Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics ☆ , ☆☆ Kurt Kroenke a, b, c, ⁎, Erin Krebs d, e , Jingwei Wu f , Matthew J. Bair a, b, c , Teresa Damush a, b, c, g , Neale Chumbler a, h , Tish York a , Sharon Weitlauf a , Stephanie McCalley a , Erica Evans a , Jeffrey Barnd a , Zhangsheng Yu f a VA HSR&D Center for Implementing Evidence-Based Practice, Roudebush VA Medical Center, Indianapolis, IN, United States b Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States c Regenstrief Institute, Inc., Indianapolis, IN, United States d VA HSR&D Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care, System, Minneapolis, MN, United States e University of Minnesota Medical School, Minneapolis, MN, United States f Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, United States g VA Stroke QUERI Center and Indiana University Center for Aging, Indianapolis, IN, United States h Department of Health Policy and Management, College of Public Health, University of Georgia, Athens, GA, United States article info abstract Article history: Received 27 August 2012 Revised 16 November 2012 Accepted 18 November 2012 Available online 8 December 2012 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. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. Published by Elsevier Inc. Keywords: Pain Therapy Analgesics Clinical trial Primary care Telehealth Contemporary Clinical Trials 34 (2013) 270–281 ☆ Trial Registration clinicaltrials.gov Identifier: NCT00926588. ☆☆ Funding: This work was supported by a Department of Veterans Affairs Health Services Research and Development Merit Review award to Dr. Kroenke (IIR 07–119) and Career Development Award to Dr. Krebs (CDA2 07–215). The sponsor had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. ⁎ Corresponding author at: Regenstrief Institute, 5th Floor, 1050 Wishard Blvd, Indianapolis, IN 46202, United States. Tel.: +1 317 630 7447; fax: +1 317 630 8776. E-mail address: kkroenke@regenstrief.org (K. Kroenke). 1551-7144/$ – see front matter. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.cct.2012.11.008 Contents lists available at SciVerse ScienceDirect Contemporary Clinical Trials journal homepage: www.elsevier.com/locate/conclintrial