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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. [ABSTRACT FROM AUTHOR]

Importance: Patients prescribed long-term opioid therapy for chronic pain often experience unrelieved pain, poor quality of life, and serious adverse events., Objective: To compare the effects of integrated pain team (IPT) vs pharmacist collaborative management (PCM) on pain and opioid dosage., Design, Setting, and Participants: This study was a pragmatic multisite 12-month randomized comparative effectiveness trial with masked outcome assessment. Patients were recruited from October 2017 to March 2021; follow-up was completed June 2022. The study sites were Veterans Affairs primary care clinics. Eligible patients had moderate to severe chronic pain despite long-term opioid therapy (≥20 mg/d for at least 3 months)., Interventions: IPT involved interdisciplinary pain care planning, visits throughout 12 months with medical and mental health clinicians, and emphasis on nondrug therapies and motivational interviewing. PCM was a collaborative care intervention involving visits throughout 12 months with a clinical pharmacist care manager who conducted structured monitoring and medication optimization. Both interventions provided individualized pain care and opioid tapering recommendations to patients., Main Outcomes and Measures: The primary outcome was pain response (≥30% decrease in Brief Pain Inventory total score) at 12 months. The main secondary outcome was 50% or greater reduction in opioid daily dosage at 12 months., Results: A total of 820 patients were randomized to IPT (n = 411) or PCM (n = 409). Participants' mean (SD) age was 62.2 (10.6) years, and 709 (86.5%) were male. A pain response was achieved in 58/350 patients in the IPT group (16.4%) vs 54/362 patients in the PCM group (14.9%) (odds ratio, 1.11 [95% CI, 0.74-1.67]; P = .61). A 50% opioid dose reduction was achieved in 102/403 patients in the IPT group (25.3%) vs 98/399 patients in the PCM group (24.6%) (odds ratio, 1.03 [95% CI, 0.75-1.42]; P = .85). Over 12 months, the mean (SD) Brief Pain Inventory total score improved from 6.7 (1.5) points to 6.1 (1.8) points (P < .001) in IPT and from 6.6 (1.6) points to 6.0 (1.9) points (P < .001) in PCM (between-group P = .82). Over 12 months, mean (SD) opioid daily dosage decreased from 80.8 (74.2) mg/d to 54.2 (65.0) mg/d in IPT (P < .001) and from 74.5 (56.9) mg/d to 52.8 (51.9) mg/d (P < .001) in PCM (between-group P = .22)., Conclusions and Relevance: Outcomes in this randomized clinical trial did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage., Trial Registration: ClinicalTrials.gov Identifier: NCT03026790.