Stepped Care to Optimize Pain Care Effectiveness (SCOPE)
Kurt Kroenke MD
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, IN
Funding Period: October 2009 - September 2013

BACKGROUND/RATIONALE:
Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.

OBJECTIVE(S):
The objectives of this study are to determine if: (a) Three Component Model (TCM) stepped care will be superior to usual care in improving pain-related disability: (b) TCM stepped care will be superior to usual care in improving secondary pain outcomes, including pain severity and global improvement of pain; and (c) TCM stepped care will be superior to usual care in improving other outcomes, specifically depression, anxiety, health-related quality of life, and satisfaction with treatment.

METHODS:
The study population consists of 250 primary care veterans between 18 and 65 years old who have musculoskeletal pain that is moderate in severity and is persistent for at least three months. Excluded will be individuals who: (a) have filed a pain-related disability claim in the past 6 months; (b) do not speak English; (c) have moderately severe cognitive impairment; (d) have schizophrenia, bipolar disorder, or other psychosis; (e) are actively suicidal; (f) have current illicit drug use; or (g) have an anticipated life expectancy of less than 12 months.

Study subjects will be randomized to the intervention arm or the usual care control arm. The intervention will be based upon the empirically-validated Three-Component Model, which in SCOPE will involve collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention will consist of optimized analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. Additionally, subjects with comorbid depression will be treated with evidence-based guidelines for depression management. All medications provided to subjects are FDA-approved and commonly administered in routine clinical practice for the conditions (pain and/or depression) being treated in this trial. Subjects in the usual care control group will receive standard treatments from their primary care physician (PCP) that the PCP would usually provide for pain. Outcome assessments will be conducted at baseline, 1, 3, 6, and 12 months by interviewers blinded to treatment arm for all study subjects.

FINDINGS/RESULTS:
Data collection began in May of 2010 and continues. Analysis has begun on 1 and 3 month interviews.

IMPACT:
Anticipated future directions for extending the impact of this research on health care within VHA include: (1) expand telecare pain management to specialty clinics such as oncology, rheumatology, and neurology, where pain is a substantial problem; (2) providing coverage for more than one VA facility, including multiple clinics within a region (e.g., a VISN); and (3) disseminating the medication algorithms, training manuals, and care manager resources to other VA Medical Center facilities.


PUBLICATIONS:

Journal Articles

1. Bair MJ, Poleshuck EL, Wu J, Krebs EK, Damush TM, Tu W, Kroenke K. Anxiety but not social stressors predict 12-month depression and pain severity. The Clinical journal of pain. 2013 Feb 1; 29:(2):95-101.
2. Burgess DJ, Gravely AA, Nelson DB, van Ryn M, Bair MJ, Kerns RD, Higgins DM, Partin MR. A national study of racial differences in pain screening rates in the VA health care system. The Clinical journal of pain. 2013 Feb 1; 29:(2):118-23.
3. Dobscha SK, Corson K, Helmer DA, Bair MJ, Denneson LM, Brandt C, Beane A, Ganzini L. Brief assessment for suicidal ideation in OEF/OIF veterans with positive depression screens. General hospital psychiatry. 2013 Jan 23.
4. Kroenke K, Krebs E, Wu J, Bair MJ, Damush T, Chumbler N, York T, Weitlauf S, McCalley S, Evans E, Barnd J, Yu Z. Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics. Contemporary clinical trials. 2012 Dec 8; 34:(2):270-281.
5. Matthias MS, Miech EJ, Myers LJ, Sargent C, Bair MJ. "There's more to this pain than just pain": how patients' understanding of pain evolved during a randomized controlled trial for chronic pain. The journal of pain : official journal of the American Pain Society. 2012 Jun 1; 13(6):571-8.
6. Kroenke K, Wu J, Bair MJ, Damush TM, Krebs EE, Tu W. Impact of depression on 12-month outcomes in primary care patients with chronic musculoskeletal pain. Journal of Musculoskeletal Pain. 2012 Jan 1; 20(1):8-17.

Conference Presentations

1. Dobscha SK, Corson K, Helmer D, Bair M, Denneson LM, Ganzini LK. Screening for Suicidal Ideation in VA Ambulatory Settings. Paper presented at: Academy of Psychosomatic Medicine Annual Meeting; 2011 Nov 19; Phoenix, AZ.
2. Matthias MS, Bergman AB, Krebs E, Bair MJ, Coffing JM, Collins LA. "I'm not abusing or anything": Patient provider communication about opioid treatment. Paper presented at: International Conference on Communication in Healthcare; 2011 Oct 17; Chicago, IL.

DRA: Other Conditions
DRE: Treatment - Observational, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Care Coordination, Care Management, Pain, Telemedicine
MeSH Terms: none