Implementation of Adverse Childhood Experiences (ACEs) Policy

Study Overview
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Brief Summary
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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
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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. Using the EPIS framework, we will employ a hybrid (type 2), randomized controlled trial using a stepped-wedge design (n=5 clinics) to test to test THE central hypothesis that clinics employing a multifaceted implementation strategy will have higher fidelity and reach of the ACEs screening policy. A secondary hypothesis will examine the public health impact of the ACEs policy on child patient-level mental health service and symptom outcomes. Specific aims are: Aim 1. Refine a multifaceted implementation strategy to support the implementation of the ACEs screening policy in community-based clinics, and Aim 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.

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

Conditions
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Adverse Childhood Experiences

Intervention / Treatment
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* Other: Implementation Strategy of ACEs Screenings
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: We will conduct a stepped wedge, cluster randomized pragmatic trial without transition periods. Five clinics (clusters) will receive the intervention at different points in time and following a random order. The full trial will last 15 months, conducted in six 10-week time periods. Control status refers to clinics following the ACEs state requirements (i.e., PEARLS screenings, ACEs health related condition checklist, wellness exam and follow up education). Intervention status refers to clinics experiencing the implementation strategies in addition to the state required ACEs process. During the baseline period (weeks 1-10), we will collect pre-implementation data on PEARLS screening rates, ACEs-related health conditions checklist, mental health referrals and child socio-demographics across clinics. Following baseline, five clinics will receive the intervention at five separate steps, following a random order. Outcomes will be collected in week 10/each step.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multifaceted Implementation Strategy<br>The core implementation strategy components are: 1) short video-trainings for clinic personnel (care team staff and providers) on the administration of caregiver-reported screening tools; 2) technical implementation support using an approach comprised of external academic consultants, and internal FQHC personnel to increase inner context capacity, 3) use of a validated clinical screening tool - Pediatric Symptoms Checklist (PSC-17), used in pediatric primary care settings to assess behavioral and social/emotional development. For this study, we will 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 tools is needed as the PEARLS only assesses ACEs exposure and not mental health symptomatology; and 4) use of a technology based tailored ACEs algorithm that incorporates multiple data sources. | Other: Implementation Strategy of ACEs Screenings<br>* We 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.<br>|
| Other: ACEs Screening<br>Adverse Childhood Experiences (ACEs) are potentially traumatic events occurring before age 18, such as maltreatment, harsh migration experiences or exposure to violence. ACEs screening are increasingly recommended to prevent and address physical and mental health conditions associated with ACEs. To promote ACEs screening uptake, the state of California issued the ACEs Aware 2020 policy; a fee-for-service health policy that provides a financial incentive to Medicaid-serving clinics to promote yearly 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. | Other: Usual Care<br>* The 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.<br>* Other names: ACEs Screenings;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of the intervention | proportion of eligible children screened for ACEs | 7.5 months | 
| Feasibility of the intervention and strategy | Participants perceive the ACEs policy and implementation strategy as feasible in their clinic | 7.5 months | 
| Acceptability of the intervention and strategy | Participants perceive the ACEs policy and implementation strategy as acceptable | 7.5 months | 
| Fidelity of the screening process | Adherence to screening protocols and competence of performance | 7.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health service referrals | Number of mental health referrals (behavioral analysis, behavioral health, care coordinator, care management, child development/development center or social work) divided by the total # of eligible children in a 10-week trial period. | 7.5 months | 
| Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC) | Mean score differences from eligible child visits in each 10-week period. Compare those means in pre vs post implementation periods. No threshold as we will test a two-tail hypothesis for this measure given mixed evidence on the impact of screening policies on access to care and clinical outcomes | 7.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Well-child screening, Implementation science