Impact of 4PCP on Practitioner and Patient Outcomes

NCT ID: NCT05580419

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-17

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Practitioner procedures:

After the completion of informed consent, practitioners will be sent their first set of surveys (Baseline).

1 week before the first day of the practitioner's course, they will be sent a second set of surveys (Time 0).

6 months after course completion, practitioners will be sent their next set of surveys (Follow Up 1).

6 months after the distribution of Follow Up Survey 1, practitioners will be sent their next set of surveys (Follow Up 2).

6 months after the distribution of Follow Up Survey 2, practitioners will be sent their next set of surveys (Follow Up 3).

6 months after the distribution of Follow Up Survey 3, practitioners will be sent their final set of surveys (Follow Up 4).

Patient procedures:

After the completion of informed consent, patients will be sent their first set of surveys (Baseline).

1 week before the first day of the patient's practitioner's course, they will be sent a second set of surveys (Time 0).

6 months after their practitioner's course completion, patients will be sent their next set of surveys (Follow Up 1).

6 months after the distribution of Follow Up Survey 1, patients will be sent their next set of surveys (Follow Up 2).

6 months after the distribution of Follow Up Survey 2, patients will be sent their next set of surveys (Follow Up 3).

6 months after the distribution of Follow Up Survey 3, patients will be sent their final set of surveys (Follow Up 4).

Practitioner measures:

* Demographics
* HC-PAIRS
* Mini Z \& Burnout
* PABS-PT
* Skills Comparison
* Multi-Disc Perspective Questionnaire
* CPPP (for MDs/DOs)
* Know Pain-12

Patient measures:

* Demographics
* Medication information
* PEG-3
* PCS
* PROMIS 8A
* PROMIS Global Health
* PROMIS Pain Interference
* GAD-7
* PHQ-8
* Secondary measures abstracted from state prescribing records

Practitioner interventions:

4PCP training course

Patient interventions:

No direct interventions, but concepts practitioners learn from the 4PCP curriculum may change the way the practitioner continues care with the patient.

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-blinded, stepped cluster design trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

4PCP Course

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

SSM Health

OTHER

Sponsor Role collaborator

Wisconsin Research and Education Network

NETWORK

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Chelimsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

VCU

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Wisconsin Research and Education Network (WREN)

Madison, Wisconsin, United States

Site Status RECRUITING

SSM Health

Madison, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Thomas Chelimsky, M.D.

Role: CONTACT

(804)-628-0145

Madison Maxwell, B.S.

Role: CONTACT

Facility Contacts

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Jeff Janata, M.D.

Role: primary

Mary Henningfield, PhD

Role: primary

Al Musa, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23459398 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 18661191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29768305 (View on PubMed)

Other Identifiers

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R01HS028630

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

HM20025110

Identifier Type: -

Identifier Source: org_study_id

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