NCT05580419 Impact of 4PCP on Practitioner and Patient Outcomes
| NCT ID | NCT05580419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,188 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,188 participants in total. It began in 2023-03-17 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Thomas Chelimsky, M.D.
PRINCIPAL INVESTIGATOR
VCU
Frequently Asked Questions
Who can join the NCT05580419 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05580419 currently recruiting?
Yes, NCT05580419 is actively recruiting participants. Contact the research team at thomas.chelimsky@vcuhealth.org for enrollment information.
Where is the NCT05580419 trial being conducted?
This trial is being conducted at Cleveland, United States, Richmond, United States, Madison, United States, Madison, United States.
Who is sponsoring the NCT05580419 clinical trial?
NCT05580419 is sponsored by Virginia Commonwealth University. The principal investigator is Thomas Chelimsky, M.D. at VCU. The trial plans to enroll 1,188 participants.
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