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Although opioids are appropriate in some circumstances, opioid prescribing carries substantial risk of overdose, death, and other adverse outcomes. Recognizing the danger opioids pose to patients, Congress passed and President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA) last summer. One of the Act's requirements is that the risk of adverse events be assessed with an automated tool before prescribing opioids to a Veteran who receives VA healthcare.
The Office of Mental Health Operations (OMHO) has already developed a tool that can provide VA clinicians with patients' predicted risk of adverse events. The Stratification Tool for Opioid Risk Management (STORM) feeds real-time, clinical-decision support tools for patient risk identification and targeted intervention, including for patients considering or receiving opioid medications - or those with opioid use disorders. STORM also displays and tracks the use of recommended risk-mitigation strategies, including provision of naloxone kits, low opioid dosage, and use of non-opioid pain management approaches such as physical therapy and acupuncture, among others. Finally, data pertaining to STORM use are automatically collected to facilitate updated tracking on a nightly basis.
STORM has already been pilot tested for validation and usability. However, VA will soon go one important step further in assessing STORM. With funding from QUERI and HSR&D, STORM and a new policy requiring its use will be assessed in a randomized program evaluation. Once approved, the policy will require all VA healthcare facilities to use STORM to review the cases of patients at high risk of adverse outcomes from opioid prescriptions. If they do not meet a targeted proportion of cases reviewed, half of the facilities - randomly selected - will be subject to consequences stipulated in the version of the policy memo they receive (submission of action plans and closer oversight by OMHO). As the trial progresses, the range of the risk strata facilities must review will be increased in a randomized, stepped-wedge design. The randomization across arms (consequences vs. no consequences) and stepped-wedge randomization of risk strata permit rigorous evaluation of STORM, as well as the policy that requires its use.
The evaluation is coordinated by the Partnered Evidence-based Resource Center (PEPReC) at the VA Boston Healthcare System, which also will evaluate STORM and the policy using routinely collected administrative data. PEPReC is joined in this collaborative effort by OMHO and researchers at the Center for Health Equity Research and Promotion (CHERP), VA Pittsburgh Healthcare System. The CHERP team will field surveys and conduct interviews to assess implementation facilitators and barriers. Evaluation outcomes include overdose, suicide-related events, accidents, implementation strategies, and case review completion rates.
With STORM, VA is well positioned to respond to the requirements of CARA. With the planned evaluation coordinated by PEPReC, VA is going above and beyond CARA requirements, exhibiting its commitment to the principles of a learning health care system.
For more information, contact Austin Frakt, PhD, Associate Director of PEPReC, at Austin.Frakt@va.gov .