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4PCP Training for Chronic Pain (4PCP Trial)
N/A
Recruiting
Led By Thomas Chelimsky, M.D.
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English literate patients with chronic non-malignant pain > 3 months > 3/10 > 50% of the time, with no foreseeable or planned surgical solution
Must not have
Non-English speaking patients
Practitioners not able to fully answer questionnaires and participate in training and evaluations in the research study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to improve chronic pain treatment & outcomes for all, potentially at a lower cost. A startup will provide the program & results will show if it works.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves an educational course rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect effects related to changes in pain management practices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic pain for over 3 months, with no surgery planned.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
Select...
I am unable to complete questionnaires or participate in study training and evaluations.
Select...
I am unable to complete questionnaires due to a condition like stroke or dementia.
Select...
I have sickle cell disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)
Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)
Number of Patient Participants whose opioid dose tapered
Secondary study objectives
Change in Patient Participant Generalized Anxiety Disorder (GAD-7)
Change in Patient Participant Pain Catastrophizing Scale (PCS)
Change in Patient Participant Pain Interference (PI)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 4PCP Course (for practitioners only)Experimental Treatment1 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.
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,887,310 Total Patients Enrolled
4 Trials studying Chronic Pain
3,921 Patients Enrolled for Chronic Pain
Medical College of WisconsinOTHER
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1,180,521 Total Patients Enrolled
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39 Patients Enrolled for Chronic Pain
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
250,071 Total Patients Enrolled
4 Trials studying Chronic Pain
4,291 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.Doctors who work in general medicine (such as for adults or families) or in women's health.I am unable to complete questionnaires or participate in study training and evaluations.I have visited this medical practice at least twice before.I have had chronic pain for over 3 months, with no surgery planned.I am between 14 and 80 years old and speak English.I am unable to complete questionnaires due to a condition like stroke or dementia.I have sickle cell disease.You are not a doctor who focuses on general healthcare for patients.You are being treated for pain by a specialist, not your regular doctor.
Research Study Groups:
This trial has the following groups:- Group 1: 4PCP Course (for practitioners only)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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