Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts
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|ClinicalTrials.gov Identifier: NCT02484937|
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : April 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Chronic Pain Pain, Intractable||Other: Group 2 (PCP Treatment) Other: Group 1 (PMS Treatment)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Functional Outcomes and Lowering Health Care Costs by Enhanced Integration of Primary Care Providers and Pain Medicine Physicians for Chronic Non-cancer Pain Patients|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Group 1 (PMS Treatment)
Subjects will be treated monthly for 6 months by Pain Medicine Specialist (PMS) per standard protocol. The PCP will not be involved in the treatment.
Other: Group 1 (PMS Treatment)
For the PMS group treatment will be performed (pain treatment/medications) by the Pain Medicine Specialist in his/her office/clinic.
Experimental: Group 2 (PCP Treatment)
Subjects will be treated monthly for 6 months by the Primary Care Provider (PCP).The PCP will be involved and a multimodal therapeutic strategy will be communicated to the PCP by the PMS. The PCP will make dosage based on an algorithm provided by the PMS on how to adjust drug doses over time. It is not intended that the PCP may have ongoing engagement with the PMS. A direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns.
Other: Group 2 (PCP Treatment)
For the PCP group treatment will be performed (pain treatment/medications) by the Primary Care Physician in his/her office/clinic.
- Pain interference with daily activity - BPI score change from baseline. [ Time Frame: 6 months ]
The Brief Pain Inventory (BPI) short form is a self-report questionnaire using items (questions) on a 11-point scale (0-10), and will be used to assess impact of pain on daily activities, and pain severity.
We will gather data approximately on a monthly basis (Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month).
- Procedural variations [ Time Frame: 6 months ]A data integration clinical coordinator (DICC), not blinded to group allocation, will query electronic and physical health records, from both the PCP and PMS
- Functional health and well-being - improvement from baseline [ Time Frame: 6 months ]The Short Form-36 Health Survey (SF-36) form is a health-related quality of lif questionnaire which measures two different health domains: physical health (including bodily pain) and mental health, as well as further division into more specific subscales.
- Patients experience of care [ Time Frame: 6 months ]The Patient Satisfaction Questionnaire (PSQ-18) assesses global satisfaction with medical care as well as satisfaction with six aspects of care: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility of care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484937
|Contact: Mario Moricfirstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Mario Moric 312-942-2806 email@example.com|
|Principal Investigator: Asokumar Buvanendran, M.D.|
|Principal Investigator:||Asokumar Buvanendran, MD||Rush University Medical Center|