IMPORTANCE Prescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines.OBJECTIVE To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk. DESIGN, SETTING, AND PARTICIPANTSCluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices.INTERVENTIONS Intervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only. MAIN OUTCOMES AND MEASURESPrimary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language.RESULTS Of the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P < .001; adjusted odds ratio [AOR], 6.0; 95% CI, 3.6-10.2), to have a patient-PCC agreement (of the 376 without an agreement at baseline, 53.8% vs 6.0%; P < .001; AOR, 11.9; 95% CI, 4.4-32.2), and to undergo at least 1 UDT (74.6% vs 57.9%; P < .001; AOR, 3.0; 95% CI, 1.8-5.0). There was no difference in odds of early refill receipt between groups (20.7% vs 20.1%; AOR, 1.1; 95% CI, 0.7-1.8). Intervention patients were more likely than controls to have either a 10% dose reduction or opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3-2.1; P < .001). In adjusted analyses, intervention patients had a mean (SE) MEDD 6.8 (1.6) mg lower than controls (P < .001). CONCLUSIONS AND RELEVANCEA multicomponent intervention improved guideline-concordant care but did not decrease early opioid refills.TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01909076

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Little is known about variability in primary care providers’ (PCPs) adherence to opioid-monitoring guidelines for patients. We examined variability of adherence to monitoring guidelines among PCPs and ascertained the relationship between PCP adherence and opioid misuse by their patients. We included primary care patients receiving long-term opioids (≥3 prescriptions within 6 months) for chronic noncancer pain and PCPs with ≥4 eligible patients. We examined guideline adherence using: (1) electronic health record documentation of opioid treatment agreement, (2) past-year urine drug screen (UDS), and (3) evidence of misuse through early refills (≥2 opioid prescriptions written 7–25 days after the previous prescription). Covariates included morphine equivalent daily opioid medication dose (MED, >50 mg/d vs ≤50mg/d). Multilevel regression models assessed variability among PCPs, and odds ratios examined associations among patient-level binary outcomes. Sixty-seven PCPs prescribed opioids to 1546 patients. Significant variability was found between PCPs in use of agreement (variance = 1.27, P<0.001), UDS (variance = 1.75, P <0.001), and early refills (variance = 0.29, P = 0.002). Primary care providers had a mean of 48% of patients with agreement (range, 9%–84%), 56% with ≥1 UDS (range, 7%–91%) and 36% with early refills (range, 19%–60%). High MED among patients was associated with increased odds of agreement (1.93, confidence interval [CI], 1.53–2.44), UDS (2.65, CI: 2.06–3.41), and early refill (2.92, CI: 2.30–3.70). Primary care providers varied significantly in adherence to opioid prescription guidelines. Increased patient risk was associated with increased monitoring and with greater misuse. Future work should study system-level interventions to enable clinical monitoring and support opioid guideline adherence.