Care Management for the Effective Use of Opioids (CAMEO)
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|ClinicalTrials.gov Identifier: NCT01236521|
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Pain||Drug: Analgesic and co-analgesic therapy Behavioral: Pain self-management/coping skills treatment||Not Applicable|
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.
The investigators' 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
- To compare the interventions' (PHARM vs. BEH) effects on pain intensity and function at 6 months (primary end point) and 12 months (sustained effect)
To compare the interventions' effects (PHARM vs. BEH) on other relevant outcomes
- Patient global impression of change
- Health-related quality of life
- Opioid dose
- To compare the cost-effectiveness of the interventions
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Care Management for the Effective Use of Opioids (CAMEO)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Arm 1: Pharmacological (PHARM)
Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants will have an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. Patients' opioids will be adjusted and/or co-analgesics (or adjuvants) will be initiated. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. Follow-up NCM telephone contacts will occur at 2 and 4 weeks after baseline, and months 2, 3, 4, 6, and 9 months. On average, these calls last between 10 to 20 minutes. Detailed logs will be kept of the timing and content of patient contacts.
Drug: Analgesic and co-analgesic therapy
During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling.
The Patients in the PHARM arm will be asked to sign an opioid treatment agreement at enrollment.
Experimental: Arm 2: Behavioral treatment (BEH)
Veterans randomized to behavioral treatment arm (BEH) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Since optimal application of non-pharmacological interventions for pain involves tailoring to patient needs, participants will be introduced to a menu of self-management and coping skills rather than receive a prescribed program. Delivery of the behavioral intervention will employ a flexible approach that is easily adapted to individual preferences and perceived need for learning specific pain coping skills. Tailoring will include the selection of relevant content and skills and assessment of readiness to change behaviors.
Behavioral: Pain self-management/coping skills treatment
There will be 8 sessions that will last a maximum of 45-minutes to optimize participants' attentiveness and performance required by the cognitive demands of pain coping skills training. Each session will adhere to a common structure organized into three parts: 1) check-in; 2) intervention, and 3) wrap-up. Prior to each session participants will be asked to rate the strength and perceived impact for up to four pain beliefs that participants and the psychologist identified together. The sessions will occur during the scheduled clinical contacts (by telephone or face-to-face depending on patient preferences) at: with one week of baseline, 2 and 4 weeks, and months 2, 3, and 4 and skills reinforced at months 6 and 9. The content of these sessions are designed to modify coping strategies found to be related to pain and disability. Briefly, patients will be trained in a variety of evidence-based skills found to help reduce pain and improve function.
- Brief Pain Inventory (BPI), includes BPI pain intensity score, BPI pain interference score and Roland Disability Scale [ Time Frame: 12 months ]
- Psychological distress (PHQ-9, GAD-7 Anxiety, VA PTSD Screener, AUDIT-C [ Time Frame: at baseline, 3, 6, 6 9 and 12 months ]
- Opioid Misuse - Current Opioid Misuse Measure (COMM) [ Time Frame: at baseline, 3, 6, 9 and 12 months ]
- Generic HRQL (SF-12) measure of health status [ Time Frame: at baseline, 6 and 12 months ]
- Pain Beliefs (Pain Catastrophizing Scale) [ Time Frame: at baseline, 6 and 12 months ]
- Patient Global Rating of Change (PGIC) [ Time Frame: at baseline, 3, 6, 9 and 12 months ]
- Opioid Dose [ Time Frame: at baseline, 6 and 12 months ]
- Back Function (Functional Improvement) [ Time Frame: at baseline, 6 and 12 months ]
- Social Support Questionnaire (SSQ6) [ Time Frame: at baseline ]
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): NCT01236521
|United States, Indiana|
|Richard L. Roudebush VA Medical Center, Indianapolis, IN|
|Indianapolis, Indiana, United States, 46202-2884|
|Principal Investigator:||Matthew J. Bair, MD MS||Richard L. Roudebush VA Medical Center, Indianapolis, IN|