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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Brief Summary:
This study will demonstrate that functional improvement measures over a 6-month period for chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those under the care of the PMS only. Chronic low back pain patient will be initially be evaluated by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will be treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by their own PCP for monthly visits for 6 months.

Condition or disease Intervention/treatment Phase
Back Pain Chronic Pain Pain, Intractable Other: Group 2 (PCP Treatment) Other: Group 1 (PMS Treatment) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Non-structural non-specific chronic low back pain of a least 3 months duration

2.18 years of age or older

3.Has a primary care provider (PCP)

Exclusion Criteria:

  1. Unable to communicate with health care providers
  2. Refuses to complete the required outcome measures
  3. Unable to provide consent
  4. Advanced medical illness (severe systemic disease)
  5. Significant psychiatric history: a diagnosis of schizophrenia, bipolar disorder, or severe depression.
  6. History of psychosis or psychiatric hospitalization, suicidal ideation or attempt.

Information from the National Library of Medicine

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


Contacts
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Contact: Mario Moric 312-942-2806 mario_moric@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mario Moric    312-942-2806    mario_moric@rush.edu   
Principal Investigator: Asokumar Buvanendran, M.D.         
Sponsors and Collaborators
Rush University Medical Center
Pfizer
Investigators
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Principal Investigator: Asokumar Buvanendran, MD Rush University Medical Center
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Responsible Party: Asokumar Buvanendran, Professor, Department of Anesthesiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02484937    
Other Study ID Numbers: 14100602
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Keywords provided by Asokumar Buvanendran, Rush University Medical Center:
Pain management
Additional relevant MeSH terms:
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Chronic Pain
Pain, Intractable
Pain
Neurologic Manifestations