Impact of Mandated Case Review Policy on Opioid Discontinuation and Mortality Among High-Risk Long-Term Opioid Therapy Patients: The STORM Stepped-Wedge Cluster Randomized Controlled Trial.

BACKGROUND: Although long-term opioid therapy (LTOT) has its own risks, opioid discontinuation could pose harm for high-risk Veterans Health Administration (VHA) patients receiving LTOT. There is limited information on the impact of a mandate requiring providers to perform case reviews on high-risk patients with an active opioid prescription (ie, mandated case review policy) on opioid discontinuation and mortality. METHODS: Our study is a secondary data analysis of a 23-month stepped-wedge cluster randomized controlled trial between April 2018 and March 2020. The study included 10 685 LTOT patients with a predicted risk of a serious adverse event between the top 1% to 5% nationally who entered the risk range between 4/18/2018 and 11/9/2019. We examined whether the mandated case review policy had an impact on opioid discontinuation and mortality for the patients. RESULTS: Among 10 685 LTOT patients (88.2% male; mean [SD] age, 61.1 [11.7] years), 29.1% experienced discontinuation and the mortality rate was 9.5%. Patients under mandated case review had a decreased risk of opioid discontinuation (average marginal effect [AME], -11.16 [95% CI, -15.30 to -7.01] percentage points) and all-cause mortality (AME, -3.31 [95% CI, -5.63 to -1.00] percentage points), relative to patients who were not under the mandate. CONCLUSIONS: The VHA mandated case review policy was associated with lower probability of discontinuation and all-cause mortality for high-risk patients receiving LTOT. Interventions that maintain care engagement while optimizing pain management for high-risk patients may be beneficial for minimizing mortality and other risks associated with discontinuation.

Effect of a Veterans Health Administration mandate to case review patients with opioid prescriptions on mortality among patients with opioid use disorder: a secondary analysis of the STORM randomized control trial.

AIMS: The Veterans Health Administration (VHA) implemented the Stratification Tool for Opioid Risk Mitigation (STORM) to reduce the risk of serious adverse events (SAE) among patients with opioid analgesic prescriptions. VHA facilities were mandated to case review patients identified as high risk by STORM. The aim of this study was to measure the effect of this mandate on all-cause mortality and SAEs among VHA patients newly diagnosed with opioid use disorder (OUD). DESIGN: Secondary analysis of a stepped-wedged cluster randomized controlled trial conducted at all 140 VHA facilities, with facility as the unit of randomization, from 2018 to 2020. SETTING AND PARTICIPANTS: United States VHA facilities were randomized to case review the top 1 or 5% of high-risk patients prescribed opioid analgesics identified by STORM. A total of 28 251 patients were diagnosed with OUD during the trial and were considered control or treatment depending on the status of the facility where they received their OUD diagnosis. Post-hoc analyses among patients who had at least one opioid analgesic prescription in the 90 days prior to diagnosis were conducted and were then stratified by receipt of a prescription in the 90 days following diagnosis to assess the sensitivity of results to opioid discontinuation. MEASUREMENTS: All-cause mortality and opioid-related, drug-related, suicide-related and other SAEs within 90 days of OUD diagnosis. FINDINGS: Mandated case review increased the odds of 90-day mortality [odds ratio (OR) = 1.74, 95% confidence interval (CI) = 1.06, 2.87], but did not significantly change the odds of SAEs. Among patients who received an opioid prescription prior to but not after OUD diagnosis, the odds of all-cause mortality within 90 days was 5.87 (95% CI = 1.85, 18.58) relative to control patients. CONCLUSIONS: Veterans Health Administration patients newly diagnosed with opioid use disorder experienced increased all-cause mortality following expansion of a case review mandate for high-risk patients prescribed opioids.