Incidence of Severe COVID-19 Illness Following Vaccination and Booster With BNT162b2, mRNA-1273, and Ad26.COV2.S Vaccines.

Importance: Evidence describing the incidence of severe COVID-19 illness following vaccination and booster with BNT162b2, mRNA-1273, and Ad26.COV2.S vaccines is needed, particularly for high-risk populations. Objective: To describe the incidence of severe COVID-19 illness among a cohort that received vaccination plus a booster vaccine dose. Design, Setting, and Participants: Retrospective cohort study of adults receiving care at Veterans Health Administration facilities across the US who received a vaccination series plus 1 booster against SARS-CoV-2, conducted from July 1, 2021, to May 30, 2022. Patients were eligible if they had received a primary care visit in the prior 2 years and had documented receipt of all US Food and Drug Administration-authorized doses of the initial mRNA vaccine or viral vector vaccination series after December 11, 2020, and a subsequent documented booster dose between July 1, 2021, and April 29, 2022. The analytic cohort consisted of 1 610 719 participants. Exposures: Receipt of any combination of mRNA-1273 (Moderna), BNT162b2 (Pfizer-BioNTech), and Ad26.COV2.S (Janssen/Johnson & Johnson) primary vaccination series and a booster dose. Main Outcomes and Measures: Outcomes were breakthrough COVID-19 (symptomatic infection), hospitalization with COVID-19 pneumonia and/or death, and hospitalization with severe COVID-19 pneumonia and/or death. A subgroup analysis of nonoverlapping populations included those aged 65 years or older, those with high-risk comorbid conditions, and those with immunocompromising conditions. Results: Of 1 610 719 participants, 1 100 280 (68.4%) were aged 65 years or older and 132 243 (8.2%) were female; 1 133 785 (70.4%) had high-risk comorbid conditions, 155 995 (9.6%) had immunocompromising conditions, and 1 467 879 (91.1%) received the same type of mRNA vaccine (initial series and booster). Over 24 weeks, 125.0 (95% CI, 123.3-126.8) per 10 000 persons had breakthrough COVID-19, 8.9 (95% CI, 8.5-9.4) per 10 000 persons were hospitalized with COVID-19 pneumonia or died, and 3.4 (95% CI, 3.1-3.7) per 10 000 persons were hospitalized with severe pneumonia or died. For high-risk populations, incidence of hospitalization with COVID-19 pneumonia or death was as follows: aged 65 years or older, 1.9 (95% CI, 1.4-2.6) per 10 000 persons; high-risk comorbid conditions, 6.7 (95% CI, 6.2-7.2) per 10 000 persons; and immunocompromising conditions, 39.6 (95% CI, 36.6-42.9) per 10 000 persons. Subgroup analyses of patients hospitalized with COVID-19 pneumonia or death by time after booster demonstrated similar incidence estimates among those aged 65 years or older and with high-risk comorbid conditions but not among those with immunocompromising conditions. Conclusions and Relevance: In a US cohort of patients receiving care at Veterans Health Administration facilities during a period of Delta and Omicron variant predominance, there was a low incidence of hospitalization with COVID-19 pneumonia or death following vaccination and booster with any of BNT162b2, mRNA-1273, or Ad26.COV2.S vaccines.

Association of Race and Ethnicity With Incidence of Dementia Among Older Adults.

Importance: The racial and ethnic diversity of the US, including among patients receiving their care at the Veterans Health Administration (VHA), is increasing. Dementia is a significant public health challenge and may have greater incidence among older adults from underrepresented racial and ethnic minority groups. Objective: To determine dementia incidence across 5 racial and ethnic groups and by US geographical region within a large, diverse, national cohort of older veterans who received care in the largest integrated health care system in the US. Design, Setting, and Participants: Retrospective cohort study within the VHA of a random sample (5% sample selected for each fiscal year) of 1 869 090 participants aged 55 years or older evaluated from October 1, 1999, to September 30, 2019 (the date of final follow-up). Exposures: Self-reported racial and ethnic data were obtained from the National Patient Care Database. US region was determined using Centers for Disease Control and Prevention (CDC) regions from residential zip codes. Main Outcomes and Measures: Incident diagnosis of dementia (9th and 10th editions of the International Classification of Diseases). Fine-Gray proportional hazards models were used to examine time to diagnosis, with age as the time scale and accounting for competing risk of death. Results: Among the 1 869 090 study participants (mean age, 69.4 [SD, 7.9] years; 42 870 women [2%]; 6865 American Indian or Alaska Native [0.4%], 9391 Asian [0.5%], 176 795 Black [9.5%], 20 663 Hispanic [1.0%], and 1 655 376 White [88.6%]), 13% received a diagnosis of dementia over a mean follow-up of 10.1 years. Age-adjusted incidence of dementia per 1000 person-years was 14.2 (95% CI, 13.3-15.1) for American Indian or Alaska Native participants, 12.4 (95% CI, 11.7-13.1) for Asian participants, 19.4 (95% CI, 19.2-19.6) for Black participants, 20.7 (95% CI, 20.1-21.3) for Hispanic participants, and 11.5 (95% CI, 11.4-11.6) for White participants. Compared with White participants, the fully adjusted hazard ratios were 1.05 (95% CI, 0.98-1.13) for American Indian or Alaska Native participants, 1.20 (95% CI, 1.13-1.28) for Asian participants, 1.54 (95% CI, 1.51-1.57) for Black participants, and 1.92 (95% CI, 1.82-2.02) for Hispanic participants. Across most US regions, age-adjusted dementia incidence rates were highest for Black and Hispanic participants, with rates similar among American Indian or Alaska Native, Asian, and White participants. Conclusions and Relevance: Among older adults who received care at VHA medical centers, there were significant differences in dementia incidence based on race and ethnicity. Further research is needed to understand the mechanisms responsible for these differences.

Comparative Effectiveness and Antibody Responses to Moderna and Pfizer-BioNTech COVID-19 Vaccines among Hospitalized Veterans - Five Veterans Affairs Medical Centers, United States, February 1-September 30, 2021.

The mRNA COVID-19 vaccines (Moderna and Pfizer-BioNTech) provide strong protection against severe COVID-19, including hospitalization, for at least several months after receipt of the second dose (1,2). However, studies examining immune responses and differences in protection against COVID-19-associated hospitalization in real-world settings, including by vaccine product, are limited. To understand how vaccine effectiveness (VE) might change with time, CDC and collaborators assessed the comparative effectiveness of Moderna and Pfizer-BioNTech vaccines in preventing COVID-19-associated hospitalization at two periods (14-119 days and ≥120 days) after receipt of the second vaccine dose among 1,896 U.S. veterans at five Veterans Affairs medical centers (VAMCs) during February 1-September 30, 2021. Among 234 U.S. veterans fully vaccinated with an mRNA COVID-19 vaccine and without evidence of current or prior SARS-CoV-2 infection, serum antibody levels (anti-spike immunoglobulin G [IgG] and anti-receptor binding domain [RBD] IgG) to SARS-CoV-2 were also compared. Adjusted VE 14-119 days following second Moderna vaccine dose was 89.6% (95% CI = 80.1%-94.5%) and after the second Pfizer-BioNTech dose was 86.0% (95% CI = 77.6%-91.3%); at ≥120 days VE was 86.1% (95% CI = 77.7%-91.3%) for Moderna and 75.1% (95% CI = 64.6%-82.4%) for Pfizer-BioNTech. Antibody levels were significantly higher among Moderna recipients than Pfizer-BioNTech recipients across all age groups and periods since vaccination; however, antibody levels among recipients of both products declined between 14-119 days and ≥120 days. These findings from a cohort of older, hospitalized veterans with high prevalences of underlying conditions suggest the importance of booster doses to help maintain long-term protection against severe COVID-19.†.

Burdens of post-acute sequelae of COVID-19 by severity of acute infection, demographics and health status.

