Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial

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PROJECT SUMMARY/ABSTRACT Chronic care models (CCM) that deliver evidence-based practices (EBP) by multidisciplinary provider teams with primary care physicians (PCP) and behavioral health (BH) providers (as care managers, CM) have improved BH outcomes in adults1-3 and children/teens, but their widespread application is impeded by implementation barriers at multiple levels. As an example, our clinical trials document the benefits of a simplified cross-diagnosis CCM protocol for child behavior problems and ADHD (Doctor Office Collaborative Care; DOCC; MH064372), but DOCC requires targeted implementation support to enhance uptake and address practical barriers at the care team (e.g., low coordination) and practice/leadership levels (e.g., low priority). Further, meta-analyses suggest that science provides few answers for how to overcome such obstacles as trials have not tested implementation strategies to scale-up a pediatric CCM. As a theory-based implementation intervention, Facilitation delivered by an outside expert with providers/teams (external) or practice manager/leaders (internal) has enhanced provider competency to deliver an EBP and leadership or organizational-level commitment to EBP implementation. External facilitation strategies applied to a care team (TEAM) may engage validated targets (i.e., team functioning), whereas internal facilitation strategies applied to leaders (LEAD) may engage practice-level targets (i.e., implementation support) to enhance uptake. They may interact to enhance EBP uptake and patient outcomes. This R01 application proposes a randomized, hybrid type 3 effectiveness-implementation trial to: 1) test the main and interactive effects of TEAM and LEAD facilitation augmentation on provider implementation and clinical outcomes, 2) test for target engagement and mediation at the team and leadership levels, and 3) examine selected practice, provider, and family moderators of implementation. The state-wide sample includes 24 primary care practices from the medical home program of the American Academy of Pediatrics-Pennsylvania Chapter. After standard training in the DOCC EBP, all practices will be randomized to one of four conditions: 1) No TEAM or LEAD; 2) TEAM only; 3) LEAD only, and 4) TEAM+LEAD. TEAM and LEAD facilitation will be delivered via videoconference on a graded schedule over 18 months. Care teams will deliver DOCC to 25 children who meet the clinical cutoff (75th percentile) on the Pediatric Symptom Checklist-17 Externalizing scale and their caregivers. We will collect practice/provider measures from 175 practice staff (0, 6, 12, 18, 24 months) and 600 caregivers (i.e., 0, 3, 6, 12 months) to support all analyses. Collection of generalizable data to routine pediatric practice will yield new knowledge about the impact, mediators, and moderators of CCM implementation. In one of the first large-scale pediatric trials of a service system intervention to address these aims and respond to RFA-MH-18-701 and the NIMH’s Strategic Plan (4.2), this trial will advance the implementation science knowledge needed to refine promising strategies for accelerating the delivery and scale-up of DOCC in a pediatric medical home.