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.

A call for better validation of opioid overdose risk algorithms.

Clinical decision support (CDS) systems powered by predictive models have the potential to improve the accuracy and efficiency of clinical decision-making. However, without sufficient validation, these systems have the potential to mislead clinicians and harm patients. This is especially true for CDS systems used by opioid prescribers and dispensers, where a flawed prediction can directly harm patients. To prevent these harms, regulators and researchers have proposed guidance for validating predictive models and CDS systems. However, this guidance is not universally followed and is not required by law. We call on CDS developers, deployers, and users to hold these systems to higher standards of clinical and technical validation. We provide a case study on two CDS systems deployed on a national scale in the United States for predicting a patient's risk of adverse opioid-related events: the Stratification Tool for Opioid Risk Mitigation (STORM), used by the Veterans Health Administration, and NarxCare, a commercial system.

Healthcare costs and use before and after opioid overdose in Veterans Health Administration patients with opioid use disorder.

AIMS: To compare healthcare costs and use between United States (US) Veterans Health Administration (VHA) patients with opioid use disorder (OUD) who experienced an opioid overdose (OD cohort) and patients with OUD who did not experience an opioid overdose (non-OD cohort). DESIGN: This is a retrospective cohort study of administrative and clinical data. SETTING: The largest integrated national health-care system is the US Veterans Health Administration's healthcare systems. PARTICIPANTS: We included VHA patients diagnosed with OUD from October 1, 2017 through September 30, 2018. We identified the index date of overdose for patients who had an overdose. Our control group, which included patients with OUD who did not have an overdose, was randomly assigned an index date. A total of 66 513 patients with OUD were included for analysis (OD cohort: n = 1413; non-OD cohort: n = 65 100). MEASUREMENTS: Monthly adjusted healthcare-related costs and use in the year before and after the index date. We used generalized estimating equation models to compare patients with an opioid overdose and controls in a difference-in-differences framework. FINDINGS: Compared with the non-OD cohort, an opioid overdose was associated with an increase of $16 890 [95% confidence interval (CI) = $15 611-18 169; P < 0.001] in healthcare costs for an estimated $23.9 million in direct costs to VHA (95% CI = $22.1 million, $25.7 million) within the 30 days following overdose after adjusting for baseline characteristics. Inpatient costs ($13 515; 95% CI = $12 378-14 652; P < 0.001) reflected most of this increase. Inpatient days (+6.15 days; 95% CI, = 5.33-6.97; P < 0.001), inpatient admissions (+1.01 admissions; 95% CI = 0.93-1.10; P < 0.001) and outpatient visits (+1.59 visits; 95% CI = 1.34-1.84; P < 0.001) also increased in the month after opioid overdose. Within the overdose cohort, healthcare costs and use remained higher in the year after overdose compared with pre-overdose trends. CONCLUSIONS: The US Veterans Health Administration patients with opioid use disorder (OUD) who have experienced an opioid overdose have increased healthcare costs and use that remain significantly higher in the month and continuing through the year after overdose than OUD patients who have not experienced an overdose.

Effect of a Predictive Analytics-Targeted Program in Patients on Opioids: a Stepped-Wedge Cluster Randomized Controlled Trial.

BACKGROUND: Risk of overdose, suicide, and other adverse outcomes are elevated among sub-populations prescribed opioid analgesics. To address this, the Veterans Health Administration (VHA) developed the Stratification Tool for Opioid Risk Mitigation (STORM)-a provider-facing dashboard that utilizes predictive analytics to stratify patients prescribed opioids based on risk for overdose/suicide. OBJECTIVE: To evaluate the impact of the case review mandate on serious adverse events (SAEs) and all-cause mortality among high-risk Veterans. DESIGN: A 23-month stepped-wedge cluster randomized controlled trial in all 140 VHA medical centers between 2018 and 2020. PARTICIPANTS: A total of 44,042 patients actively prescribed opioid analgesics with high STORM risk scores (i.e., percentiles 1% to 5%) for an overdose or suicide-related event. INTERVENTION: A mandate requiring providers to perform case reviews on opioid analgesic-prescribed patients at high risk of overdose/suicide. MAIN MEASURES: Nine serious adverse events (SAEs), case review completion, number of risk mitigation strategies, and all-cause mortality. KEY RESULTS: Mandated review inclusion was associated with a significant decrease in all-cause mortality within 4 months of inclusion (OR: 0.78; 95% CI: 0.65-0.94). There was no detectable effect on SAEs. Stepped-wedge analyses found that mandated review patients were five times more likely to receive a case review than non-mandated patients with similar risk (OR: 5.1; 95% CI: 3.64-7.23) and received more risk mitigation strategies than non-mandated patients (0.498; CI: 0.39-0.61). CONCLUSIONS: Among VHA patients prescribed opioid analgesics, identifying high risk patients and mandating they receive an interdisciplinary case review was associated with a decrease in all-cause mortality. Results suggest that providers can leverage predictive analytic-targeted population health approaches and interdisciplinary collaboration to improve patient outcomes. TRIAL REGISTRATION: ISRCTN16012111.

