Care Management for the Effective Use of Opioids (CAMEO)
Tracking Information | |||||||||
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First Received Date ICMJE | November 5, 2010 | ||||||||
Last Updated Date | August 3, 2012 | ||||||||
Start Date ICMJE | December 2011 | ||||||||
Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Brief Pain Inventory (BPI), includes BPI pain intensity score, BPI pain interference score and Roland Disability Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE |
Brief Pain Inventory (BPI), includes BPI pain intensity score, BPI pain interference score and Roland Disability Scale [ Time Frame: at baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ] | ||||||||
Change History | Complete list of historical versions of study NCT01236521 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Care Management for the Effective Use of Opioids | ||||||||
Official Title ICMJE | Care Management for the Effective Use of Opioids (CAMEO) | ||||||||
Brief Summary | The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are: 1) to compare the interventions' (PHARM vs. BEH) effects on pain intensity, function, and other pain relevant outcomes at 6 months (primary end point) and 12 months (sustained effect); and 2) to compare the cost-effectiveness of the interventions |
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Detailed Description | The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP. Our study sample will include 450 veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (PHARM). Patients in the behavioral arm (BEH) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months. Study Aims: Among veterans with chronic low back pain refractory to long-term opioid therapy
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Intervention ICMJE |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 450 | ||||||||
Estimated Completion Date | July 2015 | ||||||||
Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Veterans will be eligible if they have:
Exclusion Criteria: Exclusion criteria includes:
We will exclude veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability we will not exclude those with a past history of substance abuse. |
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01236521 | ||||||||
Other Study ID Numbers ICMJE | IIR 10-128 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Department of Veterans Affairs | ||||||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
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Investigators ICMJE |
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Information Provided By | Department of Veterans Affairs | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |