Impact of 4PCP on Practitioner and Patient Outcomes

Chronic Pain Clinical Trial

— 4PCP  

Official title:

Impact of a Novel Community-Based Biobehavioral Chronic Pain Team Training Program (4PCP) on Practitioner and Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580419
• Other study ID #: HM20025110
• Secondary ID: R01HS028630
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: October 2027

Study information

• Verified date: July 2023
• Source: Virginia Commonwealth University
• Contact: Thomas Chelimsky, M.D.
• Phone: (804)-628-0145
• Email: thomas.chelimsky[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1188
• Est. completion date: October 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 4PCP Course
4PCP is a training framework for the management of chronic pain and gives practitioners lasting knowledge on how to better care for chronic pain patients.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio
United States	SSM Health	Madison	Wisconsin
United States	Wisconsin Research and Education Network (WREN)	Madison	Wisconsin
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Agency for Healthcare Research and Quality (AHRQ), Case Western Reserve University, Medical College of Wisconsin, SSM Health, Wisconsin Research and Education Network

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)	Pain, Enjoyment of Life and General Activity will be assessed using the PEG-3 which is a self-report, 3 item survey which asks patient participants to rate their experiences on a 10 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Primary	Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)	Practitioner chronic pain perspectives will be assessed using the CPPP, which is a self-report 26 item survey that asks practitioners to rate feelings related chronic pain on a 6 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Primary	Number of Patient Participants whose opioid dose tapered	Opioid Morphine milligram equivalents (MME) MME will be calculated from medical record/state prescription monitoring data to determine changes in patient opioid use. Based on MME changes, number of patients whose dose is tapered by at least 5% over 6 months will be counted.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Patient Participant Pain Catastrophizing Scale (PCS)	Pain catastrophization will be assessed using the PCS which is a self-report, 13 item survey which asks participants to rate how often they have the thoughts and feelings described in each item when they are in pain on a 5 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Patient Participant Pain Interference (PI)	PI will be assessed using the PROMIS Pain Interference - Short Form 8a which is a self-report, 8 item survey which asks participants to rate the degree to which pain interfered in their lives on a 5-point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Patient Participant Quality of Life (QoL)	QoL will be assessed using the PROMIS Global Health Scale which is a self-report, 10 item survey which asks participants to rate their perception of their physical and mental health on a 5-point Likert Scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Patient Participant Generalized Anxiety Disorder (GAD-7)	Anxiety levels will be assessed using the GAD-7 which is a self-report, 8 item survey which asks participants to rate how often they have the thoughts/feelings/behaviors described in each item on a 4 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Patient Participant Patient Health Questionnaire (PHQ-9)	Patient Health will be assessed using the PHQ-9 which is a self-report, 10 item survey which asks participants to rate how bothered they have been by physical/mental symptoms on a 4-point Likert Scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Practitioner Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS)	Practitioner pain and impairment relationship will be assessed using HC-PAIRS, which is a self-report 15 item survey that asks practitioners to answer questions about their perception on the abilities of chronic pain patients on a 7 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Practitioner Chronic Pain Attitudes and Beliefs Questionnaire (PABS-PT)	Practitioner career perspectives of chronic pain knowledge will be measured with the PABS-PT, which is a self-report 14 item survey that asks practitioners to rate their attitudes and beliefs on chronic pain care on a 6 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Change in Practitioner Burn-Out (Mini Z)	Practitioner career burn-out perception will be assessed using the Mini Z scale, which is a self-report 10 item survey that asks practitioners to rate feelings related to burn-out on a 5 point Likert scale. This measure differs from the Burn-Out measure in Outcome 7 because it includes the addition of questions relating to workplace environment.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Secondary	Practitioner Burn-Out	Practitioner career burn-out perception will be assessed using the Practitioner Burn-Out scale, which is a self-report 3 item survey that asks practitioners to rate feelings related to burn-out on a 10 point Likert scale.	Upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation