Changes in Physical Function and Physical Therapy Use in Older Veterans Not Infected by CoVID-19 Residing in Community Living Centers during the CoVID-19 Pandemic.

OBJECTIVES: Examine physical function change and physical therapy (PT) use in short-stay and long-stay residents not infected by CoVID-19 within Veterans Affairs (VA) Community Living Centers (CLCs). DESIGN: Retrospective cohort study using Minimum Data Set (MDS) 3.0 assessments. SETTINGS AND PARTICIPANTS: 12,606 Veterans in 133 VA CLCs between September 2019 and September 2020. METHODS: Difference in physical function [MDS Activities of Daily Living Score (MDS-ADL)] and PT use (minutes in past 7 days) from admission to last assessment in a period were compared between the pre-CoVID-19 (September 2019 to February 2020) and early CoVID-19 (April 2020 to September 2020) period using mixed effects regression with multivariable adjustment. Assessments after a positive CoVID-19 test were excluded. Differences were examined in the sample and repeated after stratifying into short- and long-stay stratums. RESULTS: Veterans admitted during early CoVID-19 had more comorbidities, worse MDS-ADL scores, and were more often long-stay residents compared with those admitted during pre-CoVID-19. In comparison to pre-CoVID-19, Veterans in VA CLCs during early CoVID-19 experienced greater improvements in their MDS-ADL (-0.49 points, 95% CI -0.27, -0.71) and received similar minutes of therapy (2.6 minutes, 95% CI -0.8, 6.0). Stratification revealed short-stay residents had relative improvements in their function (-0.69 points, 95% CI -0.44, -0.94) and higher minutes of PT (5.1 minutes, 95% CI 0.9, 9.2) during early CoVID-19 whereas long-stay residents did not see differences in functional change (0.08 points, 95% CI -0.36, 0.51) or PT use (-0.6 minutes, 95% CI -6.1, 4.9). CONCLUSIONS AND IMPLICATIONS: During early CoVID-19, physical function improved while the amount of PT received was maintained compared with pre-CoVID-19 for Veterans in VA CLCs. Short-stay residents experienced greater improvements in physical function and increases in PT use. These findings may be partly due to selection bias relating to Veterans admitted to CLCs during early CoVID-19.

Durability of immunity and clinical protection in nursing home residents following bivalent SARS-CoV-2 vaccination.

BACKGROUND: Bivalent SARS-CoV-2 vaccines were developed to counter increasing susceptibility to emerging SARS-CoV-2 variants. We evaluated the durability of immunity and protection following first bivalent vaccination among nursing home residents. METHODS: We evaluated anti-spike and neutralization titers from blood in 653 community nursing home residents before and after each monovalent booster, and a bivalent vaccine. Concurrent clinical outcomes were evaluated using electronic health record data from a separate cohort of 3783 residents of Veterans Affairs (VA) nursing homes who had received at least the primary series monovalent vaccination. Using target trial emulation, we compared VA residents who did and did not receive the bivalent vaccine to measure vaccine effectiveness against infection, hospitalization, and death. FINDINGS: In the community cohort, Omicron BA.5 neutralization activity rose after each monovalent and bivalent booster vaccination regardless of prior infection history. Titers declined over time but six months post-bivalent vaccination, BA.5 neutralization persisted at detectable levels in 75% of infection-naive and 98% of prior-infected individuals. In the VA nursing home cohort, bivalent vaccine added effectiveness to monovalent booster vaccination by 18.5% for infection (95% confidence interval (CI) -5.6, 34.0%), and 29.2% for hospitalization or death (95% CI -14.2, 56.2%) over five months. INTERPRETATION: The level of protection declined after bivalent vaccination over a 6 month period and may open a window of added vulnerability before the next updated vaccine becomes available, suggesting a subset of nursing home residents may benefit from an additional vaccination booster. FUNDING: CDC, NIH, VHA.

Wandering Behavior and SARS-CoV-2 Infection in Veterans Affairs Community Living Center Residents.

