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IIR 10-128 – HSR&D Study

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IIR 10-128
Care Management for the Effective Use of Opioids (CAMEO)
Matthew J. Bair MD MS
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, IN
Funding Period: August 2011 - December 2015

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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

METHODS:
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.

FINDINGS/RESULTS:
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)

IMPACT:
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.

PUBLICATIONS:

Journal Articles

  1. Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. Journal of affective disorders. 2020 Apr 1; 266:100-108.
  2. Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. The journal of pain : official journal of the American Pain Society. 2019 Jun 1; 20(6):664-675.
  3. Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr 1; 159(4):775-782.
  4. Midboe AM, Lewis ET, Paik MC, Gallagher RM, Rosenberg JM, Goodman F, Kerns RD, Becker WC, Trafton JA. Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain. Translational behavioral medicine. 2012 Mar 1; 2(1):57-64.
Journal Other

  1. Bair MJ, Outcalt SD, Slaven JE, Kroenke K, Kempf C, Zillich AJ, Damush TM, Saha C, French DD, Krebs EE. Care Management for the Effective Use of Opioids (CAMEO): A Randomized Trial. Abstracts of the 77th Annual Scientific Meeting, March 6-9, 2019. Vancouver, BC, Canada. Abstract 1734. [Abstract]. Psychosomatic medicine. 2019 May 1; 81(4):A-149.
HSR&D or QUERI Articles

  1. Bair MJ. Research Highlight: Treatments for Veterans with Chronic Low Back Pain: The CAMEO Trial. Forum. 2016 May 1; page 7.
Conference Presentations

  1. Haibach JP, Moin T, Outcalt SD, Kerns RD. Chronic Condition Management and Prevention among Veterans. Presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2016 Mar 31; Washington, DC.
  2. Gallagher RM, Polomano RC, Buckemaier CC, Williams YS, Farrar JT, Guo W, Oslin DW. A longitudinal investigation of major combat limb injuries: the Regional Analgesia Military Battlefield Pain Outcomes Study (RAMBPOS). Poster session presented at: American Academy of Pain Medicine Annual Meeting; 2013 Apr 11; Fort Lauderdale, FL.


DRA: Other Conditions
DRE: Treatment - Comparative Effectiveness
Keywords: Comparative Effectiveness, Functional Status, Outcomes - Patient, Substance Use and Abuse
MeSH Terms: none

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