Impact of 4PCP on Practitioner and Patient Outcomes

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

4PCP Course

Clinical Study ID

NCT05580419

HM20025110

R01HS028630

Ages 14-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

4PCP Course

March 17, 2023

September 30, 2027

Study 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.

Connect with a study center

Case Western Reserve University
Cleveland, Ohio 44106
United States
Site Not Available
Case Western Reserve University
Cleveland 5150529, Ohio 5165418 44106
United States
Site Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Site Not Available
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23298
United States
Active - Recruiting
SSM Health
Madison, Wisconsin 53716
United States
Site Not Available
Wisconsin Research and Education Network (WREN)
Madison, Wisconsin 53715
United States
Site Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Site Not Available
SSM Health
Madison 5261457, Wisconsin 5279468 53716
United States
Site Not Available
Wisconsin Research and Education Network (WREN)
Madison 5261457, Wisconsin 5279468 53715
United States
Active - Recruiting

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