OBJECTIVE: Wandering behavior in nursing home (NH) residents could increase risk of infection. The objective of this study was to assess the association of wandering behavior with SARS-CoV-2 infection in Veterans Affairs (VA) Community Living Center (CLC) residents. DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Veterans residing in 133 VA CLCs. METHODS: We included residents with SARS-CoV-2 test from March 1, 2020 to December 31, 2020 from VA electronic medical records. We identified CLC residents with wandering on Minimum Data Set 3.0 assessments and compared them with residents without wandering. The outcome was SARS-CoV-2 infection, as tested for surveillance testing, in those with and without wandering. Generalized linear model with Poisson link adjusted for relevant covariates was used. RESULTS: Residents (n = 9995) were included in the analytic cohort mean, (SD) age 73.4 (10.7); 388 (3.9%) women. The mean (SD) activities of daily living score in the overall cohort was 13.6 (8.25). Wandering was noted in 379 (3.8%) (n = 379) of the cohort. The exposure groups differed in prior dementia (92.6% vs 62.1%, standardized mean difference [SMD] = 0.8) and psychoses (41.4% vs 28.1%, SMD = 0.3). Overall, 12.5% (n = 1248) tested positive for SARS-CoV-2 and more residents among the wandering group were SARS-CoV-2 positive as compared with those in the group without wandering (19% [n = 72] vs 12.2% [n = 1176], SMD = 0.19). Adjusting for covariates, residents with wandering had 34% higher relative risk for SARS-CoV-2 infection (adjusted relative risk, 1.34; 95% CI, 1.04-1.69). CONCLUSIONS AND IMPLICATIONS: CLC residents with wandering had a higher risk of SARS-CoV-2 infection. This may inform implementation of infection control and isolation policies as NHs attempt to balance ethical concepts of resident autonomy, proportionality, equity, and utilitarianism.

Early Mortality After the First Dose of COVID-19 Vaccination: A Target Trial Emulation.

BACKGROUND: Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans. METHODS: We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects. RESULTS: We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1). CONCLUSIONS: Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

Facilitators and Barriers to Verifying Penicillin Allergies in a Veteran Nursing Home Population.

BACKGROUND: Unconfirmed penicillin allergies are common and may contribute to adverse outcomes, especially in frail older patients. Evidence-based clinical pathways for evaluating penicillin allergies have been effectively and safely applied in selected settings, but not in nursing home populations. OBJECTIVE: To identify potential facilitators and barriers to implementing a strategy to verify penicillin allergies in Veterans Health Administration nursing homes, known as Community Living Centers (CLCs). METHODS: We conducted semistructured interviews with staff, patients, and family members at 1 CLC to assess their understanding of penicillin allergies and receptiveness to verifying the allergy. We also asked staff about the proposed allergy assessment strategy, including willingness to delabel by history and feasibility of performing oral challenges or skin testing on their unit. RESULTS: From 24 interviews (11 front-line staff, 4 leadership, 3 patients, 6 family members), we identified several facilitators or barriers. Staff recognized the importance of allergy verification and were willing to support and assist in implementing verification strategies. The CLC residents were willing to have their allergy status verified. However, some family members expressed reluctance to verifying their relative's allergy status owing to safety concerns. Front-line staff also expressed concern over having the necessary resources, including time and expertise, to implement the strategy. Staff suggested involving clinical pharmacists and educating staff, patients, and family members as ways to overcome these barriers. CONCLUSIONS: Concerns about safety and staff resources are important potential barriers to implementing verification strategies. Involvement of pharmacists and education of both staff and patients and family members will be important components of any successful intervention.

Durability of immunity and clinical protection in nursing home residents following bivalent SARS-CoV-2 vaccination.