The Post-Acute Sequelae of SARS-CoV-2 infection (PASC) have been characterized; however, the burden of PASC remains unknown. Here we used the healthcare databases of the US Department of Veterans Affairs to build a cohort of 181,384 people with COVID-19 and 4,397,509 non-infected controls and estimated that burden of PASC-defined as the presence of at least one sequela in excess of non-infected controls-was 73.43 (72.10, 74.72) per 1000 persons at 6 months. Burdens of individual sequelae varied by demographic groups (age, race, and sex) but were consistently higher in people with poorer baseline health and in those with more severe acute infection. In sum, the burden of PASC is substantial; PASC is non-monolithic with sequelae that are differentially expressed in various population groups. Collectively, our results may be useful in informing health systems capacity planning and care strategies of people with PASC.

Tele-Integrative Medicine to Support Rehabilitative Care.

Complementary and integrative health (CIH) modalities have therapeutic value in the multidisciplinary rehabilitation of chronic pain patients. Evidence of such has been seen with the Whole Health Model at the (Veterans Affairs) VA Healthcare system. CIH therapies, including yoga, tai chi, mindfulness meditation, hypnosis, self-massage, and acupressure, are significantly effective for managing chronic pain with little to no negative effects, and can be easily incorporated into telemedicine care with great potential benefit. The future of wellness in telemedicine is evolving with great potential, and needs further attention to addressing barriers of care.

SARS-CoV-2 Vaccine Effectiveness in a High-Risk National Population in a Real-World Setting.

BACKGROUND: With the emergency use authorization of multiple vaccines against SARS-CoV-2 infection, data are urgently needed to determine their effectiveness in a real-world setting. OBJECTIVE: To evaluate the short-term effectiveness of vaccines in preventing SARS-CoV-2 infection. DESIGN: Test-negative case-control study using conditional logistic regression. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: All veterans who had testing for SARS-CoV-2 infection between 15 December 2020 and 4 March 2021 and no confirmed infection before 15 December 2020. INTERVENTION: SARS-CoV-2 vaccination with either the BNT-162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine as part of routine clinical care. MEASUREMENTS: Effectiveness of vaccination against confirmed SARS-CoV-2 infection. RESULTS: Among 54 360 persons who tested positive and 54 360 propensity score-matched control participants, the median age was 61 years, 83.6% were male, and 62% were White. Median body mass index was 31 kg/m2 among those who tested positive and 30 kg/m2 among those who tested negative. Among those who tested positive, 9800 (18.0%) had been vaccinated; among those who tested negative, 17 825 (32.8%) had been vaccinated. Overall vaccine effectiveness 7 or more days after the second dose was 97.1% (95% CI, 96.6% to 97.5%). Effectiveness was 96.2% (CI, 95.5% to 96.9%) for the Pfizer-BioNTech BNT-162b2 vaccine and 98.2% (CI, 97.5% to 98.6%) for the Moderna mRNA-1273 vaccine. Effectiveness remained above 95% regardless of age group, sex, race, or presence of comorbidities. LIMITATIONS: Predominantly male population; lack of data on disease severity, mortality, and effectiveness by SARS-CoV-2 variants of concern; and short-term follow-up. CONCLUSION: Currently used vaccines against SARS-CoV-2 infection are highly effective in preventing confirmed infection in a high-risk population in a real-world setting. PRIMARY FUNDING SOURCE: None.

Association of Remdesivir Treatment With Survival and Length of Hospital Stay Among US Veterans Hospitalized With COVID-19.

