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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS028630 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
| Case Western Reserve University | OTHER |
| SSM Health | OTHER |
| Wisconsin Research and Education Network |
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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.
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:
Patient measures:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4PCP Course (for practitioners only) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4PCP Course | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Practitioner Inclusion:
Patient inclusion:
Practitioner exclusion:
Patient exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Chelimsky, M.D. | Contact | (804)-628-0145 | thomas.chelimsky@vcuhealth.org | |
| Madison Maxwell, B.S. | Contact | madison.maxwell@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Chelimsky, M.D. | VCU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Not yet recruiting | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23459398 | Background | 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. | |
| Background | 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 | ||
| 18661191 |
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Only de-identified aggregate data will be shared with other researchers.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NETWORK |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Single-blinded, stepped cluster design trial
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
| Wisconsin Research and Education Network (WREN) | Recruiting | Madison | Wisconsin | 53715 | United States |
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| SSM Health | Not yet recruiting | Madison | Wisconsin | 53716 | United States |
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| Background |
| 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. |
| 29768305 | Background | 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. |