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Impact of 4PCP on Practitioner and Patient Outcomes

Study acronym: 4PCP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study description expanded, about 18 words
    • Site details revised at 4 of 4 sites
    • Publications: details revised at 4 of 4 entries
  2. Primary completion date: Oct 2025 to Sep 2027
    • Study completion date: Oct 2027 to Sep 2027
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Eligibility criteria shortened, about 60 words
    • Study description shortened, about 545 words
    v9
  5. Primary endpoints revised (3)v8 Show 5 more changesShow less
    • Interventions: 4PCP Training (Behavioral) to 4PCP Course (Behavioral)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 64 words
    • Site details revised at 1 of 4 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 4v7
  2. Trial status: Suspended to Recruiting
    • Start date: Nov 9, 2022 to Mar 17, 2023
    • Site details revised at 5 of 5 sites
    v6
  3. Trial status: Recruiting to Suspended Sponsor's reason: Transitioning study to a central IRB, study suspended until that process is completed
    • Site details revised at 5 of 5 sites
    v5
  4. Start date changed from estimate of Nov 2022 to Nov 9, 2022
    • Site contacts updated at 1 of 5 sites
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 5
    • Start date: Oct 2022 to Nov 2022
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05580419
Lead Sponsor Virginia Commonwealth University
Collaborators: Medical College of Wisconsin, Case Western Reserve University, SSM Health, Wisconsin Research and Education Network, Agency for Healthcare Research and Quality (AHRQ)
Conditions
(from sponsor)		 Chronic Pain
Related terms Chronic Pain
Enrollment 1,188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov