Clinical trial NCT04946253: SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
Official title: Care Team and Practice Level Implementation Strategies to Optimize Pediatric Collaborative Care: A Cluster-Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior Problem
Attention Deficit and Disruptive Behavior Disorders
Keywords: Oppositional Defiant Disorder
Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Drexel University
name: NYU Langone Health
name: University of Michigan
name: National Institute of Mental Health (NIMH)
name: Pennsylvania American Academy of Pediatrics
First posted: 2021-06-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators propose a randomized trial using a factorial design to test effects of implementation support strategies on uptake of an evidence-based intervention (DOCC) in up to 24 primary care practices. Practices will receive DOCC training in accord with the Replicating Effective Programs model. Practices will be randomized to 1 of 4 implementation support conditions: 1) No TEAM/LEAD (training and technical support only); 2) provider care team consultation (TEAM); 3) practice leadership facilitation (LEAD); and 4) combination of provider care team and leadership implementation (TEAM+LEAD). Care teams in each practice will identify families and deliver DOCC to 20 caregivers and their children with externalizing behavior. Investigators will collect measures from 90 practice staff over 5 assessments (24 months) and 360 caregivers over 4 assessments (12 months) to support analyses.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Caregivers

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

Primary outcomes:
measure: Total number of DOCC encounters
timeFrame: Throughout services after each contact, up to 12 months
measure: Care management competencies and functions
timeFrame: At provider baseline
measure: Change from baseline in care management competencies and functions at 6 months
timeFrame: 6 months after provider baseline
measure: Change from baseline in care management competencies and functions at 12 months
timeFrame: 12 months after provider baseline
measure: Change from baseline in care management competencies and functions at 18 months
timeFrame: 18 months after provider baseline
measure: Change from baseline in care management competencies and functions at 24 months
timeFrame: 24 months after provider baseline
measure: Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community
timeFrame: At caregiver baseline
measure: Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 3 months
timeFrame: 3 months after caregiver baseline
measure: Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 6 months
timeFrame: 6 months after caregiver baseline
measure: Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 12 months
timeFrame: 12 months after caregiver baseline
measure: Severity of ADHD, ODD/CD, and ANX/DEP symptoms at school
timeFrame: At teacher baseline
measure: Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 3 months
timeFrame: 3 months after teacher baseline
measure: Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 6 months
timeFrame: 6 months after teacher baseline
measure: Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 12 months
timeFrame: 12 months after teacher baseline
measure: Pediatric Health Quality
timeFrame: At caregiver baseline
measure: Change from baseline in Pediatric Health Quality at 3 months
timeFrame: 3 months after caregiver baseline
measure: Change from baseline in Pediatric Health Quality at 3 months
timeFrame: 6 months after caregiver baseline
measure: Change from baseline in Pediatric Health Quality at 12 months
timeFrame: 12 months after caregiver baseline
measure: Professional perceptions of study experiences at 18 months
timeFrame: 18 months after professional baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David J Kolko, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.