NCT04946253

SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.

Detailed description

This study is a randomized, hybrid type 3 effectiveness-implementation trial to support the adoption of a chronic care model (CCM)-based intervention in pediatric primary care settings by testing the impact of implementation strategies directed towards the provider care team (TEAM) or practice leadership (LEAD) level. The treatment investigators seek to deliver here is called Doctor Office Collaborative Care (DOCC), an evidence-based intervention for the management of child behavior problems and comorbid ADHD. The implementation strategies being tested to enhance DOCC uptake include TEAM coaching/consultation strategies, which will be delivered to care team providers and target provider competency to deliver DOCC, and LEAD facilitation strategies, which will be delivered to practice leaders and target organizational support of DOCC delivery. These multi-level implementation strategies have not been formally evaluated to learn about their separate and combined effects in any randomized clinical trial conducted in pediatric primary care. Such information is needed to optimize our approaches to promoting the implementation of a CCM-based intervention in pediatric practice. The sample includes up to 24 primary care practices from a statewide network and other networks or states. After standard training in the DOCC EBP, all practices will be randomized to one of four implementation conditions: 1) No TEAM or LEAD (ongoing technical support only); 2) TEAM implementation; 3) LEAD implementation, or 4) TEAM+LEAD implementation. TEAM and LEAD implementation will be delivered via videoconference on a graded schedule. Care teams will deliver DOCC to up to 25 children (or more if requested by the practice) who meet a clinical cutoff for modest behavior problems and their caregivers. Investigators will collect practice/provider measures from enrolled practice staff (0, 6, 12, 18, 24 months) and caregivers over several timepoints (0, 3, 6, 12 months) to support all analyses evaluating implementation and treatment outcomes, mediation, and moderation. By proposing one of the first large pragmatic pediatric trials of a CCM-based evidence-based intervention to address these aims in response to RFA-MH-18-701 and the NIMH's Strategic Plan (4.2), this research will advance the implementation science knowledge needed to optimize promising strategies for promoting the delivery and scale-up of DOCC in a pediatric medical home.

Conditions

• Child Behavior Problem
• Attention Deficit and Disruptive Behavior Disorders

Interventions

Type	Name	Description
BEHAVIORAL	DOCC: Evidence-based treatment for disruptive behavior and ADHD	Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. The content covers key topics related to the treatment of behavior problems (e.g., self-management, positive parenting) and ADHD (e.g., psychoeducation, medication).
BEHAVIORAL	TEAM: Implementation support strategies at the care team level following standard implementation of DOCC	Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Coaching and consultation will be provided to the provider care team to support the use of collaborative care for behavior problems and ADHD. The TEAM intervention includes regular virtual meetings or calls with the providers (about once/month, on average) that cover core chronic care model functions, including registry use, case-finding, collaborative care team roles, and workflows outlining how DOCC is delivered in the practice.
BEHAVIORAL	Implementation support strategies at the leadership level following standard implementation of DOCC	Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Practice facilitation will be provided to practice leaders to help them support the care team's use of collaborative care for behavior problems and ADHD. The LEAD intervention includes regular virtual meetings or calls with practice leaders (about once/month, on average) that cover the assessment of practice capacity/barriers, ways to overcome organizational barriers and support staff use of DOCC, promoting innovation, and leveraging practice resources to support DOCC delivery and maintenance in the practice.

Timeline

• Start date: 2021-11-28
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2021-06-30
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States