Impact of 4PCP on Practitioner and Patient Outcomes

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: 4PCP Course

Study type: Interventional

Funder types: Other; NETWORK; Other U.S. Federal agency

Identifiers

NCT05580419

R01HS028630 (Other Grant/Funding Number)

HM20025110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,188 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,188 participants in 1 patient group

4PCP Course (for practitioners only)

Experimental group

Description:

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.

Treatment:

Behavioral: 4PCP Course