Care Models to Improve Pain and Reduce Opioids among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial

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.