SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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.
Disqualifiers
Caregivers
Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)
Trial design
Design model
Factorial
Treatments tested in this trial
DOCC: Evidence-based treatment for disruptive behavior and ADHD
BehavioralPractices 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
BehavioralPractices 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
BehavioralPractices 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.
Treatment groups
450 Participants
are divided into 4 treatment groupsGroup A: DOCC with standard implementation (No TEAM or LEAD)Active comparator 1 intervention
Group B: DOCC with TEAM implementationExperimental treatment 2 interventions
Group C: DOCC with LEAD implementationExperimental treatment 2 interventions
Group D: DOCC with TEAM + LEAD implementationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Total number of DOCC encounters
As part of a short checklist-style progress note completed after each service contact and housed in the study's web-based patient registry dashboard, providers will document each DOCC encounter delivered to each family. These encounters include referral, assessment, treatment or medication delivery, medication or treatment review/monitoring, case management, review of emergent symptoms, and care management and consultation meetings involving a family member. Investigators will report the total number of DOCC encounters delivered to each family during the intervention phase.
Time frame
Throughout services after each contact, up to 12 months2
Care management competencies and functions
The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.
Time frame
At provider baseline3
Change from baseline in care management competencies and functions at 6 months
The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.
Time frame
6 months after provider baseline4
Change from baseline in care management competencies and functions at 12 months
The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.
Time frame
12 months after provider baselineSponsors and contacts
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University of Pittsburgh
Lead sponsor
American Academy of Pediatrics
Collaborator
Drexel University
Collaborator
NYU Langone Health
Collaborator
University of Michigan
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Pennsylvania American Academy of Pediatrics
Collaborator
Source ClinicalTrials.gov