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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Intervention Staffing and Training Flexibility- ARCHIVED

CHAPTER SECTIONS

ARCHIVED PAGE

Archived on August 7, 2025. Go to the latest version.

Dissemination and Implementation


Section 8


Intervention Staffing and Training Flexibility- ARCHIVED

Expand Contributors
Douglas Zatzick, MD

Leah Tuzzio, MPH

David Chambers, DPhil

Jerry Suls, PhD

Doyanne Darnell, PhD

Gloria Coronado, PhD

Lynn DeBar, PhD, MPH

 

Beverly Green, MD, MPH

Susan S. Huang, MD, MPH

Jeffrey G. Jarvik, MD, MPH

Edward Septimus, MD, FACP

Gregory Simon, MD, MPH

Miguel Vazquez, MD

Contributing Editor
Karen Staman, MS

Case Example: Collaborative Care for Chronic Pain in Primary Care (PPACT)

Collaborative Care for Chronic Pain in Primary Care (PPACT) is a trial targeting patients with chronic pain receiving long term opioid treatment and is designed to help patients adopt self-management skills for chronic pain, limit use of opioid medications, and identify factors amenable to treatment in the primary care setting (Debar et al. 2012, Debar et al. 2018). The trial is being carried out in the regions of Kaiser Permanente (KP) Georgia, Hawaii, and the Northwest (Oregon/Southwest Washington) and relies on an interdisciplinary team (nurse case managers, behavioral specialists, physical therapists, and pharmacists) to carry out the intervention and support the primary care providers in working with their patients enrolled in the intervention. By design, PPACT interventionists continue ongoing frontline clinical work in participating healthcare systems in addition to their work implementing PPACT. While this helps to ensure that the intervention is as closely integrated into the health care delivery system as possible, it has also meant that the study is vulnerable to many forces within the health care systems that affect staffing in the requisite areas. This has influenced availability of clinicians for the study and staff turn-over across the studies. For example, the simultaneous integration of behavioral health specialists into primary care in the KP Hawaii and Northwest regions has led to a dearth of adequately trained clinicians and led to the use of health coaches at KP Hawaii rather than behavioral health specialists, as well as the need to rehire and train for the behavioral health role multiple times at KP Northwest. At KP Georgia the consolidation of nurses in primary care clinics has led to many cohorts of the intervention being conducted without the involvement of a nurse case manager. Further, physical therapy is carved out of the integrated health plan at KP Georgia leading to the need to organize communications and hand offs between interdisciplinary team members differently in that region. Across all performance sites we have streamlined intervention training and customized it depending on the experience and professional scope of work of those from different disciplines.

Strategy Details
Diffusion By design, PPACT interventionists were dually employed by the health plan and had other professional responsibilities in addition to delivering the intervention. These interventionists (nurses, behavioral specialists, physical therapists) often reported modifying their practice approaches more broadly based on what they’d learned through the PPACT training and involvement in the study.
Dissemination At times these same interventionists were also asked by KP clinical leaders and administrators to describe the PPACT intervention approach to other clinicians in the health care systems and to work with the leaders/administrators to adapt feasible components for use more broadly in the health care systems.
Implementation By design, a larger group of KP clinicians were allowed and encouraged to participate in the PPACT intervention trainings to promote familiarity with the program and aid clinical communication between the PPACT intervention team and other clinicians within participating health care systems.
Sustainability Because of the variable nature of the clinical collection of pain-related patient reported outcomes at the beginning of the study, investigators identified a psychometrically validated but abbreviated version of the standard brief pain inventory scale (the PEGS – Krebs et al, 2009) and worked with KP nationally to adopt and build within the questionnaire section of the electronic health record. This is now the standard pain measure used in the three health care systems participating in the PPACT trial.

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction – ARCHIVED
  2. Dissemination and Implementation Frameworks – ARCHIVED
  3. Let It, Help It, Make It Happen – ARCHIVED
  4. Changes to Policy and Guidelines – ARCHIVED
  5. Legislative Changes- ARCHIVED
  6. Creation of Targeted Tools- ARCHIVED
  7. Stepped Wedge Designs- ARCHIVED
  8. Intervention Staffing and Training Flexibility- ARCHIVED
  9. Pragmatic Implementation Process Assessments- ARCHIVED
  10. Partnering With Quality Improvement and Population Health Initiatives- ARCHIVED
  11. Implementation in the Trial Versus in the Real World- ARCHIVED
  12. Additional Resources- ARCHIVED
  13. FAQ- ARCHIVED

REFERENCES

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Debar LL, Kindler L, Keefe FJ, et al. 2012. A primary care-based interdisciplinary team approach to the treatment of chronic pain utilizing a pragmatic clinical trials framework. Transl Behav Med. 2:523–530. doi:10.1007/s13142-012-0163-2. PMID:23440672

DeBar L, Benes L, Bonifay A, et al. 2018. Interdisciplinary Team-Based Care for Patients with Chronic Pain on Long-Term Opioid Treatment in Primary Care (PPACT) – Protocol for a Pragmatic Cluster Randomized Trial. Contemp Clin Trials. 6;67:91-99. doi: 10.1016/j.cct.2018.02.015. PMID: 29522897

Krebs EE, Lorenz KA, Bair MJ, et al. 2009. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 24:733–738. doi:10.1007/s11606-009-0981-1. PMID:19418100.

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Version History

December 5, 2018: Added reference (change made by K. Staman).

Published August 25, 2017

current section :

Intervention Staffing and Training Flexibility- ARCHIVED

  1. Introduction – ARCHIVED
  2. Dissemination and Implementation Frameworks – ARCHIVED
  3. Let It, Help It, Make It Happen – ARCHIVED
  4. Changes to Policy and Guidelines – ARCHIVED
  5. Legislative Changes- ARCHIVED
  6. Creation of Targeted Tools- ARCHIVED
  7. Stepped Wedge Designs- ARCHIVED
  8. Intervention Staffing and Training Flexibility- ARCHIVED
  9. Pragmatic Implementation Process Assessments- ARCHIVED
  10. Partnering With Quality Improvement and Population Health Initiatives- ARCHIVED
  11. Implementation in the Trial Versus in the Real World- ARCHIVED
  12. Additional Resources- ARCHIVED
  13. FAQ- ARCHIVED

Citation:

Zatzick D, Tuzzio L, Chambers D, et al. Dissemination and Implementation: Intervention Staffing and Training Flexibility- ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/dissemination-implementation-top/intervention-staffing-and-training-flexibility/. Updated December 3, 2025. DOI: 10.28929/079.

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