Background: Vaccines have substantially mitigated the disproportional impact of SARS-CoV-2 on the high morbidity and mortality experienced by nursing home residents. However, variation in vaccine efficacy, immune senescence and waning immunity all undermine vaccine effectiveness over time. The introduction of the bivalent vaccine in September 2022 aimed to counter this increasing susceptibility and consequences of breakthrough infection, however data on the durability and protection of the vaccine are limited. We evaluated the durability of immunity and protection after the first bivalent vaccination to SARS-CoV-2 in nursing home residents. Methods: For the immunologic evaluation, community nursing home volunteers agreed to serial blood sampling before, at two weeks, three and six months after each vaccination for antibodies to spike protein and pseudovirus neutralization activity over time. Concurrent clinical outcomes were evaluated by reviewing electronic health record data from residents living in Veterans Administration managed nursing home units. Residents without recent infection but prior vaccination to SARS-CoV-2 were followed over time beginning with administration of the newly available bivalent vaccine using a target trial emulation (TTE) approach; TTE compared time to breakthrough infection, hospitalization and death between those who did and did not receive the bivalent vaccine. Results: We evaluated antibodies in 650 nursing home residents; 452 had data available following a first monovalent booster, 257 following a second monovalent booster and 321 following a bivalent vaccine. We found a rise in BA.5 neutralization activity from the first and second monovalent boosters through the bivalent vaccination regardless of prior SARS-CoV-2 history. Titers declined at three and six months after the bivalent vaccination but generally exceeded those at three months compared to either prior boost. BA.5 neutralization titers six months after the bivalent vaccination were diminished but had detectable levels in 80% of infection-naive and 100% of prior infected individuals. TTE evaluated 5903 unique subjects, of whom 2235 received the bivalent boost. TTE demonstrated 39% or greater reduction in risk of infection, hospitalization or death at four months following the bivalent boost. Conclusion: Immunologic results mirrored those of the TTE and suggest bivalent vaccination added substantial protection for up to six months after bivalent vaccination with notable exceptions. However, the level of protection declined over this period, and by six months may open a window of added vulnerability to infection before the next updated vaccine becomes available. We strongly agree with the CDC recommendation that those who have not received a bivalent vaccination receive that now and these results support a second bivalent booster for those at greatest risk which includes many nursing home residents.

Predicting Seasonal Influenza Hospitalizations Using an Ensemble Super Learner: A Simulation Study.

Accurate forecasts can inform response to outbreaks. Most efforts in influenza forecasting have focused on predicting influenza-like activity, with fewer on influenza-related hospitalizations. We conducted a simulation study to evaluate a super learner's predictions of 3 seasonal measures of influenza hospitalizations in the United States: peak hospitalization rate, peak hospitalization week, and cumulative hospitalization rate. We trained an ensemble machine learning algorithm on 15,000 simulated hospitalization curves and generated weekly predictions. We compared the performance of the ensemble (weighted combination of predictions from multiple prediction algorithms), the best-performing individual prediction algorithm, and a naive prediction (median of a simulated outcome distribution). Ensemble predictions performed similarly to the naive predictions early in the season but consistently improved as the season progressed for all prediction targets. The best-performing prediction algorithm in each week typically had similar predictive accuracy compared with the ensemble, but the specific prediction algorithm selected varied by week. An ensemble super learner improved predictions of influenza-related hospitalizations, relative to a naive prediction. Future work should examine the super learner's performance using additional empirical data on influenza-related predictors (e.g., influenza-like illness). The algorithm should also be tailored to produce prospective probabilistic forecasts of selected prediction targets.

Class II/III Obesity Prevalence in Residents of US Nursing Homes: Cross-sectional Study and Forecasting 2030 with COVID-19 Perspective.

OBJECTIVES: This study aimed to better understand Class II/III obesity prevalence trends among older adults residing in nursing homes (NH) nationwide. METHODS: Our retrospective cross-sectional study evaluated Class II/III obesity (BMI ≥35 kg/m²) prevalence among NH residents in two independent national NH cohorts. We used databases from Veterans Administration NHs called Community Living Centers (CLCs) covering 7 years to 2022, and Rhode Island Medicare data covering 20 years ending in 2020. We also performed forecasting regression analysis of obesity trends. RESULTS: While VA CLC resident obesity prevalence was less overall and dipped during the COVID-19 pandemic, obesity prevalence increased in NH residents in both cohorts over the last decade and is predicted to do so through 2030. CONCLUSION: Obesity prevalence in NHs is on the rise. It will be important to understand clinical, functional, and financial implications for NHs, particularly if predictions on increases materialize.

The validity of causal claims with repeated measures designs: A within-study comparison evaluation of differences-in-differences and the comparative interrupted time series.

