Recruiting

4PCP

Sponsor:

Virginia Commonwealth University

Code:

NCT05580419

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

4PCP Course

Study Details

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

Study ID

NCT05580419

Start date

Mar 17, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Practitioner Inclusion:

  • 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

Patient inclusion:

  • 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

Practitioner exclusion:

  • Pain specialists
  • Unable to fully answer questionnaires
  • Unable to attend the 4PCP course
  • Non-English speaking

Patient exclusion:

  • 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

Study Design

Enrollment

1188 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 4PCP Course (for practitioners only)

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.

Interventions

4PCP Course

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.

Primary outcome measure

  • Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3) [ Time Frame: 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) [ Time Frame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation ]
  • Number of Patient Participants whose opioid dose tapered [ Time Frame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation ]

Central Contacts and Locations

Central contacts

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Wisconsin Research and Education Network (WREN)

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Mary Henningfield, PhD

Mary.Henningfield@fammed.wisc.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-11-25.