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.

backgroundAdverse childhood experiences (ACEs) are potentially traumatic events occurring before age 18, such as maltreatment or exposure to violence. ACE screening is increasingly recommended to prevent and address physical and mental health conditions associated with ACEs. To promote ACE screening uptake, the state of California issued the "ACEs Aware" policy that provides Medicaid reimbursement for ACE screening annually for child primary care visits. However, policy directives alone often do not translate into effective screening efforts and greater access to care. Few rigorous studies have developed and tested implementation strategies for ACE pediatric screening policies. This study will fill this gap by testing a multifaceted implementation strategy in partnership with a Federally Qualified Health Center (FQHC) system serving low-income families in Southern California to support the ACE Aware policy.

methodsWe will use Implementation Mapping, with study process and consideration of determinants and mechanisms guided by the EPIS framework, to co-create and refine an implementation strategy. The proposed strategy is comprised of online training videos, a customized algorithm and use of technology to improve workflow efficiency, implementation training to internal FQHC personnel, clinic support and coaching, and written implementation protocols. A hybrid type 2, stepped-wedge cluster randomized trial design with five primary care clinics will test whether a multifaceted implementation strategy improves (a) fidelity to the ACE screening protocol, (b) reach defined as the proportion of eligible children screened for ACEs, and (c) the impact of the ACE policy on child-level mental health referrals and symptom outcomes. The study will use mixed methods with data to include electronic health records, surveys, and interviews with clinic personnel and caregivers. DISCUSSION: This study is designed to increase the capacity of FQHCs' inner context to successfully implement an outer context-initiated ACE policy designed to benefit pediatric patients. It capitalizes on a rare opportunity to use a co-creation approach to develop, adapt, refine, and pilot test an implementation strategy to maximize the impact of a new state-wide policy intended to improve ACE assessment and subsequent care to improve child health, particularly those from underserved communities.

trial registrationTrial # NCT04916587  registered at ClinicalTrials.gov on June 4, 2021.