4PCP Training for Chronic Pain

(4PCP Trial)

Recruiting at 4 trial locations

Overseen By Madison Maxwell, B.S.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Sickle cell, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

1188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

How does the 4PCP Training treatment for chronic pain differ from other treatments?

The 4PCP Training for chronic pain is unique because it focuses on teaching patients pain management skills through a comprehensive program that includes exercise, relaxation, pacing, medication review, and cognitive strategies to challenge negative thoughts. This approach aims to prevent long-term negative behaviors associated with chronic pain by introducing these strategies early, which is different from treatments that primarily focus on medication or physical interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the 4PCP Training treatment for chronic pain?

The 4PCP Training treatment involves a collaboration between primary care physicians and pain specialists, which has been shown to improve chronic pain management by providing specialized training and support. Additionally, similar programs like the Pain Coping Strategies (PCS) programme have demonstrated benefits in teaching patients pain management skills, suggesting that structured training can be effective in managing chronic pain. ^{2 6 7 8 9}

Who Is on the Research Team?

Thomas Chelimsky, M.D.

Principal Investigator

VCU

Are You a Good Fit for This Trial?

This trial is for primary care practitioners with patients suffering from chronic pain, who can complete questionnaires and engage in a training program. It's also for English-speaking patients aged 14-80 with long-term non-cancer pain that's moderate to severe most of the time, without plans for surgery. Excluded are those unable to participate fully or answer questions due to conditions like dementia.

Inclusion Criteria

Doctors who work in general medicine (such as for adults or families) or in women's health.

Practitioners with their own identifiable patient population including patients with chronic pain if they are a physician or Advanced Practice Provider (APP)

I have visited this medical practice at least twice before.

Exclusion Criteria

Prisoners

I am unable to complete questionnaires or participate in study training and evaluations.

I am unable to complete questionnaires due to a condition like stroke or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Practitioners and patients complete baseline surveys after informed consent

1 week

1 visit (virtual)

4PCP Training Course

Practitioners participate in the 4PCP training course

Varies

Follow-up

Practitioners and patients complete follow-up surveys at multiple intervals to assess outcomes

Up to 3 years

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 4PCP Training

Trial Overview The study tests a course called '4PCP' designed to reduce opioid prescriptions and improve patient outcomes in chronic pain management. The effectiveness of this potentially cost-saving approach provided by PainSTakers, LLC will be evaluated on clinical outcomes, aiming later at proving economic benefits.

How Is the Trial Designed?

Group I: 4PCP Course (for practitioners only) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

SSM Health

Collaborator

Trials

2

Recruited

1,200+

Wisconsin Research and Education Network

Collaborator

Trials

1

Recruited

1,200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The 4PCP training program significantly improved primary care physicians' ability to diagnose and manage chronic pain, leading to better patient outcomes and increased treatment satisfaction, as evidenced by a decrease in visit time from 20 to 11 minutes.

Physicians who participated in the 4PCP program reported lasting benefits in their practice, with improvements in patient care persisting for at least one year after the training, highlighting the effectiveness of interdisciplinary collaboration in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary practice physician program for chronic pain (© 4PCP): outcomes of a primary physician-pain specialist collaboration for community-based training and support. Chelimsky, TC., Fischer, RL., Levin, JB., et al.[2013]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

A 4-week Pain Coping Strategies (PCS) program significantly improved mood, functional status, and physical ability in 31 chronic pain patients, as measured by standardized scales before and 6 weeks after the program.

The study suggests that early intervention with pain management strategies can effectively promote self-management and positive coping skills in chronic pain patients, even while they are undergoing other medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Mead, K., Theadom, A., Byron, K., et al.[2011]

The Chronic Pain Profile (CPP) was found to be clinically useful by pharmacists, with mean usefulness scores ranging from 66.6 to 80.9, indicating it can effectively help in managing pain and improving health outcomes.

Key themes identified included the CPP's ability to promote patient advocacy and save time in accessing pain information, but also highlighted limitations such as lack of customization and concerns about its complexity and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Mixed-Methods Study to Establish the Clinical Usefulness of a Chronic Pain Profile (CPP) for Pain Management. Axon, DR., Le, D., Chien, J.[2023]

The implementation of a chronic pain protocol (CPP) at a health center led to an 88% reduction in long-term opioid prescriptions by nurse practitioners, resulting in 97 fewer patients treated with long-term opioids over 12 months.

The protocol also increased the number of patients with pain management contracts by 22.9% and those undergoing urine drug screenings by 18.3%, indicating improved monitoring and adherence to safe opioid prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a standardized approach for managing opioids in adults with chronic noncancer pain. Downes, JM., Klepser, DG., Foster, J., et al.[2019]

The Mindfulness-Based Chronic Pain Management (MBCPM) program showed feasibility in a study with 31 veterans, leading to significant improvements in pain catastrophizing scores, indicating better coping strategies, although pain intensity itself did not significantly change.

Qualitative feedback from participants highlighted feelings of connection, increased awareness, and a sense of control, suggesting that the program may enhance overall quality of life for veterans dealing with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. Chen, SP., Liu, HT., Appelt, JC., et al.[2023]

Chronic pain is a widespread issue that significantly affects people's quality of life, yet it is often not prioritized in the education of future healthcare professionals.

The authors propose educational strategies based on international guidelines to better prepare health science students for managing chronic pain, emphasizing the need for a comprehensive approach in their training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dealing with Chronic Pain: Tips to Teach Undergraduate Health Sciences Students. Hernández-Sánchez, S., Poveda-Pagán, EJ., Toledo-Marhuenda, JV., et al.[2022]

The VA's cognitive behavioral therapy for chronic pain (CBT-CP) has shown significant effectiveness in improving various patient outcomes, including pain intensity and quality of life, based on a review of 1,331 Veterans treated from 2012 to 2018.

Patients experienced large reductions in pain catastrophizing (Cohen's d = 0.78) and medium to large improvements in other areas such as depression and physical quality of life, indicating that CBT-CP is a safe and effective nonpharmacological treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. Murphy, JL., Cordova, MJ., Dedert, EA.[2023]

The self-directed learning module provides practitioners with strategies for interventional treatments specifically targeting chronic pain disorders, focusing on recalcitrant buttock and hip pain.

It outlines various interventional protocols, including injections, neuroablative lesioning, and implantable treatments like spinal cord stimulation, emphasizing their roles in managing intractable pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions in chronic pain management. 6. Interventional approaches to chronic pain management. Overton, EA., Kornbluth, ID., Saulino, MF., et al.[2013]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The primary practice physician program for chronic pain (© 4PCP): outcomes of a primary physician-pain specialist collaboration for community-based training and support. [2013]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Mixed-Methods Study to Establish the Clinical Usefulness of a Chronic Pain Profile (CPP) for Pain Management. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Development of a standardized approach for managing opioids in adults with chronic noncancer pain. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Dealing with Chronic Pain: Tips to Teach Undergraduate Health Sciences Students. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Interventions in chronic pain management. 6. Interventional approaches to chronic pain management. [2013]