Modern policies are commonly evaluated not with randomized experiments but with repeated measures designs like difference-in-differences (DID) and the comparative interrupted time series (CITS). The key benefit of these designs is that they control for unobserved confounders that are fixed over time. However, DID and CITS designs only result in unbiased impact estimates when the model assumptions are consistent with the data at hand. In this paper, we empirically test whether the assumptions of repeated measures designs are met in field settings. Using a within-study comparison design, we compare experimental estimates of the impact of patient-directed care on medical expenditures to non-experimental DID and CITS estimates for the same target population and outcome. Our data come from a multi-site experiment that includes participants receiving Medicaid in Arkansas, Florida, and New Jersey. We present summary measures of repeated measures bias across three states, four comparison groups, two model specifications, and two outcomes. We find that, on average, bias resulting from repeated measures designs are very close to zero (less than 0.01 standard deviations; SDs). Further, we find that comparison groups which have pre-treatment trends that are visibly parallel to the treatment group result in less bias than those with visibly divergent trends. However, CITS models that control for baseline trends produced slightly more bias and were less precise than DID models that only control for baseline means. Overall, we offer optimistic evidence in favor of repeated measures designs when randomization is not feasible.

SARS-CoV-2 Antibody Responses to the Ancestral SARS-CoV-2 Strain and Omicron BA.1 and BA.4/BA.5 Variants in Nursing Home Residents After Receipt of Bivalent COVID-19 Vaccine - Ohio and Rhode Island, September-November 2022.

Introduction of monovalent COVID-19 mRNA vaccines in late 2020 helped to mitigate disproportionate COVID-19-related morbidity and mortality in U.S. nursing homes (1); however, reduced effectiveness of monovalent vaccines during the period of Omicron variant predominance led to recommendations for booster doses with bivalent COVID-19 mRNA vaccines that include an Omicron BA.4/BA.5 spike protein component to broaden immune response and improve vaccine effectiveness against circulating Omicron variants (2). Recent studies suggest that bivalent booster doses provide substantial additional protection against SARS-CoV-2 infection and severe COVID-19-associated disease among immunocompetent adults who previously received only monovalent vaccines (3).* The immunologic response after receipt of bivalent boosters among nursing home residents, who often mount poor immunologic responses to vaccines, remains unknown. Serial testing of anti-spike protein antibody binding and neutralizing antibody titers in serum collected from 233 long-stay nursing home residents from the time of their primary vaccination series and including any subsequent booster doses, including the bivalent vaccine, was performed. The bivalent COVID-19 mRNA vaccine substantially increased anti-spike and neutralizing antibody titers against Omicron sublineages, including BA.1 and BA.4/BA.5, irrespective of previous SARS-CoV-2 infection or previous receipt of 1 or 2 booster doses. These data, in combination with evidence of low uptake of bivalent booster vaccination among residents and staff members in nursing homes (4), support the recommendation that nursing home residents and staff members receive a bivalent COVID-19 booster dose to reduce associated morbidity and mortality (2).

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.

High-dose influenza vaccines for the prevention of hospitalization due to cardiovascular events in older adults in the nursing home: Post-hoc analysis of a cluster-randomized trial.

Older adults are at high risk of major acute cardiovascular events (MACE) linked to influenza illness andpreventable by influenza vaccination. It is unknown whether high-dose vaccine might incrementally reduce the risk of MACE.We conducted a post-hoc analysis of data collected from a pragmatic cluster randomized study of 823 nursing homes (NH) randomized to standard-dose (SD) or high-dose (HD) influenza vaccine in the 2013-14 season. Adults age 65 year or older who are Medicare-enrolled long-stay residents were included in the analysis.There were no statistically significant differences in hospitalization for MACE, acute coronary syndromes (ACS), stroke or heart failure between the HD and SD arms. However, in the fee-for-service group, participants in the HD arm had significantly decreased risk of hospitalization for respiratory problems, which was not observed in the Medicare Advantage group.High-dose influenza vaccine was not shown to be incrementally protective against MACE relative to standard-dose vaccine.

Cardiac Rehabilitation and the COVID-19 Pandemic: Persistent Declines in Cardiac Rehabilitation Participation and Access Among US Medicare Beneficiaries.

