Clinical trial NCT04916587: Implementation of Adverse Childhood Experiences (ACEs) Policy
Official title: Supporting the Implementation of a State Policy on Screening for Adverse Childhood Experiences (ACEs) in Federally Qualified Health Centers (FQHC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Childhood Experiences
Keywords: Well-child screening
Implementation science
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-06-07
Enrollment: 7645
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: \[Update May/2024\] We conduct a stepped wedge, cluster pragmatic trial without transition periods. Three clinics (clusters) receive the intervention at different points in time. The full trial lasts 18 months, conducted in seven extended 10-week periods. Control status refers to clinics following standard care. During the COVID-19 pandemic, clinics did not start ACEs screenings. Intervention status refers to clinics experiencing the implementation strategy and ACEs screenings. During baseline (weeks 1-10), we collect pre-implementation data on mental health referrals, and child socio-demographics. Following baseline, clinics receive the intervention in six steps. Outcomes collected in week 10/each step
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: ACEs Screenings Reach
timeFrame: Every 10 weeks during the study trial, up to 19 months
measure: Mental Health Service Referral
timeFrame: Every 10 weeks during the study trial, up to 19 months.
Secondary outcomes:
measure: Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)
timeFrame: First score measure during ACEs screenings. Follow-up scores from 8 - 16 months
measure: Acceptability of the Strategy
timeFrame: End of data collection -End of period 7 in the stepped-wedge schedule
measure: Feasibility of the Strategy
timeFrame: End of data collection- End of Period 7 based on the Stepped-Wedge Schedule
Other outcomes:
Locations:
city: Desert Hot Springs
country: United States
facility: Borrego Health
state: California
Study officials:
affiliation: University of Colorado, Denver
name: Monica Perez Jolles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez Jolles M, Mack WJ, Reaves C, Saldana L, Stadnick NA, Fernandez ME, Aarons GA. Using a participatory method to test a strategy supporting the implementation of a state policy on screening children for adverse childhood experiences (ACEs) in a Federally Qualified Health Center system: a stepped-wedge cluster randomized trial. Implement Sci Commun. 2021 Dec 20;2(1):143. doi: 10.1186/s43058-021-00244-4.