Impact of 4PCP on Practitioner and Patient Outcomes

Virginia Commonwealth University (VCU) logo

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

This is a single-blinded, stepped cluster design trial, assessing whether a training intervention for primary care teams using the 4PCP biobehavioral framework to manage chronic pain in the community, improves patient outcomes, enhances practice satisfaction and alters opioid prescribing. There was brief consideration in utilizing practitioners from the same practices uninterested in 4PCP as comparison, since they could be compared throughout the duration of the trial. However, it was reasoned this would not be suitable for 2 reasons. First, they are not comparable to practitioners interested in 4PCP, and their lack of interest might falsely increase the apparent benefit of the intervention, not because of the value of the intervention, but because practitioners in the comparison group are just less interested in chronic pain management. Second, contamination between the study and comparison groups might occur through hall conversations. Therefore, a stepped design was selected, where each practice serves in part as their own control and in part as a control for other enrolled practices. The selection of this stepped cluster design was informed by the pilot 4PCP trial where loss of engagement of the practitioner group randomized to a control practitioner arm (due to the 1 year wait time for the intervention) occurred. Therefore, the time each practice serves as a comparison group without losing power by using the stepped cluster design was reduced, thus having multiple practices in a comparison arm at different times. Although there was an original envision of a true stepped wedge design, this would have required more frequent measurements than the resources of the current funding mechanism allow. The current stepped cluster design provides solid power to determine the impact of 4PCP on both patients and practitioners. The trial is single-blinded (investigators blinded to the origin of physician and patient measures) as it is not possible to devise a sham that will truly blind practitioners to a such an intensive training intervention. Practitioner procedures: After practitioners enroll via phone or Zoom, they will be sent a set of surveys through REDcap to their phone or email to complete before the 4PCP training course. They will then choose a time to complete their course. Course time options will be sent via email. Before training, practitioners will view background videos and complete journal exercises associated with the videos. Journal data will not be collected- this is only to get the provider thinking about the topic. Closer to the date of course attendance, practitioners will be sent the same set of surveys they completed at baseline (Time 0). Training is set up so that every 2 months grant faculty will train a set of 3 practices through video-conferencing (Zoom). They will also be sent information on a monthly case conference. This discussion will be open and virtual (Zoom) with no data collected, only to apply 4PCP to examples of real-life cases. Approximately 6 to 12 months after the course for up to 3 years after the course, practitioners will be sent this same set of surveys. Study staff will send a reminder once a month if the survey is not completed via email or text. At the conclusion of their participation, ideally they will have answered all surveys, but practitioners are free to skip any surveys or questions they want. Compensation will be processed immediately after completion of the surveys, which will be set up so REDcap notifies a research staff member via email upon completion. Patient procedures: After patients enroll via phone or Zoom, they will be sent a set of surveys through REDcap to their phone or email (see below for specific measures) to complete before their provider completes the 4PCP training course. Closer to the date of the practitioner's course attendance, they will complete a second set of baseline surveys (Time 0). Approximately 6 to 12 months after the practitioner completes the course for up to 3 years after, patients will be sent this same set of surveys that they completed at baseline. Study staff will send a reminder once a month if the survey is not completed via email or text. At the conclusion of their participation, ideally they will have answered all surveys, but patients are free to skip any surveys or questions they want. Compensation will be processed immediately after completion of the surveys, which will be set up so REDcap notifies a research staff member via email upon completion. Practitioner measures: Demographics, Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS), Mini Z & Burnout, Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT), Multi-Disc Perspective Questionnaire, Chronic Pain Physician Perspectives, Skills Comparison, Know Pain-12 Practitioner interventions: 4PCP training course Patient measures: Demographics declined survey (if declined to participate), Demographics (for enrolled participants), Pain, Enjoyment of Life and General Activity (PEG-3), Pain Catastrophizing Scale (PCS), Patient-Reported Outcomes Measurement Information System (PROMIS) 8A - Pain Interference, PROMIS Global Health, Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9), Medication Information (self-reported), & secondary measures abstracted from state prescribing records. Patient interventions: None - only research responsibility as a patient participant is completion of the surveys. As practitioners implement new skills learned from the 4PCP course, patients may observe changes in that practitioner's approach to their chronic pain care.

Enrollment

1,188 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Practitioner Inclusion: Participants must be practitioners in primary care (internal medicine, family practice, gynecology, etc.) Participants must have their own identifiable patient population including patients with chronic pain if they are a physician or Advanced Practice Provider (APP) Participants must be able to fully answer questionnaires and participate in training and evaluations in the research study. English speaking Patient inclusion: Ages 14-80 years English literate Chronic non-malignant pain > 3 months > 3/10 > 50% of the time, with no foreseeable or planned surgical solution. They must have been a patient in the practice across 2 established visits (to avoid "doctor shopping" and maximize likelihood of meaningful follow-up in the study). Practitioner exclusion: Participants are not in primary care (internal medicine, family practice, gynecology, etc.) Participants are not able to fully answer questionnaires and participate in training and evaluations in the research study. Non-English speaking Patient exclusion: Inability 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

4

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Central trial contact

Madison Maxwell, B.S.; Thomas Chelimsky, M.D.

Data sourced from clinicaltrials.gov

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