Browsing by Author "Noorbaloochi, Siamak"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial
    (Elsevier, 2017-11) Krebs, Erin E.; Jensen, Agnes C.; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J.; Kroenke, Kurt; Department of Medicine, School of Medicine
    This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12 months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31 months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21–80 years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care.
  • Thumbnail Image
    Item
    Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial
    (Oxford, 2019-09-14) Koffel, Erin; Kats, Allyson M.; Kroenke, Kurt; Bair, Matthew J.; Gravely, Amy; DeRonne, Beth; Donaldson, Melvin T.; Goldsmith, Elizabeth S.; Noorbaloochi, Siamak; Krebs, Erin E.; Medicine, School of Medicine
    Objective Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy. Design Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120). Methods We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups. Results The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164). Conclusions Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.