Impact of 4PCP on Practitioner and Patient Outcomes

NCT05580419 | Recruiting DMC

• 2 other identifiers: HM20025110R01HS028630
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 4

Brief Summary

Reducing opioid prescribing and improving outcomes in patients with chronic pain would benefit our nation. Neither addiction nor chronic pain spares any race, gender, or particular socio-economic status. This study is investigating a potentially inexpensive way of providing a previously costly service (the intensive chronic pain rehabilitation program), which is why insurers stopped covering it. Although it is unusual for an application from an academic institution to include a startup company (PainSTakers, LLC) as the curriculum provider, this is actually a long-term strength of this program, and the reason NIH recommended this route. It ensures that 4PCP will ultimately sustain itself rather than require government support for its continuation. Support for this application is not to provide the curriculum, but to determine if it is effective in the outcomes expected to be found. The curriculum is being provided freely only as an incentive for practitioners to participate in the research portion of the study. If the study is able to demonstrate its clinical effectiveness, the next step will be to show a positive economic impact for health care institutions and for health insurers who may then wish to support the program for their practitioners and their patients.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)

  Pain, Enjoyment of Life and General Activity will be assessed using the PEG-3 which is a self-report, 3 item survey which asks patient participants to rate their experiences on a 10 point Likert scale.

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)

  Practitioner chronic pain perspectives will be assessed using the CPPP, which is a self-report 26 item survey that asks practitioners to rate feelings related chronic pain on a 6 point Likert scale.

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Number of Patient Participants whose opioid dose tapered

  Opioid Morphine milligram equivalents (MME) MME will be calculated from medical record/state prescription monitoring data to determine changes in patient opioid use. Based on MME changes, number of patients whose dose is tapered by at least 5% over 6 months will be counted.

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

Secondary Outcomes (9)

• Change in Patient Participant Pain Catastrophizing Scale (PCS)

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Change in Patient Participant Pain Interference (PI)

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Change in Patient Participant Quality of Life (QoL)

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Change in Patient Participant Generalized Anxiety Disorder (GAD-7)

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

• Change in Patient Participant Patient Health Questionnaire (PHQ-9)

  Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

Study Arms (1)

4PCP Course (for practitioners only)

EXPERIMENTAL

All enrolled practitioners will be assigned to take the 4PCP course as the intervention. Patients will not be assigned to the course and will only be completing surveys before and after their practitioner completes 4PCP.

Behavioral: 4PCP Course

Interventions

4PCP Course BEHAVIORAL

4PCP is a training framework for the management of chronic pain and gives practitioners lasting knowledge on how to better care for chronic pain patients.

4PCP Course (for practitioners only)

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General practitioners
• Part of a practice that has their own identifiable patient population including patients with chronic pain
• Able to fully answer questionnaires
• Able to attend 4PCP course
• English speaking
• Age 14-80
• Self-report of chronic non-malignant pain \> 3 months
• No foreseeable or planned surgeries for chronic pain
• Has attended at least 2 established visits in the enrolled practitioner's practice
• English speaking

You may not qualify if:

• Pain specialists
• Unable to fully answer questionnaires
• Unable to attend the 4PCP course
• Non-English speaking
• Unable to answer questionnaires (e.g. stroke, dementia, developmental delay, etc.)
• Followed in a specialty pain clinic (PCP not managing pain care)
• Sickle cell disease
• Prisoners
• Non-English speaking

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Medical College of Wisconsin: collaborator
• Case Western Reserve University: collaborator
• SSM Health: collaborator
• Wisconsin Research and Education Network: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (4)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Wisconsin Research and Education Network (WREN)

Madison, Wisconsin, 53715, United States

RECRUITING

SSM Health

Madison, Wisconsin, 53716, United States

NOT YET RECRUITING

Related Publications (4)

• Chelimsky TC, Fischer RL, Levin JB, Cheren MI, Marsh SK, Janata JW. The primary practice physician program for chronic pain ((c) 4PCP): outcomes of a primary physician-pain specialist collaboration for community-based training and support. Clin J Pain. 2013 Dec;29(12):1036-43. doi: 10.1097/AJP.0b013e3182851584.

  PMID: 23459398 BACKGROUND

• Why the US Should Develop a Primary Medical Specialty in Pain Medicine. American Board of Pain Medicine [Web]; Available from: http://abpm.org/uploads/files/talking%20points%20-%20federal%20approach%20needed%20final.pdf

  BACKGROUND

• Okumura MJ, Heisler M, Davis MM, Cabana MD, Demonner S, Kerr EA. Comfort of general internists and general pediatricians in providing care for young adults with chronic illnesses of childhood. J Gen Intern Med. 2008 Oct;23(10):1621-7. doi: 10.1007/s11606-008-0716-8. Epub 2008 Jul 26.

  PMID: 18661191 BACKGROUND

• Aydede M, Shriver A. Recently introduced definition of "nociplastic pain" by the International Association for the Study of Pain needs better formulation. Pain. 2018 Jun;159(6):1176-1177. doi: 10.1097/j.pain.0000000000001184. No abstract available.

  PMID: 29768305 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Chelimsky, M.D.

  VCU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Chelimsky, M.D.

CONTACT

(804)-628-0145; thomas.chelimsky@vcuhealth.org

Madison Maxwell, B.S.

CONTACT

madison.maxwell@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded, stepped cluster design trial

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: March 17, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)