Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness

The United States is facing an opioid crisis in which overdose is the leading cause of injury death-misuse of opioids constitutes the vast majority of those deaths. In 2016 alone, over 42,000 people died from opioid overdose, an increase of 27% from the prior year. Deployment of the Stratification Tool for Opioid Risk Mitigation (STORM), a clinical decision support tool to improve opioid safety, is one response by the Veterans Health Administration (VHA) to the opioid crisis. STORM identifies VHA patients at very high risk of opioid-related adverse events and lists potential risk mitigation strategies. Deployment of STORM also helps VHA meet certain requirements of the Comprehensive Addiction and Recovery Act of 2016. In alignment with the VHA's learning health care system initiative, a multidisciplinary team designed a randomized evaluation of a policy approach to mandating case reviews of very-high-risk patients identified by STORM and the impacts of patient inclusion versus exclusion in mandated STORM case reviews using a stepped-wedge design. The STORM evaluation involves drafting the policy notice, shepherding it through the VHA approval process, and implementing the cluster randomized design. This mixed-methods evaluation includes (1) a qualitative assessment of medical center implementation strategies with the aim of understanding of how STORM is incorporated into practice, and (2) quantitative analyses of the relations between policy mandates and STORM inclusion on opioid-related adverse events. The findings from this synergistic research design will yield critical insights for VHA leadership to refine opioid prescribing-related policy and practice.