BACKGROUND: The impact of the COVID-19 pandemic on participation in and availability of cardiac rehabilitation (CR) is unknown. METHODS: Among eligible Medicare fee-for-service beneficiaries, we evaluated, by month, the number of CR sessions attended per 100 000 beneficiaries, individuals eligible to initiate CR, and centers offering in-person CR between January 2019 and December 2021. We compared these outcomes between 2 periods: December 1, 2019 through February 28, 2020 (period 1, before declaration of the pandemic-related national emergency) and October 1, 2021 through December 31, 2021 (period 2, the latest period for which data are currently available). RESULTS: In period 1, Medicare beneficiaries participated in (mean±SD) 895±84 CR sessions per 100 000 beneficiaries each month. After the national emergency was declared, CR participation sharply declined to 56 CR sessions per 100 000 beneficiaries in April 2020. CR participation recovered gradually through December 2021 but remained lower than prepandemic levels (period 2: 698±29 CR sessions per month per 100 000 beneficiaries, P=0.02). Declines in CR participation were most marked among dual Medicare and Medicaid enrollees and patients residing in rural areas or socially vulnerable communities. There was no statistically significant change in CR eligibility between the 2 periods. Compared with 2618±5 CR centers in period 1, there were 2464±7 in period 2 (P<0.01). Compared with CR centers that survived the pandemic, 220 CR centers that closed were more likely to be affiliated with public hospitals, located in rural areas, and serve the most socially vulnerable communities. CONCLUSIONS: The COVID-19 pandemic was associated with a persistent decline in CR participation and the closure of CR centers, which disproportionately affected rural and low-income patients and the most socially vulnerable communities. Innovation in CR financing and delivery is urgently needed to equitably enhance CR participation among Medicare beneficiaries.

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.

Can we use temperature measurements to identify pre-symptomatic SARS-CoV-2 infection in nursing home residents?

BACKGROUND: COVID-19 has had a severe impact on morbidity and mortality among nursing home (NH) residents. Earlier detection of SARS-CoV-2 may position us to better mitigate the risk of spread. Both asymptomatic and pre-symptomatic transmission are common in outbreaks, and threshold temperatures, such as 38C, for screening for infection could miss timely detection in the majority of residents. We hypothesized that in long-term care residents, temperature trends with SARS-CoV-2 infection could identify infection in pre-symptomatic individuals earlier than standard screening. METHODS: We conducted a retrospective cohort study using electronic health records in 6176 residents of the VA NHs who underwent SARS-CoV-2 testing triggered by symptoms. We collected information about age and other demographics, baseline temperature, and specific comorbidities. We created standardized definitions, and a hypothetical model to test measures of temperature variation and compare outcomes to the VA standard of care. RESULTS: We showed that a change from baseline of 0.4C identified 47% of NH residents who became SARS-CoV-2 positive, earlier than standard testing by an average of 42.2 h. Temperature variability of 0.5C over 3 days when paired with a 37.2C temperature cutoff identified 55% of NH residents who became SARS-CoV-2 positive earlier than the standard of care testing by an average of 44.4 h. A change from baseline temperature of 0.4C when combined with temperature variability of 0.7C over 3 days identified 52% of NH residents who became SARS-CoV-2 positive, earlier than standard testing by an average of 40 h, and by more than 3 days in 22% of the residents. This earlier detection comes at the expense of triggering 57,793 tests, as compared to the number of trigger tests ordered in the VA system of 40,691. CONCLUSIONS: Our model suggests that early temperature trends with SARS-CoV-2 infection may identify infection in pre-symptomatic long-term care residents.

Dementia prevalence, a contextual factor associated with SARS-CoV-2 in veterans affairs community living centers.

BACKGROUND: Alzheimer's disease and related dementias (ADRD) impact the diagnosis and infection control of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in nursing homes (NH) by influencing the behavior of residents and their caregivers. Health system data show an association between ADRD and SARS-CoV-2. Whether this association is present in NH populations remains unknown. How increased SARS-CoV-2 risk among residents with ADRD impacts the greater NH population also remains unknown. METHODS: This retrospective cohort study used electronic health record data on Veterans residing in 133 Veterans Affairs Community Living Centers (CLC) and 15 spinal cord injury units from March 1, 2020 to December 13, 2020. We measured ADRD using diagnostic codes 12 months before an index SARS-CoV-2 test date for each resident. We used Poisson regression to determine the relative risk of SARS-CoV-2 for the highest quartile of facility ADRD prevalence versus the lowest, stratifying by individual ADRD status, and adjusting for covariates, with and without a random intercept to account for facility clustering. RESULTS: Across the study period, 15,043 residents resided in CLCs, 1952 (13.0%) had SARS-CoV-2, and 8067 (53.6%) had ADRD. There was an estimated 60% increased risk of SARS-CoV-2 in facilities with highest dementia prevalence versus lowest (relative risk, 1.6 [95% confidence interval 0.95, 2.7]). CONCLUSIONS: CLC residents had a greater likelihood of SARS-CoV-2 infection in facilities with greater ADRD prevalence. Facility characteristics other than ADRD prevalence may account for this association.