Medication Use Evaluation of High-Dose Long-Term Opioid De-prescribing in Multiple Veterans Affairs Medical Centers.

BACKGROUND: The Opioid Safety Initiative (OSI) was implemented in 2013 to enhance the safe and appropriate use of opioids in the Veterans Health Administration (VA). Opioid use decreased nationally in subsequent years, but characterization of opioid de-prescribing practices has not been well established. OBJECTIVES: To describe changes in patient characteristics and patterns of de-prescribing since OSI implementation for opioid users at > 90 morphine equivalent daily dose for at least 90 days for those that discontinued opioids within the VA. DESIGN: Retrospective observational pre-post intervention medication use evaluation using VA data and electronic health records to identify differences in opioid de-prescribing between fiscal year 2013 (FY13; early OSI) and FY17 (late OSI). Reviewers' insights for local opioid management and de-prescribing practices collected through web-based post-data collection survey. PARTICIPANTS: Veterans prescribed high-dose long-term opioid therapy in FY13 and FY17 who subsequently discontinued opioids at 27 VA medical centers. MAIN MEASURES: Chart review data from local facility reviewers identified socioeconomic characteristics, opioid de-prescribing rationale (e.g., risk-benefit, diversion) and practices (e.g., rate of opioid discontinuation, taper monitoring activities, withdrawal monitoring), and outcomes following discontinuation. KEY RESULTS: Among 315 patients in FY13 and 322 patients in FY17 with opioid discontinuation, discontinuation rationale focused on diversion in FY13 and risk-benefit in FY17. Clinical pharmacists and pain management specialists had increased involvement in FY17 opioid discontinuations (36% versus 16%). Of all discontinuations, 56% of patients were tapered in FY13 versus 70% of patients in FY17. Tapering plans were longer in FY17 than in FY13 (163 days versus 65 days). Transitions to non-opioid pain therapy following opioid discontinuation were higher in FY17 compared to FY13 (70% versus 60%). CONCLUSIONS: Veterans discontinued from high-dose long-term opioids in FY17 were more optimally managed compared to those in FY13. Findings suggest improvements in opioid de-prescribing following OSI implementation, but interpretation is limited by study design.

Association of multidisciplinary education and research in substance use and addiction's (AMERSA) 2021 transforming care through evidence and policy conference: Tackling stigma and giving voice to lived experience.

This commentary provides an overview of the Association of Multidisciplinary Education and Research in Substance use and Addiction (AMERSA) 2021 annual conference: Transforming Care Through Evidence and Policy. The topics covered during the conference were especially critical given the unprecedented rise in drug overdose deaths and continued impact of the COVID-19 pandemic on substance use and addiction. The importance of tackling stigma and ensuring that we partner with those with lived experience to have maximal impact was highlighted.

Randomized Policy Evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM).

BACKGROUND: The Veterans Health Administration (VHA) developed a dashboard Stratification Tool for Opioid Risk Mitigation (STROM) to guide clinical practice interventions. VHA released a policy mandating that high-risk patients of an adverse event based on the STORM dashboard are to be reviewed by an interdisciplinary team of clinicians. AIM: Randomized program evaluation to evaluate if patients in the oversight arm had a lower risk of opioid-related serious adverse events (SAEs) or death compared to those in the non-oversight arm. SETTING AND PARTICIPANTS: One-hundred and forty VHA facilities (aka medical centers) were randomly assigned to two groups: oversight and non-oversight arms. VHA patients who were prescribed opioids between April 18, 2018, and November 8, 2019, were included in the cohort. PROGRAM DESCRIPTION: We hypothesized that patients cared for by VHA facilities that received the policy with the oversight accountability language would achieve lower opioid-related SAEs or death. PROGRAM EVALUATION: We did not observe a relationship between the oversight arm and opioid-related SAEs or death. Patients in the non-oversight arm had a significantly higher chance of receiving a case review compared to those in the oversight arm. DISCUSSION: Even though our findings were unexpected, the STORM policy overall was likely successful in focusing the provider's attention on very high-risk patients.

