Trends in COVID-19-Related Medication Use in US Nursing Homes, 2018-2022.

OBJECTIVES: Little is known about how COVID-19 treatment patterns have evolved over time in nursing homes (NHs) despite the devastating effects of COVID-19 in this setting. The aim was to describe changes in COVID-19-related medication use over time among NH residents in the United States. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: This study used electronic health records (EHR) from 11 different US NH corporations between January 1, 2018, and March 31, 2022. METHODS: The use of medications approved for COVID-19-related conditions or known to be used off-label for COVID-19 during the study period is identified. We described trends in the use of each drug and combined use per 1000 NH residents over calendar time [quarters (Q)]. RESULTS: A total of 59,022 unique residents with the use of an eligible medication were identified. Hydroxychloroquine use sharply increased from 9.8 in 2020Q1 to 30.2 orders per 1000 individuals in 2020Q2. Dexamethasone use increased sharply from 14.8 in 2020Q2 to a peak of 121.9 orders per 1000 individuals in 2020Q4. Azithromycin use increased from 44.1 in 2019Q3 to a peak of 99.9 orders per 1000 individuals in 2020Q4, with a drop in 2020Q3 of 51.3 per 1000 individuals in 2020Q3. Concurrent use of azithromycin and hydroxychloroquine increased sharply from 0.3 in 2020Q1 to 10.6 orders per 1000 residents in 2020Q2 and then drastically decreased to 0.6 per 1000 residents in 2020Q3. Concurrent use of dexamethasone and azithromycin rose considerably from 0.7 in 2020Q2 to 28.2 orders per 1000 residents in 2020Q4. CONCLUSIONS AND IMPLICATIONS: As in other settings, COVID-19-related medication use in NHs appears to have changed in response to the shifting evidence base and availability of medications during the pandemic. Providers should continue to diligently modify their prescribing as new evidence accrues.

Infections, Hospitalizations, and Deaths Among US Nursing Home Residents With vs Without a SARS-CoV-2 Vaccine Booster.

Importance: A SARS-CoV-2 vaccine booster dose has been recommended for all nursing home residents. However, data on the effectiveness of an mRNA vaccine booster in preventing infection, hospitalization, and death in this vulnerable population are lacking. Objective: To evaluate the association between receipt of a SARS-CoV-2 mRNA vaccine booster and prevention of infection, hospitalization, or death among nursing home residents. Design, Setting, and Participants: This cohort study emulated sequentially nested target trials for vaccination using data from 2 large multistate US nursing home systems: Genesis HealthCare, a community nursing home operator (system 1) and Veterans Health Administration community living centers (VHA CLCs; system 2). The cohort included long-term (≥100 days) nursing home residents (10 949 residents from 202 community nursing homes and 4321 residents from 128 VHA CLCs) who completed a 2-dose series of an mRNA vaccine (either BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) and were eligible for a booster dose between September 22 and November 30, 2021. Residents were followed up until March 8, 2022. Exposures: Receipt of a third mRNA vaccine dose, defined as a booster dose (boosted group), or nonreceipt of a booster dose (unboosted group) on an eligible target trial date. If participants in the unboosted group received a booster dose on a later target trial date, they were included in the booster group for that target trial; thus, participants could be included in both the boosted and unboosted groups. Main Outcomes and Measures: Test-confirmed SARS-CoV-2 infection, hospitalization, or death was followed up to 12 weeks after booster vaccination. The primary measure of estimated vaccine effectiveness was the ratio of cumulative incidences in the boosted group vs the unboosted group at week 12, adjusted with inverse probability weights for treatment and censoring. Results: System 1 included 202 community nursing homes; among 8332 boosted residents (5325 [63.9%] female; 6685 [80.2%] White) vs 10 886 unboosted residents (6865 [63.1%] female; 8651 [79.5%] White), the median age was 78 (IQR, 68-87) years vs 78 (IQR, 68-86) years. System 2 included 128 VHA CLCs; among 3289 boosted residents (3157 [96.0%] male; 1950 [59.3%] White) vs 4317 unboosted residents (4151 [96.2%] male; 2434 [56.4%] White), the median age was 74 (IQR, 70-80) vs 74 (IQR, 69-80) years. Booster vaccination was associated with reductions in SARS-CoV-2 infections of 37.7% (95% CI, 25.4%-44.2%) in system 1 and 57.7% (95% CI, 43.5%-67.8%) in system 2. For hospitalization, reductions of 74.4% (95% CI, 44.6%-86.2%) in system 1 and 64.1% (95% CI, 41.3%-76.0%) in system 2 were observed. Estimated vaccine effectiveness for death associated with SARS-CoV-2 was 87.9% (95% CI, 75.9%-93.9%) in system 1; however, although a reduction in death was observed in system 2 (46.6%; 95% CI, -34.6% to 94.8%), this reduction was not statistically significant. A total of 45 SARS-CoV-2-associated deaths occurred in system 1 and 18 deaths occurred in system 2. For the combined end point of SARS-CoV-2-associated hospitalization or death, boosted residents in system 1 had an 80.3% (95% CI, 65.7%-88.5%) reduction, and boosted residents in system 2 had a 63.8% (95% CI, 41.4%-76.1%) reduction. Conclusions and Relevance: In this study, during a period in which both the Delta and Omicron variants were circulating, SARS-CoV-2 booster vaccination was associated with significant reductions in SARS-CoV-2 infections, hospitalizations, and the combined end point of hospitalization or death among residents of 2 US nursing home systems. These findings suggest that administration of vaccine boosters to nursing home residents may have an important role in preventing COVID-19-associated morbidity and mortality.

