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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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).
• Поведенческое 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 DO
• Поведенческое 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, p

Первичные конечные точки

• Total number of DOCC encounters [Срок оценки: Throughout services after each contact, up to 12 months]
• Care management competencies and functions [Срок оценки: At provider baseline]
• Change from baseline in care management competencies and functions at 6 months [Срок оценки: 6 months after provider baseline]
• Change from baseline in care management competencies and functions at 12 months [Срок оценки: 12 months after provider baseline]
• Change from baseline in care management competencies and functions at 18 months [Срок оценки: 18 months after provider baseline]
• Change from baseline in care management competencies and functions at 24 months [Срок оценки: 24 months after provider baseline]
• Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community [Срок оценки: At caregiver baseline]
• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 3 months [Срок оценки: 3 months after caregiver baseline]
• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 6 months [Срок оценки: 6 months after caregiver baseline]
• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 12 months [Срок оценки: 12 months after caregiver baseline]

Критерии участия

The investigators propose to recruit 4 types of practice provider participants (PCP = primary care provider, CM = care manager, SL = Senior Leader, PM = practice manager) as well as caregiver participants.

Критерии включения

• PCP 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 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)

Критерии исключения

• Caregivers

• Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Drexel University — Philadelphia
• University of Pittsburgh — Pittsburgh

Публикации

• Kolko DJ, Campo JV, Kelleher K, Cheng Y. Improving access to care and clinical outcome for pediatric behavioral problems: a randomized trial of a nurse-administered intervention in primary care. J Dev Behav Pediatr. 2010 Jun;31(5):393-404. doi: 10.1097/DBP.0b013e3181dff307. PMID 20495474
• 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. PMID 22064876
• Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D, Wisniewski S. Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Pediatrics. 2014 Apr;133(4):e981-92. doi: 10.1542/peds.2013-2516. Epub 2014 Mar 24. PMID 24664093
• Kolko DJ, Hart JA, Campo J, Sakolsky D, Rounds J, Wolraich ML, Wisniewski SR. Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care. Clin Pediatr (Phila). 2020 Jul;59(8):787-800. doi: 10.1177/0009922820920013. PMID 32503395
• 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. PMID 31760174
• Yu H, Kolko DJ, Torres E. Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs? Fam Syst Health. 2017 Mar;35(1):46-57. doi: 10.1037/fsh0000251. PMID 28333516
• McGuier EA, Kolko DJ, Klem ML, Feldman J, Kinkler G, Diabes MA, Weingart LR, Wolk CB. Team functioning and implementation of innovations in healthcare and human service settings: a systematic review protocol. Syst Rev. 2021 Jun 26;10(1):189. doi: 10.1186/s13643-021-01747-w. PMID 34174962
• 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. PMID 35193619

Идентификаторы

NCT: NCT04946253 · STUDY20080207 · R01MH124914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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