Alcohol use disorder pharmacotherapy and treatment in primary care (ADaPT-PC) trial: Impact on identified barriers to implementation.

Background: A minority of individuals meeting diagnostic criteria for alcohol use disorders (AUD) receive any type of formal treatment. Developing options for AUD treatment within primary care settings is imperative to increase treatment access. A multi-faceted implementation intervention including provider and patient education, clinician reminders, development of local champions and ongoing facilitation was designed to enhance access to AUD pharmacotherapy in primary care settings at three large Veterans Health Administration (VHA) facilities. This qualitative study compared pre-implementation barriers to post-implementation barriers identified via provider interviews to identify those barriers addressed and not addressed by the intervention to better understand the limited impact of the intervention. Methods: Following the nine-month implementation period, primary care providers at the three participating facilities took part in qualitative interviews to collect perceptions regarding which pre-implementation barriers had and had not been successfully addressed by the intervention. Participants included 20 primary care providers from three large VHA facilities. Interviews were coded using common coding techniques for qualitative data using the Consolidated Framework for Implementation Research (CFIR) codebook. Summary reports were created for each CFIR construct for each facility and the impact of each CFIR construct on implementation was coded as positive, neutral, or negative. Results: Some barriers identified during pre-implementation interviews were no longer identified as barriers in the post-implementation interviews. These included Relative Advantage, Relative Priority, and Knowledge & Beliefs about the Innovation. However, Compatibility, Design Quality & Packaging, and Available Resources remained barriers at the end of the implementation period. No substantial new barriers were identified. Conclusions: The implementation intervention appears to have been successful at addressing barriers that could be mitigated with traditional educational approaches. However, the intervention did not adequately address structural and organizational barriers to implementation. Recommendations for enhancing future interventions are provided.

Naloxone Dispensing in Patients at Risk for Opioid Overdose After Total Knee Arthroplasty Within the Veterans Health Administration.

Background: Naloxone prescribing among patients undergoing surgery is not well described. This cohort study was designed to examine patients' risk factors for opioid overdose and their association with naloxone prescribing among veterans undergoing total knee arthroplasty (TKA) after a systemwide Overdose Education and Naloxone Distribution (OEND) initiative. Methods: A retrospective analysis of Veterans Health Administration (VHA) records was performed and consisted of 38,011 veterans undergoing primary TKA from 2013 to 2016. Patient overdose risk was determined using a validated risk index for overdose or serious opioid-induced respiratory depression (RIOSORD) based on patient diagnoses, health care utilization, and prescription drug use. Naloxone dispensing was examined from the year before surgery until 7 days after discharge. These rates were examined the year prior to implementation of a national OEND initiative (2013), the year of implementation (2014), and 2 years following implementation (2015-2016). Results: In 2013, 3.3% of patients presenting for TKA had moderate or high risk for overdose and none were prescribed naloxone. By 2016, after OEND implementation, 2.2% of patients presenting for TKA had moderate or high risk for overdose, but only 10.9% of the moderate-risk and 12.7% of the high-risk patients were prescribed naloxone. Conclusions: Patients presenting for TKA routinely have risk factors for opioid overdose and significant proportions are at moderate or high risk for overdose. Despite this, most patients at moderate and high risk do not receive perioperative naloxone. Risk mitigation strategies using validated tools such as RIOSORD may help identify surgical patients at greatest risk for opioid overdose who could benefit from OEND.

Development and field testing of primary care screening tools for harms of long-term opioid therapy continuation and tapering to discontinuation: a study protocol.

