Clinical trial NCT05580419: Impact of 4PCP on Practitioner and Patient Outcomes
Official title: Impact of a Novel Community-Based Biobehavioral Chronic Pain Team Training Program (4PCP) on Practitioner and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: Case Western Reserve University
name: SSM Health
name: Wisconsin Research and Education Network
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-10-14
Enrollment: 1188
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-blinded, stepped cluster design trial
Primary purpose: OTHER

Brief 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. 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.

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

Primary outcomes:
measure: Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Number of Patient Participants whose opioid dose tapered
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary outcomes:
measure: Change in Patient Participant Pain Catastrophizing Scale (PCS)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Patient Participant Pain Interference (PI)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Patient Participant Quality of Life (QoL)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Patient Participant Generalized Anxiety Disorder (GAD-7)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Patient Participant Patient Health Questionnaire (PHQ-9)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Practitioner Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Practitioner Chronic Pain Attitudes and Beliefs Questionnaire (PABS-PT)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Change in Practitioner Burn-Out (Mini Z)
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
measure: Practitioner Burn-Out
timeFrame: Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Madison
country: United States
facility: Wisconsin Research and Education Network (WREN)
state: Wisconsin
city: Madison
country: United States
facility: SSM Health
state: Wisconsin
Study officials:
affiliation: VCU
name: Thomas Chelimsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.