Implementation of Adverse Childhood Experiences (ACEs) Policy

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Adverse Childhood Experiences

Treatments: Other: Implementation Strategy of ACEs Screenings; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04916587

R21MH123835 (U.S. NIH Grant/Contract)

22-0547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,645 patients

Sex: All

Ages: Under 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children ages 0-5 scheduled for wellness visit for upcoming week
• Caregiver of child is 18 years or older with legal custody or authority to arrange care for child
• Caregiver provides informed consent; signs consent form and HIPAA release form as well as coronavirus disease (COVID-19) information sheet
• Caregiver agrees to complete the Pediatric Symptoms Checklist or PSC
• Caregiver provides permission for socio-demographic information about their child to be pulled from EMR records, de-identified, and shared with PI

Exclusion criteria

• Children ages 0-5 scheduled for wellness visit for upcoming week
• Caregiver declines to provide signed informed consent, HIPAA release, or permission for socio-demographic data to be pulled from the Electronic Medical Records (EMR), de-identified and shared with PI; or declines to respond to 17 questions for the PSC
• Children ages 6-18 scheduled for wellness visits
• Children ages 0-5 scheduled for wellness visits outside the study data collection windows or at clinics not providing pediatric care
• Caregiver does not have legal guardianship or written authority to arrange care for the child

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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7,645 participants in 2 patient groups

ACEs Screenings and a Multifaceted Implementation Strategy

Active Comparator group

Description:

\[Update May/2024\] ACEs pediatric screenings in primary care settings. This study will focus on screening children ages 0-5, in line with the partnering FQHC's ACEs screening priorities. The implementation strategy components are: 1) video-trainings for clinic personnel (care team staff and providers); 2) technical implementation support to increase inner context capacity, 3) use of a validated clinical screening tool - Pediatric Symptoms Checklist (PSC-17), used in pediatric settings to assess behavioral and social/emotional development. For this study, we use the PSC tools that are tailored to children ages 0 to 5 years old with the Baby Pediatric Symptomatology Checklist (BPSC) for ages 0 to 18 months, and the Preschool Pediatric Symptom Checklist (PPSC) for ages 18 to 60 months. This screening tool is needed as the PEARLS only assesses ACEs exposure; and 4) use of a technology-based tailored ACEs algorithm that incorporates multiple data sources.

Treatment:

Other: Implementation Strategy of ACEs Screenings

Standard Care

Other group

Description:

Clinics provide standard care that includes unstructured conversations between clinicians and caregivers about the child(ren)'s needs and a service referral as needed.

Treatment:

Other: Usual Care