INTRODUCTION: Despite calls for screening tools to help providers monitor long-term opioid therapy (LTOT) harms, and identify patients likely to experience harms of discontinuation, such screening tools do not yet exist. Current assessment tools are infeasible to use routinely in primary care and focus mainly on behaviours suggestive of opioid use disorder to the exclusion of other potential harms. This paper describes a study protocol to develop two screening tools that comprise one integrated instrument, Screen to Evaluate and Treat (SET). SET1 will indicate if LTOT may be harmful to continue (yes or no), and SET2 will indicate if tapering to discontinue opioids may be harmful to initiate (yes or no). Patients receiving LTOT who screen positive on the SET tools should receive subsequent additional assessment. SET will give providers methods that are feasible to implement routinely to facilitate more intensive and comprehensive monitoring of patients on LTOT and decision-making about discontinuation. METHODS AND ANALYSIS: We will develop the screening tools, SET1 and SET2, concurrently. Tool development will be done in stages: (1) comprehensive literature searches to yield an initial item pool for domains covered by each screening tool; (2) qualitative item analyses using interviews, expert review and cognitive interviewing, with subsequent item revision, to yield draft versions of each tool; and (3) field testing of the draft screening tools to assess internal consistency, test-retest reliability and convergent and discriminant validity. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Boards of Stanford University and the University of California, San Francisco for the VA Palo Alto Health Care System, and the VA San Francisco Healthcare System, respectively. Findings will be disseminated through peer-reviewed manuscripts and presentations at research conferences.

Opioid Use and Its Relationship to Cardiovascular Disease and Brain Health: A Presidential Advisory From the American Heart Association.

The misuse of opioids continues to be epidemic, resulting in dependency and a recent upsurge in drug overdoses that have contributed to a significant decrease in life expectancy in the United States. Moreover, recent data suggest that commonly used opioids for the management of pain may produce undesirable pharmacological actions and interfere with critical medications commonly used in cardiovascular disease and stroke; however, the impact on outcomes remains controversial. The American Heart Association developed an advisory statement for health care professionals and researchers in the setting of cardiovascular and brain health to synthesize the current literature, to provide approaches for identifying patients with opioid use disorder, and to address pain management and overdose. A literature and internet search spanning from January 1, 2012, to February 15, 2021, and limited to epidemiology studies, reviews, consensus statements, and guidelines in human subjects was conducted. Suggestions and considerations listed in this document are based primarily on published evidence from this review whenever possible, as well as expert opinion. Several federal and institutional consensus documents and clinical resources are currently available to both patients and clinicians; however, none have specifically addressed cardiovascular disease and brain health. Although strategic tools and therapeutic approaches for recognition of opioid use disorder and safe opioid use are available for health care professionals who manage patients with cardiovascular disease and stroke, high-quality evidence does not currently exist. Therefore, there is an urgent need for more research to identify the most effective approaches to improve care for these patients.

Saving Lives: The Veterans Health Administration (VHA) Rapid Naloxone Initiative.

BACKGROUND: The United States is in the midst of an opioid epidemic within the COVID-19 pandemic, and veterans are twice as likely to die from accidental overdose compared to non-veterans. This article describes the Veterans Health Administration (VHA) Rapid Naloxone Initiative, which aims to prevent opioid overdose deaths among veterans through (1) opioid overdose education and naloxone distribution (OEND) to VHA patients at risk for opioid overdose, (2) VA Police naloxone, and (3) select automated external defibrillator (AED) cabinet naloxone. METHODS: VHA has taken a multifaceted, theory-based approach to ensuring the rapid availability of naloxone to prevent opioid overdose deaths. Strategies targeted at multiple levels (for example, patient, provider, health care system) have enabled synergies to speed diffusion of this lifesaving practice. RESULTS: As of April 2021, 285,279 VHA patients had received naloxone from 31,730 unique prescribers, with 1,880 reported opioid overdose reversals with naloxone; 129 VHA facilities had equipped 3,552 VA Police officers with naloxone, with 136 reported opioid overdose reversals with VA Police naloxone; and 77 VHA facilities had equipped 1,095 AED cabinets with naloxone, with 10 reported opioid overdose reversals with AED cabinet naloxone. Remarkably, the COVID-19 pandemic had minimal impact on naloxone dispensing to VHA patients. CONCLUSION: The VHA Rapid Naloxone Initiative saves lives. VHA is sharing many of the tools and resources it has developed to support uptake across other health care systems. Health care systems need to work together to combat this horrific epidemic within a pandemic and prevent a leading cause of accidental death (opioid overdose).

Cost-effectiveness of Treatments for Opioid Use Disorder.

