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.
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.
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.
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.
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.
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Treatment - Observational, Treatment - Efficacy/Effectiveness Clinical Trial
Care Management, Pain, Telemedicine