Implementation support for collaborative care in pediatric practices

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

This study is testing new ways to help pediatric practices use a program called Doctor Office Collaborative Care to better manage behavior problems and ADHD in children.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 2 sites (Philadelphia, Pennsylvania and 1 other locations)
• Trial ID: NCT04946253 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of implementation strategies aimed at enhancing the uptake of an evidence-based intervention called Doctor Office Collaborative Care (DOCC) for managing child behavior problems and ADHD in pediatric primary care settings. It employs a randomized, hybrid effectiveness-implementation design involving up to 24 primary care practices. The study tests two levels of implementation support: strategies directed at the care team and those aimed at practice leadership. By assessing the separate and combined effects of these strategies, the research aims to optimize the delivery of DOCC in diverse pediatric practices.

Who should consider this trial

Good fit: Ideal candidates for this study include pediatric primary care practices and their providers involved in the management of child behavior issues and ADHD.

Not a fit: Patients who are not part of the participating primary care practices or those with severe behavioral issues requiring specialized care may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management of childhood behavior problems and ADHD in primary care settings, leading to better outcomes for affected children.

How similar studies have performed: While the specific implementation strategies being tested have not been formally evaluated in pediatric primary care, the general approach of enhancing care delivery through structured support has shown promise in other settings.

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)

Where this trial is running

Philadelphia, Pennsylvania and 1 other locations

• Drexel University — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: David J Kolko, PhD — University of Pittsburgh
• Study coordinator: Kevin M Rumbarger, BA

Conditions Child Behavior Problem; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Attention Deficit Hyperactivity Disorder