Importance: Opioid use disorder (OUD) is a significant cause of morbidity and mortality in the US, yet many individuals with OUD do not receive treatment. Objective: To assess the cost-effectiveness of OUD treatments and association of these treatments with outcomes in the US. Design and Setting: This model-based cost-effectiveness analysis included a US population with OUD. Interventions: Medication-assisted treatment (MAT) with buprenorphine, methadone, or injectable extended-release naltrexone; psychotherapy (beyond standard counseling); overdose education and naloxone distribution (OEND); and contingency management (CM). Main Outcomes and Measures: Fatal and nonfatal overdoses and deaths throughout 5 years, discounted lifetime quality-adjusted life-years (QALYs), and costs. Results: In the base case, in the absence of treatment, 42 717 overdoses (4132 fatal, 38 585 nonfatal) and 12 660 deaths were estimated to occur in a cohort of 100 000 patients over 5 years, and 11.58 discounted lifetime QALYs were estimated to be experienced per person. An estimated reduction in overdoses was associated with MAT with methadone (10.7%), MAT with buprenorphine or naltrexone (22.0%), and when combined with CM and psychotherapy (range, 21.0%-31.4%). Estimated deceased deaths were associated with MAT with methadone (6%), MAT with buprenorphine or naltrexone (13.9%), and when combined with CM, OEND, and psychotherapy (16.9%). MAT yielded discounted gains of 1.02 to 1.07 QALYs per person. Including only health care sector costs, methadone cost $16 000/QALY gained compared with no treatment, followed by methadone with OEND ($22 000/QALY gained), then by buprenorphine with OEND and CM ($42 000/QALY gained), and then by buprenorphine with OEND, CM, and psychotherapy ($250 000/QALY gained). MAT with naltrexone was dominated by other treatment alternatives. When criminal justice costs were included, all forms of MAT (with buprenorphine, methadone, and naltrexone) were associated with cost savings compared with no treatment, yielding savings of $25 000 to $105 000 in lifetime costs per person. The largest cost savings were associated with methadone plus CM. Results were qualitatively unchanged over a wide range of sensitivity analyses. An analysis using demographic and cost data for Veterans Health Administration patients yielded similar findings. Conclusions and Relevance: In this cost-effectiveness analysis, expanded access to MAT, combined with OEND and CM, was associated with cost-saving reductions in morbidity and mortality from OUD. Lack of widespread MAT availability limits access to a cost-saving medical intervention that reduces morbidity and mortality from OUD. Opioid overdoses in the US likely reached a record high in 2020 because of COVID-19 increasing substance use, exacerbating stress and social isolation, and interfering with opioid treatment. It is essential to understand the cost-effectiveness of alternative forms of MAT to treat OUD.

Opioid Prescribing and Opioid Risk Mitigation Strategies in the Veterans Health Administration.

INTRODUCTION: The Veterans Health Administration (VHA) has taken a multifaceted approach to addressing opioid safety and promoting system-wide opioid stewardship. AIM: To provide a comprehensive evaluation of current opioid prescribing practices and implementation of risk mitigation strategies in VHA. SETTING: VHA is the largest integrated health care system in the United States. PROGRAM DESCRIPTION: VHA prescribing data in conjunction with implementation of opioid risk mitigation strategies are routinely tracked and reviewed by VHA's Pharmacy Benefits Management Services (including Academic Detailing Service) and the Pain Management Program Office. Additional data are derived from the Partnered Evidence-Based Policy Resource Center (PEPReC) and from a 2019 survey of interdisciplinary pain management teams at VHA facilities. Prescribing data are reported quarterly until first quarter fiscal year 2020 (Q1FY2020), ending December 31, 2019. PROGRAM EVALUATION: VHA opioid dispensing peaked in 2012 with 679,376 Veterans receiving an opioid prescription, and when including tramadol, in 2013 with 869,956 Veterans. Since 2012, the number of Veterans dispensed an opioid decreased 56% and co-prescribed opioid/benzodiazepine decreased 83%. Veterans with high-dose opioids (≥ 100 mg morphine equivalent daily dose) decreased 77%. In Q1FY2020, among Veterans on long-term opioid therapy (LTOT), 91.1% had written informed consent, 90.8% had a urine drug screen, and 89.0% had a prescription drug monitoring program query. Naloxone was issued to 217,469 Veterans and resulted in > 1,000 documented overdose reversals. In 2019, interdisciplinary pain management teams were fully designated at 68%, partially designated at 28%, and not available at 4% of 140 VA parent facilities. Fifty percent of Veterans on opioids at very high risk for overdose/suicide received interdisciplinary team reviews. IMPLICATIONS: VHA clinicians have greatly reduced their volume of opioid prescribing for pain management and expanded implementation of opioid risk mitigation strategies. IMPACTS: VHA's integrated health care system provides a model for opioid stewardship and interdisciplinary pain care.

