Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial

David J Kolko,Satish Iyengar,Kimberly Hoagwood,Maria Silva,Ian M Bennett,Celeste Liebrecht,Kelly Kelleher,Shawna N Smith,Elizabeth A Mcguier,Renee Turchi,Eileen Thompson,Byron J Powell,Amy M Kilbourne

doi:10.1186/s13012-022-01195-7

Abstract

BackgroundImplementation facilitation is an effective strategy to support the implementation of evidence-based practices (EBPs), but our understanding of multilevel strategies and the mechanisms of change within the “black box” of implementation facilitation is limited. This implementation trial seeks to disentangle and evaluate the effects of facilitation strategies that separately target the care team and leadership levels on implementation of a collaborative care model in pediatric primary care. Strategies targeting the provider care team (TEAM) should engage team-level mechanisms, and strategies targeting leaders (LEAD) should engage organizational mechanisms.MethodsWe will conduct a hybrid type 3 effectiveness–implementation trial in a 2 × 2 factorial design to evaluate the main and interactive effects of TEAM and LEAD and test for mediation and moderation of effects. Twenty-four pediatric primary care practices will receive standard REP training to implement Doctor–Office Collaborative Care (DOCC) and then be randomized to (1) Standard REP only, (2) TEAM, (3) LEAD, or (4) TEAM + LEAD. Implementation outcomes are DOCC service delivery and change in practice-level care management competencies. Clinical outcomes are child symptom severity and quality of life.DiscussionThis statewide trial is one of the first to test the unique and synergistic effects of implementation strategies targeting care teams and practice leadership. It will advance our knowledge of effective care team and practice-level implementation strategies and mechanisms of change. Findings will support efforts to improve common child behavioral health conditions by optimizing scale-up and sustainment of CCMs in a pediatric patient-centered medical home.Trial registrationClinicalTrials.gov, NCT04946253. Registered June 30, 2021.

Highlights

Implementation facilitation is an effective strategy to support the implementation of evidence-based practices (EBPs), but our understanding of multilevel strategies and the mechanisms of change within the “black box” of implementation facilitation is limited
Current study We propose to disentangle and further refine facilitation strategies targeting the care team and leadership levels to support implementation of a collaborative care models (CCM) in pediatric primary care
Effective behavioral health interventions based on the CCM are among the most complex healthcare services provided in primary care

Summary

Methods

Study design We propose a hybrid type 3, cluster-randomized effectiveness–implementation trial in a 2 × 2 factorial design in 24 pediatric primary care practices across Pennsylvania. TEAM and LEAD targets and mediators of implementation outcomes Primary Care Team Dynamics Survey (PCTDS) Staff will complete the 29-item PCTDS to assess affective, behavioral, and cognitive dimensions of team functioning and overall team effectiveness [127]. It has high reliability and discriminant validity [127]. We hypothesize that relative to REP only, TEAM, LEAD, and their interaction will significantly improve (1) the number of DOCC service encounters per case and (2) collaborative care competencies within the practice. Authorship decisions will be based on the International Committee of Medical Journal Editors criteria [144]

Discussion

Background

Findings