Correlation of long-term care facility vaccination practices between seasons and resident types.

BACKGROUND: Influenza vaccination varies widely across long-term care facilities (LTCFs) due to staff behaviors, LTCF practices, and patient factors. It is unclear how seasonal LTCF vaccination varies between cohabitating but distinct short-stay and long-stay residents. Thus, we assessed the correlation of LTCF vaccination between these populations and across seasons. METHODS: The study design is a national retrospective cohort using Medicare and Minimum Data Set (MDS) data. Participants include U.S. LTCFs. Short-stay and long-stay Medicare-enrolled residents age ≥ 65 in U.S. LTCFs from a source population of residents during October 1^st-March 31^st in 2013-2014 (3,042,881 residents; 15,683 LTCFs) and 2014-2015 (3,143,174, residents; 15,667 LTCFs). MDS-assessed influenza vaccination was the outcome. Pearson correlation coefficients were estimated to assess seasonal correlations between short-stay and long-stay resident vaccination within LTCFs. RESULTS: The median proportion of short-stay residents vaccinated across LTCFs was 70.4% (IQR, 50.0-82.7%) in 2013-2014 and 69.6% (IQR, 50.0-81.6%) in 2014-2015. The median proportion of long-stay residents vaccinated across LTCFs was 85.5% (IQR, 78.0-90.9%) in 2013-2014 and 84.6% (IQR, 76.6-90.3%) in 2014-2015. Within LTCFs, there was a moderate correlation between short-stay and long-stay vaccination in 2013-2014 (r = 0.50, 95%CI: 0.49-0.51) and 2014-2015 (r = 0.53, 95%CI: 0.51-0.54). Across seasons, there was a moderate correlation for LTCFs with short-stay residents (r = 0.54, 95%CI: 0.53-0.55) and a strong correlation for those with long-stay residents (r = 0.68, 95%CI: 0.67-0.69). CONCLUSIONS: In LTCFs with inconsistent influenza vaccination across seasons or between populations, targeted vaccination protocols for all residents, regardless of stay type, may improve successful vaccination in this vulnerable patient population.

Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents - 19 States, March 29-July 25, 2022.

Nursing home residents continue to experience significant COVID-19 morbidity and mortality (1). On March 29, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended a second mRNA COVID-19 vaccine booster dose for adults aged ≥50 years and all immunocompromised persons who had received a first booster ≥4 months earlier.* On September 1, 2022, ACIP voted to recommend bivalent mRNA COVID-19 vaccine boosters for all persons aged ≥12 years who had completed the primary series using monovalent vaccines ≥2 months earlier (2). Data on COVID-19 booster dose vaccine effectiveness (VE) in the nursing home population are limited (3). For this analysis, academic, federal, and private partners evaluated routine care data collected from 196 U.S. community nursing homes to estimate VE of a second mRNA COVID-19 vaccine booster dose among nursing home residents who had received 3 previous COVID-19 vaccine doses (2 primary series doses and 1 booster dose). Residents who received second mRNA COVID-19 vaccine booster doses during March 29-June 15, 2022, with follow-up through July 25, 2022, were found to have 60-day VE of 25.8% against SARS-CoV-2 (the virus that causes COVID-19 infection), 73.9% against severe COVID-19 outcomes (a combined endpoint of COVID-19-associated hospitalizations or deaths), and 89.6% against COVID-19-associated deaths alone. During this period, subvariants BA.2 and BA.2.12.1 (March-June 2022), and BA.4 and BA.5 (July 2022) of the B.1.1.529 and BA.2 (Omicron) variant were predominant. These findings suggest that among nursing home residents, second mRNA COVID-19 vaccine booster doses provided additional protection over first booster doses against severe COVID-19 outcomes during a time of emerging Omicron variants. Facilities should continue to ensure that nursing home residents remain up to date with COVID-19 vaccination, including bivalent vaccine booster doses, to prevent severe COVID-19 outcomes.

