HSR&D Home » Research » IIR 10-128 – HSR&D Study
Care Management for the Effective Use of Opioids (CAMEO)
Matthew J. Bair, MD MS
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Funding Period: August 2011 - December 2015
Chronic pain is a major public health problem. More than 70 million Americans suffer from chronic pain and 50 million of them are disabled by pain. Chronic pain affects 40%-70% of veterans and is a leading cause of disability, resulting in substantial negative impact on millions of veterans' lives. Chronic pain costs more than $100 billion per year in medical expenses, lost wages, and other costs. Musculoskeletal pain is especially common, accounting for two-thirds of all primary care visits for pain, and chronic low back pain (CLBP) is the most prevalent, disabling, and costly.
Many options are available to treat CLBP, yet management is difficult because of the lack of consensus to guide clinician decisions. Analgesic medications remain the first line of treatment, but providers often do not use the entire array of analgesics that have been shown to be efficacious in CLBP. For non-pharmacological treatments, the strongest trial evidence is for those which use cognitive or behavioral approaches. Despite this evidence, primary care settings have not routinely implemented non-pharmacological treatments for CLBP because of time constraints, lack of provider knowledge, and limited personnel to deliver non-pharmacological treatments. However, the recent integration of psychologists into VA primary care settings increases the feasibility of administering non-pharmacological interventions.
Use of opioid analgesics has increased both outside and within the VA for many pain conditions, including CLBP. While some pain experts view this trend as evidence of improved pain treatment, others have equated this practice to "flying blind," given the paucity of trials evaluating the effectiveness and safety of opioids. Many patients continue to experience severe, disabling pain despite opioid treatment; others report intolerable side effects from opioids. Primary care providers often struggle with opioid treatment decisions and worry about fostering prescription drug abuse and addiction. Given these controversies, struggles, and lack of convincing data for opioid use, research to compare pharmacological and non-pharmacological treatments to improve the management of CLBP, especially for veterans on long-term opioid therapy, is urgently needed.
The CAre Management for the Effective use of Opioids (CAMEO) trial was a 2-arm randomized clinical trial that compared the effectiveness of pharmacological (PHARM) vs. behavioral (BEH) approaches for chronic lower back pain (CLBP). The study aims were: 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
Our study sample included veterans with moderate to severe chronic lower back pain (CLBP) despite long-term opioid therapy. Patients from the five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics were recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm involved guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (PHARM). Patients in the behavioral arm (BEH) received pain coping/self-management skills training. The trial lasted 12-months and all participants underwent comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months. There were also brief physical assessment at baseline and 6 months.
A nurse care management intervention focused on pharmacological management reduced pain impact, severity, and interference more than a behavioral intervention involving cognitive behavioral therapy.
- Descriptive information of the sample
o Mean age (57.9 SD = 9.5 years)
o Percent male and female (92.3% males, 7.7% females)
o Race/Ethnicity (1.5% American Indian, 0% Asian, 0% Hawaiian or other
pacific islander, 20.7% Black or African American, 73.2% White, 0.8% more
than 1 race, 3.8% unknown or not reported)
Given the rising prevalence of chronic lower back pain (CLBP) among veterans, the modest effectiveness of current treatments, and the burden chronic pain places on veterans and their primary care provider, this study is significant in several regards. First, the CAMEO trial addressed a high priority area for the VA and is well aligned with the VHA Pain Management Strategy, VHA Pain Directive, VA Primary Care-Mental Health Integration, and VA's Patient Centered Medical Home Initiative. Second, CAMEO provides information vital to begin filling an evidence vacuum regarding comparative effectiveness of treatments for chronic pain, especially in the primary care setting. Third, opioid prescribing is being scrutinized within and outside the VA. The study interventions tested provide evidence of alternatives to opioid therapy. Lastly, CAMEO extends our current understanding of pharmacological and behavioral approaches and which approach may prove more beneficial and effective.
External Links for this Project
NIH ReporterGrant Number: I01HX000495-01A1
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DRA: Other Conditions
DRE: Treatment - Comparative Effectiveness
MeSH Terms: none