Menu
Recruiting NCT05580419

Impact of 4PCP on Practitioner and Patient Outcomes

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4PCP Course.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: 14 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
Secondary outcome measures (9)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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 Burn-Out [Time frame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 4 centers
  • Case Western Reserve University — Cleveland
  • Virginia Commonwealth University — Richmond
  • Wisconsin Research and Education Network (WREN) — Madison
  • SSM Health — Madison

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. PMID 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. PMID 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. PMID 29768305

Identifiers

NCT: NCT05580419 · HM20025110 · R01HS028630

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