Impact of 4PCP on Practitioner and Patient Outcomes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Virginia Commonwealth University
Study ID
NCT05580419
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 17, 2023
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
1,188 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Jeff Janata, M.D.
[email protected]
Virginia Commonwealth UniversityRichmondVirginia23298-
SSM HealthMadisonWisconsin53716
Al Musa, M.D.
[email protected]
Wisconsin Research and Education Network (WREN)MadisonWisconsin53715
Mary Henningfield, PhD
[email protected]

Find similar trials in Cleveland, OH

By research site
Case Western Reserve University· Cleveland, OHVirginia Commonwealth University· Richmond, VASSM Health· Madison, WIWisconsin Research and Education Network (WREN)· Madison, WI

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