Protocol for evaluating the nationwide implementation of the VA Stratification Tool for Opioid Risk Management (STORM)

摘要

BackgroundDrug overdoses have become the number one cause of accidental deaths in the United States (US). In particular, opioid overdose rates have surpassed the highest death rates from HIV, firearms, and motor vehicle accidents [1, 2]. Many have called the increase in opioid use and opioid-related adverse events a public health epidemic [3,4,5,6,7]. The increase in opioid medication prescribing has been a significant contributor to the increase in the incidence of drug overdose [8,9,10,11,12]. In 2014, 4.3 million people abused the prescription of opioids and 1.9 million people had an opioid use disorder (OUD) related to prescription opioids [13]. A seminal study in the Veterans Affairs (VA) Healthcare System demonstrated an association between receiving higher opioid doses and increased risk of opioid overdose death [9]. A similar risk has been demonstrated in non-VA settings [11, 12].Opioid abuse is especially problematic among VA patients, as the annual prevalence rates are almost seven times higher than found in commercial health plans [14]. The number of Veterans receiving opioids at the VA almost doubled from 651,000 Veterans in 2001 to 1,101,346 in 2013. In 2013, 23% of VA pharmacy users received an opioid, up from 19% in 2001. Although opioid prescriptions have declined from 2013 to 2017 [15], safe prescribing remains a significant problem.In 2013, VA launched the Opioid Safety Initiative to promote the safe and effective use of opioid analgesics. A major component of this initiative was the calculation and dissemination of monthly metrics on the average dose per day of select opioids and number of patients on concomitant opioids and benzodiazepines to facility and regional leaders (regions defined by 18 independent Veterans Integrated Service Networks (VISNs)) [16].To augment these monthly metrics, the Office of Mental Health and Suicide Prevention (OMHSP) and the National Pain Management Program developed a predictive model to estimate the risk of serious adverse events (or SAEs, i.e., suicide-related events, overdoses, overdose deaths) among patients who are prescribed opioids. OMHSP translated the predictive model into the Stratification Tool for Opioid Risk Management (STORM). OMHSP developed STORM to empower facilities and clinicians to provide targeted opioid risk mitigation strategies to the most at-risk Veterans [17]. Using data from electronic medical records on demographics, previous overdose or suicide-related events, prescriptions, substance use and mental health disorders, and medical co-morbidities, the STORM algorithm calculates a “risk score” of SAEs for each Veteran who is prescribed opioids [17]. Updated nightly and based on the underlying predictive model, the STORM dashboard displays the estimated % chance of experiencing an SAE for each Veteran as well as their level risk categorized as low, medium, high or very high (for filtering purposes). The STORM dashboard also displays various risk factors that apply to each patient, including relevant diagnoses, prescriptions (opioid, pain, sedation), and use of risk mitigation strategies (including non-pharmacologic treatments). Finally, to support care coordination, the STORM dashboard also displays upcoming appointments to primary care, mental health, pain clinic, or other treatment sources.In March of 2018, the VA released a national policy notice requiring all VA Medical Centers (VAMCs) to conduct data-based case reviews of patients with opioid prescriptions that STORM identifies as having very high risk of SAEs. Case reviews entail using the STORM dashboard and/or other data-based procedures (e.g., consulting state Prescription Drug Monitoring Programs) to evaluate each patient’s risk level and determine whether additional risk mitigation strategies (e.g., referral to pain specialist, prescription of naloxone kit) are indicated for that patient. The completed case review and any actions taken by the clinician are documented using a standardized note in the VA electronic medical record and in the STORM dashboard.The dissemination of the policy notice and the impact of deploying STORM were selected as the focus of a randomized program evaluation for several reasons. First, the policy was motivated by the Commission on Care [18], a synthesis of an independent assessment of VA care, which recommended that VA, “Adopt a continuous improvement methodology to support VA transformation, and consolidate best practices...”. Also, the STORM dashboard is aligned with VA priorities to improve opioid safety, has the potential to fulfill the VA’s obligation to provide targeted opioid risk mitigation under the 2016 Comprehensive Addiction and Recovery Act (CARA; Public Law 114-198), and is ready for widespread implementation.The STORM randomized program evaluation is being conducted by the VA Center for Health Equity Research and Promotion (CHERP), the Partnered Evidence-Based Policy Resource Center (PEPReC), and OMHSP. As described elsewhere a