Adverse events following third dose of mRNA COVID-19 vaccination among nursing home residents who received the primary series.

BACKGROUND: We sought to compare rates of adverse events among nursing home residents who received an mRNA COVID-19 vaccine booster dose with those who had not yet received their booster. METHODS: We assessed a prospective cohort of 11,200 nursing home residents who received a primary COVID-19 mRNA vaccine series at least 6 months prior to September 22, 2021 and received a third "booster dose" between September 22, 2021 and February 2, 2022. Residents lived in 239 nursing homes operated by Genesis HealthCare, spanning 21 U.S. states. We screened electronic health records for 20 serious vaccine-related adverse events that are monitored following receipt of COVID-19 vaccination by the CDC's Vaccine Safety Datalink. We matched boosted and yet-to-be boosted residents during the same time period, comparing rates of events occurring 14 days after booster administration with those occurring 14 days prior to booster administration. To supplement previously reported background rates of adverse events, we report background rates of medical conditions among nursing home residents during 2020, before COVID-19 vaccines were administered in nursing homes. Events occurring in 2021-2022 were confirmed by physician chart review. We report unadjusted rates of adverse events and used a false discovery rate procedure to adjust for multiplicity of events tested. RESULTS: No adverse events were reported during the 14 days post-booster. A few adverse events occurred prior to booster (ischemic stroke: 49.4 per 100,000 residents, 95% CI: 21.2, 115.7; venous thromboembolism: 9.9 per 100,000 residents, 95% CI: 1.7, 56.0), though differences in event rates pre- versus post-booster were not statistically significant (p < 0.05) after adjusting for multiple comparisons. No significant differences were detected between post-booster vaccination rates and prior year 14-day background rates of medical conditions. CONCLUSIONS: No safety signals were detected following a COVID-19 mRNA vaccine booster dose in this large multi-state sample of nursing home residents.

Repurposing Probenecid for the Treatment of Heart Failure (Re-Prosper-HF): a study protocol for a randomized placebo-controlled clinical trial.

BACKGROUND: Improving contractility in heart failure with reduced ejection fraction (HFrEF) has resurfaced as a potential treatment goal. Inotropic therapy is now better understood through its underlying mechanism as opposed to the observed effect of increasing contractility. Calcitropes are a subgroup of inotropes that largely depend on the stimulation of adenylyl cyclase to transform ATP into cyclic adenosine monophosphate (cAMP). At least two clinically relevant calcitropes-istaroxime and probenecid-improve contractility through an increase in systolic intracellular calcium without activating cAMP production. Probenecid, which has been safely used clinically for decades in non-cardiac conditions, has recently been identified as an agonist of the transient receptor potential vanilloid 2 channel. Translational studies have shown that it improves calcium cycling and contractility without activating noxious pathways associated with cAMP-dependent calcitropes and can improve cardiac function in patients with HFrEF. METHODS: The Re-Prosper-HF study (Repurposing Probenecid for the Treatment of Heart Failure with Reduced Ejection Fraction) is a three-site double-blinded randomized-controlled trial that will test the hypothesis that probenecid can improve cardiac function in patients with HFrEF. Up to 120 patients will be randomized in this double-blind, placebo-controlled study that will assess whether oral probenecid administered at 1 g orally twice per day for 180 days in patients with NYHA II-III HFrEF improves systolic function (aim 1), functional status (aim 2), and self-reported health status (aim 3). DISCUSSION: Findings from this study will provide data informing its use for improving symptomatology in patients with HFrEF as well as exploratory data for outcomes such as hospital admission rates. TRIAL TEGISTRATION: The Re-Prosper HF Study (Re-Prosper HF) is registered on ClinicalTrials.gov with the identifier as NCT04551222. Registered on 9 September 2020.

US nursing home residents receiving PCV13 in the SNF by recorded pneumococcal vaccination up-to-date status, 2014-2018.

