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

  • STATUS
    Recruiting
  • End date
    Nov 13, 2025
  • participants needed
    850
  • sponsor
    University of Pittsburgh
Updated on 13 December 2021

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 teamand practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.

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 statewide sample includes 24 primary care practices from the Medical Home Program of the Pennsylvania Chapter of the American Academy of Pediatrics. 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 (or possibly in person) on a graded schedule. Care teams will deliver DOCC to 25 children 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.

Details
Condition Child Behavior Problem, Attention Deficit and Disruptive Behavior Disorders
Treatment DOCC: Evidence-based treatment for disruptive behavior and ADHD, TEAM: Implementation support strategies at the care team level following standard implementation of DOCC, Implementation support strategies at the leadership level following standard implementation of DOCC
Clinical Study IdentifierNCT04946253
SponsorUniversity of Pittsburgh
Last Modified on13 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Practice Staff
Employed at one of the twenty-four (24) pediatric primary care practices identified by the PA Chapter of the American Academy of Pediatrics. The investigators propose to recruit 4 types of participants (PCP = primary care provider, CM = care manager, MD = Medical Director, PM = practice manager)
Identified by the practice as a Primary Care Provider (PCP Participants)
Identified by the practice as the Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager. (CM Participants)
Identified by the practice as the Lead Physician/Medical Director. (MD Participants)
Identified by the practice as the Practice Manager (or equivalent position). (PM Participants)
Caregivers
Have a child age 5-12 years old who exhibits at least a modest level of behavior problems (Caregiver Participants)
Are at least 18 years of age (Caregiver participants)
Have parental rights for this child (Caregiver participants)

Exclusion Criteria

Caregivers
Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)
Child's primary care provider is not enrolled in the study (Caregiver participants)
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