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IIR 07-119 – HSR&D Study

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IIR 07-119
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 proposed 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 were to determine if: (a) Three Component Model (TCM) stepped care was superior to usual care in improving pain-related disability: (b) TCM stepped care was superior to usual care in improving secondary pain outcomes, including pain severity and global improvement of pain; and (c) TCM stepped care was superior to usual care in improving other outcomes, specifically depression, anxiety, health-related quality of life, and satisfaction with treatment.

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

Study subjects were randomized to the intervention arm or the usual care control arm. The intervention was based upon the empirically-validated Three-Component Model, which in SCOPE involved collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE involved a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention consisted 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 were treated with evidence-based guidelines for depression management. All medications provided to subjects were 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 received standard treatments from their primary care physician (PCP) that the PCP would usually provide for pain. Outcome assessments were conducted at baseline, 1, 3, 6, and 12 months by interviewers blinded to treatment arm for all study subjects.


FINDINGS/RESULTS:
Overall, mean (SD) baseline BPI scores in the intervention and control groups were 5.31 (1.81) and 5.12 (1.80), respectively. Compared with usual care, the intervention group had a 1.02-point lower (95% CI, 1.58 to 0.47) BPI score at 12 months (3.57 vs 4.59). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs 27.1%; relative risk, 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30% improvement. Secondary pain outcomes also improved. Few patients in either group required opioid initiation or dose escalation.

IMPACT:
Telecare collaborative management increased the proportion of primary care patients with improved chronic musculoskeletal pain. This was accomplished by optimizing nonopioid analgesic medications using a stepped care algorithm and monitoring.

PUBLICATIONS:

Journal Articles

  1. Guilkey RE, Draucker CB, Wu J, Yu Z, Kroenke K. Acceptability of a telecare intervention for persistent musculoskeletal pain. Journal of telemedicine and telecare. 2018 Jan 1; 24(1):44-50.
  2. Krebs EE, Kroenke K, Wu J, Bair MJ, Kozak MA, Yu Z. Opioid Use as a Predictor of Health Care Use and Pain Outcomes: Analysis of Clinical Trial Data. Pain medicine (Malden, Mass.). 2016 Jul 1; 17(7):1261-1268.
  3. Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosomatic medicine. 2016 Jul 1; 78(6):716-27.
  4. Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Medical care. 2016 Apr 1; 54(4):414-21.
  5. Scott EL, Kroenke K, Wu J, Yu Z. Beneficial Effects of Improvement in Depression, Pain Catastrophizing, and Anxiety on Pain Outcomes: A 12-Month Longitudinal Analysis. The journal of pain : official journal of the American Pain Society. 2016 Feb 1; 17(2):215-22.
  6. Koffel E, Kroenke K, Bair MJ, Leverty D, Polusny MA, Krebs EE. The bidirectional relationship between sleep complaints and pain: Analysis of data from a randomized trial. Health psychology : official journal of the Division of Health Psychology, American Psychological Association. 2016 Jan 1; 35(1):41-9.
  7. Outcalt SD, Kroenke K, Krebs EE, Chumbler NR, Wu J, Yu Z, Bair MJ. Chronic pain and comorbid mental health conditions: independent associations of posttraumatic stress disorder and depression with pain, disability, and quality of life. Journal of behavioral medicine. 2015 Jun 1; 38(3):535-43.
  8. Kroenke K, Yu Z, Wu J, Kean J, Monahan PO. Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain. Pain medicine (Malden, Mass.). 2014 Nov 1; 15(11):1892-901.
  9. Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16; 312(3):240-8.
  10. Chumbler NR, Kroenke K, Outcalt S, Bair MJ, Krebs E, Wu J, Yu Z. Association between sense of coherence and health-related quality of life among primary care patients with chronic musculoskeletal pain. Health and Quality of Life Outcomes. 2013 Dec 26; 11(1):216.
  11. Kroenke K, Outcalt S, Krebs E, Bair MJ, Wu J, Chumbler N, Yu Z. Association between anxiety, health-related quality of life and functional impairment in primary care patients with chronic pain. General hospital psychiatry. 2013 Jul 1; 35(4):359-65.
  12. 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. 2013 Mar 1; 34(2):270-81.
Conference Presentations

  1. Bair MJ. Building a Therapeutic Alliance with Patients with Chronic Pain. Paper presented at: Society of General Internal Medicine Annual Meeting; 2013 Apr 24; Denver, CO.
  2. 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.
  3. Matthias MS, Bergman AB, Bair MJ, Coffing JM, Collins LA, Krebs EE. "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 Management, Pain, Telemedicine
MeSH Terms: none

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