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

Abstract

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.

Keywords:

• Learning health care system
• opioids
• randomized program evaluation

Acknowledgments

The authors would like to thank Tom Dr. Rust for developing the framework for the policy notice. The authors would also like to thank the 2 anonymous reviewers for their valuable comments and suggestions to improve the quality of the manuscript.

Additional information

Funding

This work is supported by Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development (HSR&D SDR 16-196; QUERI PEC 16-001). Support for Dr. Walid and Dr. Hausmann are provided by HSR&D SDR 16-193. Dr. Garrido is supported by VA HSR&D CDA 11-201/CDP 12-255. Support for Dr. Lewis, Dr. Trafton, and Dr. Oliva are provided by the VA Office of Mental Health and Suicide Preventions. The funder had no role in the design of the study or preparation of the manuscript. This work represents the opinions of the authors alone and does not necessarily represent the views of the Department of Veterans Affairs, the United States Government, or any other institutions that authors are affiliated.

Notes on contributors

Taeko Minegishi

T.M. wrote the first draft of the manuscript. All authors contributed to the conception and design of the study and revised and approved the final version of the manuscript.