Opioid Discontinuation Among Patients Receiving High-Dose Long-Term Opioid Therapy in the Veterans Health Administration.

BACKGROUND: Prior opioid discontinuation studies have focused on one of two characteristics of opioid prescribing, its duration (long term vs not) or dosage (high vs low). Questions remain about the experience of patients with high-dose, long-term opioid therapy (HLOT) prescriptions who are likely to be at the highest risk for adverse events. OBJECTIVE: We address the following questions among the Veterans Health Administration (VHA) patients receiving HLOT: 1), How has the prevalence of discontinuation of opioids changed over time? 2), How do patient characteristics vary between those who do and do not discontinue? And 3), how does the prevalence of discontinuation vary geographically? DESIGN: A retrospective observational study of VHA patients with HLOT between fiscal year (FY) 2014 and FY2018. PARTICIPANTS: We identified 1,281,330 patients from VHA outpatient opioid prescription data with at least a 1-day opioid supply between FY2014 and FY2018. We identified and excluded those receiving palliative care or diagnosed with metastatic cancer. MAIN MEASURES: For a given patient and month, a patient having a 3-month moving average of ≥ 90 daily morphine milligram equivalent (MME) was defined as having HLOT. Similarly, we used a three-month average MME of zero as discontinuation. KEY RESULTS: The prevalence of discontinuation among patients with HLOT increased from 6.3% in FY2014 to 7.8% in FY2018. Across the years, patients who discontinued were younger, less likely to be married, and more likely to have comorbidities related to substance use disorders compared with patients who continued to receive HLOT. Incidence of discontinuation among those with HLOT increased in more than half (64%) of the 129 VHA medical centers. CONCLUSION: Prevalence of patients receiving HLOT in the VHA decreased as the incidence of discontinuation increased. Further research is needed to understand the process by which patients are discontinued and to assess the relationship between discontinuation and health outcomes.

Tracking implementation strategies in the randomized rollout of a Veterans Affairs national opioid risk management initiative.

BACKGROUND: In 2018, the Department of Veterans Affairs (VA) issued Notice 2018-08 requiring facilities to complete "case reviews" for Veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as high risk for adverse outcomes among patients prescribed opioids. Half of the facilities were randomly assigned to a Notice version including additional oversight. We evaluated implementation strategies used, whether strategies differed by randomization arm, and which strategies were associated with case review completion rates. METHODS: Facility points of contact completed a survey assessing their facility's use of 68 implementation strategies based on the Expert Recommendations for Implementing Change taxonomy. We collected respondent demographic information, facility-level characteristics, and case review completion rates (percentage of high-risk patients who received a case review). We used Kruskal-Wallis tests and negative binomial regression to assess strategy use and factors associated with case reviews. RESULTS: Contacts at 89 of 140 facilities completed the survey (64%) and reported using a median of 23 (IQR 16-31) strategies. The median case review completion rate was 71% (IQR 48-95%). Neither the number or types of strategies nor completion rates differed by randomization arm. The most common strategies were using the STORM dashboard (97%), working with local opinion leaders (80%), and recruiting local partners (80%). Characteristics associated with case review completion rates included respondents being ≤ 35 years old (incidence rate ratio, IRR 1.35, 95% CI 1.09-1.67) and having < 5 years in their primary role (IRR 1.23; 95% CI 1.01-1.51), and facilities having more prior academic detailing around pain and opioid safety (IRR 1.40, 95% CI 1.12-1.75). Controlling for these characteristics, implementation strategies associated with higher completion rates included (1) monitoring and adjusting practices (adjusted IRR (AIRR) 1.40, 95% CI 1.11-1.77), (2) identifying adaptations while maintaining core components (AIRR 1.28, 95% CI 1.03-1.60), (3) conducting initial training (AIRR 1.16, 95% CI 1.02-1.50), and (4) regularly sharing lessons learned (AIRR 1.32, 95% CI 1.09-1.59). CONCLUSIONS: In this national evaluation of strategies used to implement case reviews of patients at high risk of opioid-related adverse events, point of contact age and tenure in the current role, prior pain-related academic detailing at the facility, and four specific implementation strategies were associated with case review completion rates, while randomization to additional centralized oversight was not. TRIAL REGISTRATION: This project is registered at the ISRCTN Registry with number ISRCTN16012111. The trial was first registered on May 3, 2017.