Relationships Between Community Virus Activity and Cardiorespiratory Rehospitalizations From Post-Acute Care.

OBJECTIVES: Quantify the relationship between increasing influenza and respiratory syncytial virus (RSV) community viral activity and cardiorespiratory rehospitalizations among older adults discharged to skilled nursing facilities (SNFs). DESIGN: Retrospective cohort. SETTING AND PARTICIPANTS: Adults aged ≥65 years who were hospitalized and then discharged to a US SNF between 2012 and 2015. METHODS: We linked Medicare Provider Analysis and Review claims to Minimum Data Set version 3.0 assessments, PRISM Climate Group data, and the Centers for Disease Control and Prevention viral testing data. All data were aggregated to US Department of Health and Human Services regions. Negative binomial regression models quantified the relationship between increasing viral activity for RSV and 3 influenza strains (H1N1pdm09, H3N2, and B) and cardiorespiratory rehospitalizations from SNFs. Incidence rate ratios described the relationship between a 5% increase in circulating virus and the rates of rehospitalization for cardiorespiratory outcomes. Analyses were repeated using the same model, but influenza and RSV were considered "in season" or "out of season" based on a 10% positive testing threshold. RESULTS: Cardiorespiratory rehospitalization rates increased by approximately 1% for every 5% increase in circulating influenza A(H3N2), influenza B, and RSV, but decreased by 1% for every 5% increase in circulating influenza A(H1N1pdm09). When respiratory viruses were in season (vs out of season), cardiorespiratory rehospitalization rates increased by approximately 6% for influenza A(H3N2), 3% for influenza B, and 5% for RSV, but decreased by 6% for influenza A(H1N1pdm09). CONCLUSIONS AND IMPLICATIONS: The respiratory season is a particularly important period to implement interventions that reduce cardiorespiratory hospitalizations among SNF residents. Decreasing viral transmission in SNFs through practices such as influenza vaccination for residents and staff, use of personal protective equipment, improved environmental cleaning measures, screening and testing of residents and staff, surveillance of viral activity, and quarantining infected individuals may be potential strategies to limit viral infections and associated cardiorespiratory rehospitalizations.

Electronic Health Records to Rapidly Assess Biosimilar Uptake: An Example Using Insulin Glargine in a Large U.S. Nursing Home Cohort.

Large healthcare administrative databases, like Medicare claims, are a common means to evaluate drug policies. However, administrative data often have a lag time of months to years before they are available to researchers and decision-makers. Therefore, administrative data are not always ideal for timely policy evaluations. Other sources of data are needed to rapidly evaluate policy changes and inform subsequent studies that utilize large administrative data once available. An emerging area of interest in both pharmacoepidemiology and drug policy research that can benefit from rapid data availability is biosimilar uptake, due to the potential for substantial cost savings. To respond to the need for such a data source, we established a public-private partnership to create a near-real-time database of over 1,000 nursing homes' electronic health records to describe and quantify the effects of recent policies related to COVID-19 and medications. In this article, we first describe the components and infrastructure used to create our EHR database. Then, we provide an example that illustrates the use of this database by describing the uptake of insulin glargine-yfgn, a new exchangeable biosimilar for insulin glargine, in US nursing homes. We also examine the uptake of all biosimilars in nursing homes before and after the onset of the COVID-19 pandemic. We conclude with potential directions for future research and database infrastructure.

ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs.

