Implementation of Adverse Childhood Experiences (ACEs) Policy

Not Applicable

Completed

Conditions: Adverse Childhood Experiences

Registration Number: NCT04916587

Lead Sponsor: University of Colorado, Denver

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7645

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
ACEs Screenings Reach	Every 10 weeks during the study trial, up to 19 months	The number of participants with ACEs screenings.
Mental Health Service Referral	Every 10 weeks during the study trial, up to 19 months.	Number of participants with a mental health referral (behavioral analysis, behavioral health, care coordinator, care management, child development/development center or social work)

Secondary Outcome Measures

Name	Time	Method
Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)	First score measure during ACEs screenings. Follow-up scores from 8 - 16 months	The percentage of children screening positive for BPSS or PPSC from the time of the ACEs screening. These data were collected on a subsample of study participants during ACEs screenings (n=414). From that group, a total of 50 caregivers provided follow up information on PSC scores (n=50). This secondary outcome was collected as part of the strategy in the intervention group only (i.e., ACEs screenings plus the multifaceted implementation strategy group). The data were only collected from the "ACEs Screenings and a Multifaceted Implementation Strategy" Arm/Group.
Acceptability of the Strategy	End of data collection -End of period 7 in the stepped-wedge schedule	Self-reported 4-item instrument to evaluate acceptability of ACEs policy and implementation efforts. 4-pt Likert scale; average score of 4+ shows acceptability. Good internal consistency (α=0.83). Test-retest reliability r=0.83. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the acceptability of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites.
Feasibility of the Strategy	End of data collection- End of Period 7 based on the Stepped-Wedge Schedule	Self-reported 4-item instrument to evaluate the feasibility of implementation efforts. 4-pt Likert scale; average score of 4+ shows ACEs policy and implementation strategy perceived as feasible. Good internal consistency (α=0.89). Test-retest reliability r=0.88. At the end of the stepped-wedge schedule, clinical personnel were invited to participate in a survey to evaluate the feasibility of the strategy. These data were collected on a subsample of clinic personnel involved in the implementation of the ACEs screenings at the study clinical sites.