Surgeon General of the state of California have addressed this care gap by issuing an ACEs screening policy. Starting January 2020, MediCal, California's Medicaid health care program, will reimburse primary care settings ($29) for using the Pediatric ACEs and Related Life-events Screener (PEARLS) tool to screen children for ACEs during wellness visits. Despite significant investment in California and nationwide, evidence of the public health value of universal child screening policies is unclear. Increased screening efforts often do not translate into higher access to care for children and may even exacerbate disparities by increasing stigma and reinforcing a deficit view of marginalized groups. These results have been attributed to a lack of rigorous studies testing implementation strategies suited for pediatric screening policies. This mixed-method study will fill this gap by refining and testing an implementation strategy using a multi-site controlled trial within a Federally Qualified Health Center in Southern California. \[Update 05/2024\] Using the EPIS framework, we will employ a hybrid (type 2), controlled trial using a stepped-wedge design (n=5 clinics; 3 in the study and 2 clinics already implementing ACEs and used as comparison sites) to test the central hypothesis that clinics employing a multifaceted implementation strategy will have higher fidelity and reach of the ACEs screening policy. The partner FQHC system experienced financial strain during the COVID-19 pandemic and several of the randomly selected clinics closed prior to randomization.Selection of replacement clinics was based on clinic capacity to participate in the trial. Secondary hypothesis: impact of the ACEs policy on child mental health service and symptom outcomes. Aims are: 1. Refine a multifaceted implementation strategy to support the implementation of the ACEs screening policy in community-based clinics, and 2. Pilot test the feasibility, acceptability, fidelity and reach of the implementation strategy and the impact of the ACEs policy on child patient-level outcomes. This project capitalizes on a rare opportunity to pilot test an implementation strategy to maximize the impact of a state-wide policy intended to improve child health in under-resourced settings.

Conditions

Interventions

TypeNameDescription
OTHERImplementation Strategy of ACEs ScreeningsWe will use implementation mapping, guided by the EPIS framework, to promote a co-created process and refine the strategy comprised of online training videos, a customized ACEs algorithm and use of technology to improve workflow efficiency, implementation technical assistance/coaching, and written implementation protocols.
OTHERUsual CareThe ACEs Aware policy goal is to "equip providers with training and clinical protocols to screen children and adults for ACEs, detect ACEs early, and connect patients to interventions, resources, and other support to improve patient health and well-being." ACEs screenings are comprised of: a) a 2-hour on-line provider training; b) the Pediatric ACEs and Related Life-events Screener or PEARLS tool; c) an ACEs associated health conditions checklist; and d) complete a wellness exam. The primary care provider uses multiple sources of information to identify a child's need for follow-up services.

Timeline

Start date
2022-02-21
Primary completion
2024-04-30
Completion
2024-04-30
First posted
2021-06-07
Last updated
2025-07-20
Results posted
2025-05-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04916587. Inclusion in this directory is not an endorsement.