BACKGROUND: Since PCV13 was recommended in 2014, the characteristics of nursing home (NH) residents (and their facilities) recorded by facilities as not up-to-date with pneumococcal vaccination upon admission were unknown, and it is unknown if they received PCV13 in the NH. METHODS: We conducted a retrospective cohort of NH residents of Centers for Medicare and Medicaid (CMS)-certified skilled nursing facilities from October 1, 2014, through September 22, 2018. CMS' Minimum Data Set (MDS) was linked to Medicare Part B Carrier claims to corroborate pneumococcal vaccination up-to-date status in the MDS with pneumococcal vaccination claims. The primary outcome of interest was vaccination with PCV13 versus nonreceipt among those identified as "not up to date" according to facility MDS records. We estimated generalized estimating equation (GEE) models. RESULTS: Of the 1,459,814 residents recorded not up-to-date, (78.2%) had no Part B claims for PCV13 before or in the NH, the majority of whom (71.5%) were reported to have refused the vaccine when offered. Only 1.3% subsequently received PCV13 within 99 days after NH admission. In adjusted analyses, residents less likely to receive PCV13 in the NH than those who did included: residence in a for-profit facility (OR: 0.94 [95% CI: 0.89, 0.99]); male (OR: 0.92 [95% CI:0.89, 0.95]); black race (OR: 0.71 (95%CI: 0.66, 0.77); Hispanic ethnicity (OR: 0.69 [95%CI: 0.59, 0.75]); severely cognitively impaired compared with any lesser degree of impairment; had diabetes (OR: 0.93 [95%CI: 0.89, 0.97]); long-stay (≥100 days) compared with short-stay residents (OR: 0.17 (95%CI: 0.15, 0.20); and did not receive the influenza vaccine (OR: 0.74 (95%CI: 0.71, 0.77). CONCLUSIONS: Due to refusals, few NH residents recorded not up-to-date on pneumococcal vaccinations from 2014 to 2018 received PCV13 within three months of admission. Strategies to promote newly recommended PCV15 or PCV20 vaccination upon NH admission may be needed.

Evaluating the Findings of the IMPACT-C Randomized Clinical Trial to Improve COVID-19 Vaccine Coverage in Skilled Nursing Facilities.

IMPORTANCE: Identifying successful strategies to increase COVID-19 vaccination among skilled nursing facility (SNF) residents and staff is integral to preventing future outbreaks in a continually overwhelmed system. OBJECTIVE: To determine whether a multicomponent vaccine campaign would increase vaccine rates among SNF residents and staff. DESIGN, SETTING, AND PARTICIPANTS: This was a cluster randomized trial with a rapid timeline (December 2020-March 2021) coinciding with the Pharmacy Partnership Program (PPP). It included 133 SNFs in 4 health care systems across 16 states: 63 and 70 facilities in the intervention and control arms, respectively, and participants included 7496 long-stay residents (>100 days) and 17 963 staff. INTERVENTIONS: Multicomponent interventions were introduced at the facility level that included: (1) educational material and electronic messaging for staff; (2) town hall meetings with frontline staff (nurses, nurse aides, dietary, housekeeping); (3) messaging from community leaders; (4) gifts (eg, T-shirts) with socially concerned messaging; (5) use of a specialist to facilitate consent with residents' proxies; and (6) funds for additional COVID-19 testing of staff/residents. MAIN OUTCOMES AND MEASURES: The primary outcomes of this study were the proportion of residents (from electronic medical records) and staff (from facility logs) who received a COVID-19 vaccine (any), examined as 2 separate outcomes. Mixed-effects generalized linear models with a binomial distribution were used to compare outcomes between arms, using intent-to-treat approach. Race was examined as an effect modifier in the resident outcome model. RESULTS: Most facilities were for-profit (95; 71.4%), and 1973 (26.3%) of residents were Black. Among residents, 82.5% (95% CI, 81.2%-83.7%) were vaccinated in the intervention arm, compared with 79.8% (95% CI, 78.5%-81.0%) in the usual care arm (marginal difference 0.8%; 95% CI, -1.9% to 3.7%). Among staff, 49.5% (95% CI, 48.4%-50.6%) were vaccinated in the intervention arm, compared with 47.9% (95% CI, 46.9%-48.9%) in usual care arm (marginal difference: -0.4%; 95% CI, -4.2% to 3.1%). There was no association of race with the outcome among residents. CONCLUSIONS AND RELEVANCE: A multicomponent vaccine campaign did not have a significant effect on vaccination rates among SNF residents or staff. Among residents, vaccination rates were high. However, half the staff remained unvaccinated despite these efforts. Vaccination campaigns to target SNF staff will likely need to use additional approaches. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04732819.