Implementation of Adverse Childhood Experiences (ACEs) Policy

Adverse Childhood Experiences Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916587
• Other study ID #: 22-0547
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: Monica Perez Jolles, PhD
• Phone: 303-724-0829
• Email: MONICA.JOLLES[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1342
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Childhood Experiences

Intervention

Other:
• Implementation Strategy of ACEs Screenings
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.
• Usual Care
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.

Locations

Country	Name	City	State
United States	Borrego Health	Desert Hot Springs	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of the intervention	proportion of eligible children screened for ACEs	7.5 months
Primary	Feasibility of the intervention and strategy	Participants perceive the ACEs policy and implementation strategy as feasible in their clinic	7.5 months
Primary	Acceptability of the intervention and strategy	Participants perceive the ACEs policy and implementation strategy as acceptable	7.5 months
Primary	Fidelity of the screening process	Adherence to screening protocols and competence of performance	7.5 months
Secondary	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
Secondary	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