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Chronic Pain4PCPNCT05580419

Impact of 4PCP on Practitioner and Patient Outcomes

A study testing 4PCP Course in people with Chronic Pain, run by Virginia Commonwealth University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 80 years
Conditions the study is for
Chronic Pain
What is being tested?
4PCP Course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,188 participants
Where
4 sitesUnited States
Study dates
17 Mar 2023to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Wisconsin Research and Education Network (WREN)

    Madison, Wisconsin, 53715

  • SSM Health

    Madison, Wisconsin, 53716

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Impact of a Novel Community-Based Biobehavioral Chronic Pain Team Training Program (4PCP) on Practitioner and Patient Outcomes

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.

Read the detailed description

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
Chronic Pain
Being tested
4PCP Course
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4PCP CourseBehavioural

    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 groups in NCT05580419
Study groupRoleWhat they receive
4PCP Course (for practitioners only)ExperimentalAll 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.
Receives: Behavioral: 4PCP Course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)

    Pain, Enjoyment of Life and General Activity will be assessed using the PEG-3 which is a self-report, 3 item survey which asks patient participants to rate their experiences on a 10 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  2. Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)

    Practitioner chronic pain perspectives will be assessed using the CPPP, which is a self-report 26 item survey that asks practitioners to rate feelings related chronic pain on a 6 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  3. Number of Patient Participants whose opioid dose tapered

    Opioid Morphine milligram equivalents (MME) MME will be calculated from medical record/state prescription monitoring data to determine changes in patient opioid use. Based on MME changes, number of patients whose dose is tapered by at least 5% over 6 months will be counted.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

Secondary outcomes (9)

  1. Change in Patient Participant Pain Catastrophizing Scale (PCS)

    Pain catastrophization will be assessed using the PCS which is a self-report, 13 item survey which asks participants to rate how often they have the thoughts and feelings described in each item when they are in pain on a 5 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  2. Change in Patient Participant Pain Interference (PI)

    PI will be assessed using the PROMIS Pain Interference - Short Form 8a which is a self-report, 8 item survey which asks participants to rate the degree to which pain interfered in their lives on a 5-point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  3. Change in Patient Participant Quality of Life (QoL)

    QoL will be assessed using the PROMIS Global Health Scale which is a self-report, 10 item survey which asks participants to rate their perception of their physical and mental health on a 5-point Likert Scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  4. Change in Patient Participant Generalized Anxiety Disorder (GAD-7)

    Anxiety levels will be assessed using the GAD-7 which is a self-report, 8 item survey which asks participants to rate how often they have the thoughts/feelings/behaviors described in each item on a 4 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  5. Change in Patient Participant Patient Health Questionnaire (PHQ-9)

    Patient Health will be assessed using the PHQ-9 which is a self-report, 10 item survey which asks participants to rate how bothered they have been by physical/mental symptoms on a 4-point Likert Scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  6. Change in Practitioner Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS)

    Practitioner pain and impairment relationship will be assessed using HC-PAIRS, which is a self-report 15 item survey that asks practitioners to answer questions about their perception on the abilities of chronic pain patients on a 7 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  7. Change in Practitioner Chronic Pain Attitudes and Beliefs Questionnaire (PABS-PT)

    Practitioner career perspectives of chronic pain knowledge will be measured with the PABS-PT, which is a self-report 14 item survey that asks practitioners to rate their attitudes and beliefs on chronic pain care on a 6 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  8. Change in Practitioner Burn-Out (Mini Z)

    Practitioner career burn-out perception will be assessed using the Mini Z scale, which is a self-report 10 item survey that asks practitioners to rate feelings related to burn-out on a 5 point Likert scale. This measure differs from the Burn-Out measure in Outcome 7 because it includes the addition of questions relating to workplace environment.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

  9. Practitioner Burn-Out

    Practitioner career burn-out perception will be assessed using the Practitioner Burn-Out scale, which is a self-report 3 item survey that asks practitioners to rate feelings related to burn-out on a 10 point Likert scale.

    Measured: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start17 Mar 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-blinded, stepped cluster design trial
Masking
None (open label)
Enrolment
1,188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580419
Sponsor's protocol ID
HM20025110
Other IDs
R01HS028630
Acronym
4PCP
Status last verified
Sep 2026
First submitted
11 Oct 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only de-identified aggregate data will be shared with other researchers.

Publications

  • 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.

    PubMed 23459398

  • 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

  • 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.

    PubMed 18661191

  • 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.

    PubMed 29768305

Questions about this trial

What is this clinical trial studying?

A study testing 4PCP Course in people with Chronic Pain, run by Virginia Commonwealth University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580419, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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