SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
NCT ID: NCT04946253
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2021-11-28
2026-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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.
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).
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).
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).
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.
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).
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).
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.
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).
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).
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.
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.
Interventions
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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).
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as a Primary Care Provider
* CM Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager.
* SL Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as the Senior Leader.
* Have a practice-level leadership role such as Medical Director or a clinical/practice leader
* Have administrative responsibilities related to patient care and/or the operations/management of the practice
* PM Participants:
* Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
* Identified by the practice as the Practice Manager or equivalent position
* Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice.
* Caregiver Participants:
* 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
* Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)
18 Years
ALL
No
Sponsors
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American Academy of Pediatrics
OTHER
Drexel University
OTHER
NYU Langone Health
OTHER
University of Michigan
OTHER
National Institute of Mental Health (NIMH)
NIH
Pennsylvania American Academy of Pediatrics
UNKNOWN
University of Pittsburgh
OTHER
Responsible Party
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David Kolko
Professor of Psychiatry, Psychology, Pediatrics, and Clinical and Translational Science
Principal Investigators
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David J Kolko, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Drexel University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Dikhanov GG, Mishan'kin BN. [Comparative study of ribosomal proteins from Yersinia pestis and Escherichia coli: amino acid composition and electrophoretic mobility]. Mol Gen Mikrobiol Virusol. 1988 Aug;(8):32-5. Russian.
Kolko DJ, Campo JV, Kilbourne AM, Kelleher K. Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial. Arch Pediatr Adolesc Med. 2012 Mar;166(3):224-31. doi: 10.1001/archpediatrics.2011.201. Epub 2011 Nov 7.
Tsai CC, Williamson HO, Kirkland BH, Braun JO, Lam CF. Low-dose oral contraception and blood pressure in women with a past history of elevated blood pressure. Am J Obstet Gynecol. 1985 Jan 1;151(1):28-32. doi: 10.1016/0002-9378(85)90418-1.
Ballogh Z, Whaley K. Hereditary angio-oedema: its pathogenesis and management. Scott Med J. 1980 Jul;25(3):187-95. doi: 10.1177/003693308002500303.
McGuier EA, Kolko DJ, Ramsook KA, Huh AS, Berkout OV, Campo JV. Effects of Primary Care Provider Characteristics on Changes in Behavioral Health Delivery During a Collaborative Care Trial. Acad Pediatr. 2020 Apr;20(3):399-404. doi: 10.1016/j.acap.2019.11.008. Epub 2019 Nov 21.
Glukhen'kii TT, Gude ZZh. [The blood level of certain monosaccharides in patients with eczema]. Vestn Dermatol Venerol. 1969 Apr;43(4):33-5. No abstract available. Russian.
Paoni NF, Keyt BA, Refino CJ, Chow AM, Nguyen HV, Berleau LT, Badillo J, Pena LC, Brady K, Wurm FM, et al. A slow clearing, fibrin-specific, PAI-1 resistant variant of t-PA (T103N, KHRR 296-299 AAAA). Thromb Haemost. 1993 Aug 2;70(2):307-12.
Meier DA, Nagle CE. Differential diagnosis of a tender goiter. J Nucl Med. 1996 Oct;37(10):1745-7.
Kolko DJ, McGuier EA, Turchi R, Thompson E, Iyengar S, Smith SN, Hoagwood K, Liebrecht C, Bennett IM, Powell BJ, Kelleher K, Silva M, Kilbourne AM. Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial. Implement Sci. 2022 Feb 22;17(1):20. doi: 10.1186/s13012-022-01195-7.
Other Identifiers
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STUDY20080207
Identifier Type: -
Identifier Source: org_study_id
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