As the scientific research community along with healthcare professionals and decision makers around the world fight tirelessly against the coronavirus disease 2019 (COVID-19) pandemic, the need for comparative effectiveness research (CER) on preventive and therapeutic interventions for COVID-19 is immense. Randomized controlled trials markedly under-represent the frail and complex patients seen in routine care, and they do not typically have data on long-term treatment effects. The increasing availability of electronic health records (EHRs) for clinical research offers the opportunity to generate timely real-world evidence reflective of routine care for optimal management of COVID-19. However, there are many potential threats to the validity of CER based on EHR data that are not originally generated for research purposes. To ensure unbiased and robust results, we need high-quality healthcare databases, rigorous study designs, and proper implementation of appropriate statistical methods. We aimed to describe opportunities and challenges in EHR-based CER for COVID-19-related questions and to introduce best practices in pharmacoepidemiology to minimize potential biases. We structured our discussion into the following topics: (1) study population identification based on exposure status; (2) ascertainment of outcomes; (3) common biases and potential solutions; and (iv) data operational challenges specific to COVID-19 CER using EHRs. We provide structured guidance for the proper conduct and appraisal of drug and vaccine effectiveness and safety research using EHR data for the pandemic. This paper is endorsed by the International Society for Pharmacoepidemiology (ISPE).

Variation in influenza vaccine assessment, receipt, and refusal by the concentration of Medicare Advantage enrollees in U.S. nursing homes.

BACKGROUND: More older adults enrolled in Medicare Advantage (MA) are entering nursing homes (NHs), and MA concentration could affect vaccination rates through shifts in resident characteristics and/or payer-related influences on preventive services use. We investigated whether rates of influenza vaccination and refusal differ across NHs with varying concentrations of MA-enrolled residents. METHODS: We analyzed 2014-2015 Medicare enrollment data and Minimum Data Set clinical assessments linked to NH-level characteristics, star ratings, and county-level MA penetration rates. The independent variable was the percentage of residents enrolled in MA at admission and categorized into three equally-sized groups. We examined three NH-level outcomes including the percentages of residents assessed and appropriately considered for influenza vaccination, received influenza vaccination, and refused influenza vaccination. RESULTS: There were 936,513 long-stay residents in 12,384 NHs. Categories for the prevalence of MA enrollment in NHs were low (0% to 3.3%; n = 4131 NHs), moderate (3.4% to 18.6%; n = 4127 NHs) and high (>18.6%; n = 4126 NHs). Overall, 81.3% of long-stay residents received influenza vaccination and 14.3% refused the vaccine when offered. Adjusting for covariates, influenza vaccination rates among long-stay residents were higher in NHs with moderate (1.70 percentage points [pp], 95% confidence limits [CL]: 1.15 pp, 2.24 pp), or high (3.05 pp, 95% CL: 2.45 pp, 3.66 pp) MA versus the lowest prevalence of MA. Influenza vaccine refusal was lower in NHs with moderate (-3.10 pp, 95% CL: -3.53 pp, -2.68 pp), or high (-4.63 pp, 95% CL: -5.11 pp, -4.15 pp) MA compared with NHs with the lowest prevalence of MA. CONCLUSION: A higher concentration of long-stay NH residents enrolled in MA was associated with greater influenza vaccine receipt and lower vaccine refusal. As MA becomes a larger share of the Medicare program, and more MA beneficiaries enter NHs, decisionmakers need to consider how managed care can be leveraged to improve the delivery of preventive services like influenza vaccinations in NH settings.

Lessons for deprescribing from a nonessential medication hold policy in US nursing homes.

BACKGROUND: At the height of the COVID-19 pandemic, a large nursing home chain implemented a policy to temporarily hold potentially unnecessary medications. We describe rates of held and discontinued medications after a temporary hold policy of potentially unnecessary or nonessential medications. METHODS: This retrospective cohort study uses electronic health record (EHR) data on 3247 residents of 64 nursing homes operated by a multistate long-term care provider. Medications were documented in the electronic medication administration record. Overall medication held and discontinued incidences are reported. Hierarchical Bayesian modeling is used to determine individual probabilities for medication discontinuation within each facility. RESULTS: In total, 3247 residents had 5297 nonessential medications held. Multivitamins were most likely to be held, followed by histamine-2 receptor antagonists, antihistamines, and statins. At the end of the hold policy, 2897 of 5297 (54%) were permanently discontinued, including probiotics (73%), histamine-2 receptor antagonists (66%), antihistamines (64%), and statins (45%). Demographics, cognitive and functional impairment were similar between residents with medications who were discontinued versus continued. For most medications, more than 50% of the variance in whether medications were discontinued was explained by facility rather than resident-level factors. CONCLUSION: A temporary medication hold policy implemented during the CoVID-19 pandemic led to the deprescribing of a plurality of 'nonessential' medications. This type of organization-wide initiative may be an effective mechanism for altering future prescribing behaviors to reduce the use of unnecessary medications.