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NCT Number: NCT05580419

Impact of 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Cleveland, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

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

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

    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.

  3. Number of Patient Participants whose opioid dose tapered

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

    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.

Secondary outcomes

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

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

    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.

  2. Change in Patient Participant Pain Interference (PI)

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  9. Practitioner Burn-Out

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Maxwell, B.S.

CONTACT

[email protected]

Thomas Chelimsky, M.D.

CONTACT

[email protected]

(804)-628-0145

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Case Western Reserve University
  • Medical College of Wisconsin
  • SSM Health
  • Wisconsin Research and Education Network

Registry information

Official study title

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

Acronym: 4PCP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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