Associations between stopping prescriptions for opioids, length of opioid treatment, and overdose or suicide deaths in US veterans: observational evaluation.

OBJECTIVE: To examine the associations between stopping treatment with opioids, length of treatment, and death from overdose or suicide in the Veterans Health Administration. DESIGN: Observational evaluation. SETTING: Veterans Health Administration. PARTICIPANTS: 1 394 102 patients in the Veterans Health Administration with an outpatient prescription for an opioid analgesic from fiscal year 2013 to the end of fiscal year 2014 (1 October 2012 to 30 September 2014). MAIN OUTCOME MEASURES: A multivariable Cox non-proportional hazards regression model examined death from overdose or suicide, with the interaction of time varying opioid cessation by length of treatment (≤30, 31-90, 91-400, and >400 days) as the main covariates. Stopping treatment with opioids was measured as the time when a patient was estimated to have no prescription for opioids, up to the end of the next fiscal year (2014) or the patient's death. RESULTS: 2887 deaths from overdose or suicide were found. The incidence of stopping opioid treatment was 57.4% (n=799 668) overall, and based on length of opioid treatment was 32.0% (≤30 days), 8.7% (31-90 days), 22.7% (91-400 days), and 36.6% (>400 days). The interaction between stopping treatment with opioids and length of treatment was significant (P<0.001); stopping treatment was associated with an increased risk of death from overdose or suicide regardless of the length of treatment, with the risk increasing the longer patients were treated. Hazard ratios for patients who stopped opioid treatment (with reference values for all other covariates) were 1.67 (≤30 days), 2.80 (31-90 days), 3.95 (91-400 days), and 6.77 (>400 days). Descriptive life table data suggested that death rates for overdose or suicide increased immediately after starting or stopping treatment with opioids, with the incidence decreasing over about three to 12 months. CONCLUSIONS: Patients were at greater risk of death from overdose or suicide after stopping opioid treatment, with an increase in the risk the longer patients had been treated before stopping. Descriptive data suggested that starting treatment with opioids was also a risk period. Strategies to mitigate the risk in these periods are not currently a focus of guidelines for long term use of opioids. The associations observed cannot be assumed to be causal; the context in which opioid prescriptions were started and stopped might contribute to risk and was not investigated. Safer prescribing of opioids should take a broader view on patient safety and mitigate the risk from the patient's perspective. Factors to address are those that place patients at risk for overdose or suicide after beginning and stopping opioid treatment, especially in the first three months.

Comparison of naloxone prescribing patterns due to educational outreach conducted by full-time and part-time academic detailers at the U.S. Veterans Health Administration.

OBJECTIVE: To examine the impact of full-time equivalent employee (FTEE) allocation to academic detailers on naloxone prescribing at the U.S. Veterans Health Administration (VA). DESIGN: Longitudinal nonequivalent control group posttest-only design using a random effects model. SETTING AND PARTICIPANTS: Closed cohort of primary care providers exposed to academic detailing between September 1, 2016, and September 20, 2018, at VA. OUTCOME MEASURES: Previous analysis identified a cutoff of 0.40 FTEE was associated with a greater return on investment. We evaluated whether this level of FTEE allocation was associated with increases in naloxone prescribing rates and compared providers who had an interaction with an academic detailer allocated 0.4 FTEE or greater (high FTEE) to providers who interacted with an academic detailer allocated less than 0.4 FTEE (low FTEE). RESULTS: Among VA primary care providers who received academic detailing, 1770 (68%) had interactions with a high FTEE academic detailer. There were no differences in demographics between providers who interacted with high FTEE and low FTEE academic detailers except for the distribution of provider classes (P = 0.004) and geographic districts (P < 0.001). Providers who interacted with high FTEE academic detailers had a greater average monthly number of naloxone prescriptions prescribed compared with low FTEE academic detailers (0.60 vs. 0.53; P = 0.005). In the random effects model, there was a 65% greater increase in the average monthly number of naloxone prescriptions prescribed among providers who interacted with a high FTEE academic detailer compared with providers who interacted with low FTEE academic detailers (P = 0.027). We also observed a dose-dependent relationship between the number of naloxone prescribed and the amount of FTEE allocated. CONCLUSION: This observational study highlights the potential benefits (e.g., increased naloxone prescribing) of academic detailers having more FTEE allocated. Hence, implementation of academic detailing needs to consider the amount of dedicated time for academic detailers, given competing VA priorities.