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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT04946253
Status
Recruiting
Apply to this trial

Conditions

  • Attention Deficit and Disruptive Behavior Disorders
  • Child Behavior Problem

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DOCC: Evidence-based treatment for disruptive behavior and ADHD — BEHAVIORAL
    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).
  • TEAM: Implementation support strategies at the care team level following standard implementation of DOCC — BEHAVIORAL
    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.
  • Implementation support strategies at the leadership level following standard implementation of DOCC — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 28, 2021
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DOCC with standard implementation (No TEAM or LEAD)
    Practices in this arm will receive DOCC materials/training and technical support, but will not receive care team coaching/consultation (TEAM) or practice leadership facilitation (LEAD) after the training phase.
  • Experimental: DOCC with TEAM implementation
    Practices in this arm will receive DOCC training and materials and one type of implementation support after the training: coaching/consultation for the provider care team (TEAM).
  • Experimental: DOCC with LEAD implementation
    Practices in this arm will receive DOCC training and materials and only one type of implementation support after the training: facilitation for practice leadership (LEAD).
  • Experimental: DOCC with TEAM + LEAD implementation
    Practices in this arm will receive DOCC training and materials and both types of implementation support after the training: coaching/consultation for the provider care team (TEAM) and facilitation for practice leadership (LEAD).

Primary Outcome Measure

Total number of DOCC encounters [ Time Frame: Throughout services after each contact, up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Drexel UniversityPhiladelphiaPennsylvania19104
Renee M Turchi, MD, MPH
[email protected]
267-359-6051
Renee M Turchi, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260
David J Kolko, PhD
[email protected]
4122465888
David J Kolko, PhD (PRINCIPAL_INVESTIGATOR)
Satish Iyengar, PhD (SUB_INVESTIGATOR)

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Drexel University· Philadelphia, PAUniversity of Pittsburgh· Pittsburgh, PA

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