Importance: Randomized clinical trials have yielded conflicting results about the effects of remdesivir therapy on survival and length of hospital stay among people with COVID-19. Objective: To examine associations between remdesivir treatment and survival and length of hospital stay among people hospitalized with COVID-19 in routine care settings. Design, Setting, and Participants: This retrospective cohort study used data from the Veterans Health Administration (VHA) to identify adult patients in 123 VHA hospitals who had a first hospitalization with laboratory-confirmed COVID-19 from May 1 to October 8, 2020. Propensity score matching of patients initiating remdesivir treatment to control patients who had not initiated remdesivir treatment by the same hospital day was used to create the analytic cohort. Exposures: Remdesivir treatment. Main Outcomes and Measures: Time to death within 30 days of remdesivir treatment initiation (or corresponding hospital day for matched control individuals) and time to hospital discharge with time to death as a competing event. Associations between remdesivir treatment and these outcomes were assessed using Cox proportional hazards regression in the matched cohort. Results: The initial cohort included 5898 patients admitted to 123 hospitals, 2374 (40.3%) of whom received remdesivir treatment (2238 men [94.3%]; mean [SD] age, 67.8 [12.8] years) and 3524 (59.7%) of whom never received remdesivir treatment (3302 men [93.7%]; mean [SD] age, 67.0 [14.4] years). After propensity score matching, the analysis included 1172 remdesivir recipients and 1172 controls, for a final matched cohort of 2344 individuals. Remdesivir recipients and matched controls were similar with regard to age (mean [SD], 66.6 [14.2] years vs 67.5 [14.1] years), sex (1101 men [93.9%] vs 1101 men [93.9%]), dexamethasone use (559 [47.7%] vs 559 [47.7%]), admission to the intensive care unit (242 [20.7%] vs 234 [19.1%]), and mechanical ventilation use (69 [5.9%] vs 45 [3.8%]). Standardized differences were less than 10% for all measures. Remdesivir treatment was not associated with 30-day mortality (143 remdesivir recipients [12.2%] vs 124 controls [10.6%]; log rank P = .26; adjusted hazard ratio [HR], 1.06; 95% CI, 0.83-1.36). Results were similar for people receiving vs not receiving dexamethasone at remdesivir initiation (dexamethasone recipients: adjusted HR, 0.93; 95% CI, 0.64-1.35; nonrecipients: adjusted HR, 1.19; 95% CI, 0.84-1.69). Remdesivir recipients had a longer median time to hospital discharge compared with matched controls (6 days [interquartile range, 4-12 days] vs 3 days [interquartile range, 1-7 days]; P < .001). Conclusions and Relevance: In this cohort study of US veterans hospitalized with COVID-19, remdesivir treatment was not associated with improved survival but was associated with longer hospital stays. Routine use of remdesivir may be associated with increased use of hospital beds while not being associated with improvements in survival.

Interorganizational Care Coordination of Rural Veterans by Veterans Affairs and Community Care Programs: A Systematic Review.

BACKGROUND: In the unique context of rural Veterans' health care needs, expansion of US Department of Veterans Affairs and Community Care programs under the MISSION Act, and the uncertainties of coronavirus disease 2019 (COVID-19), it is critical to understand what may support effective interorganizational care coordination for increased access to high-quality care. OBJECTIVES: We conducted a systematic review to examine the interorganizational care coordination initiatives that Veterans Affairs (VA) and community partners have pursued in caring for rural Veterans, including challenges and opportunities, organizational domains shaping care coordination, and among these, initiatives that improve or impede health care outcomes. RESEARCH DESIGN: We followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to search 2 electronic databases (PubMed and Embase) for peer-reviewed articles published between January 2009 and May 2020. Building on prior research, we conducted a systematic review. RESULTS: Sixteen articles met our criteria. Each captured a unique health care focus while examining common challenges. Four organizational domains emerged: policy and administration, culture, mechanisms, and relational practices. Exemplars highlight how initiatives improve or impede rural health care delivery. CONCLUSIONS: This is the first systematic review, to our knowledge, examining interorganizational care coordination of rural Veterans by VA and Community Care programs. Results provide exemplars of interorganizational care coordination domains and program effectiveness. It suggests that partners' efforts to align their coordination domains can improve health care, with rurality serving as a critical contextual factor. Findings are important for policies, practices, and research of VA and Community Care partners committed to improving access and health care for rural Veterans.

BMI and Risk for Severe COVID-19 Among Veterans Health Administration Patients.

OBJECTIVE: The purpose of this study was to assess associations between BMI and severe coronavirus disease 2019 (COVID-19) outcomes: hospitalization, intensive care unit (ICU) admission, and mortality. A secondary aim was to investigate whether associations varied by age. METHODS: The cohort comprised patients in the Veterans Health Administration (VHA) who tested positive for COVID-19 (N = 9,347). For each outcome, we fit piecewise logistic regression models with restricted cubic splines (knots at BMI of 23, 30, and 39), adjusting for age, sex, comorbidities, VHA nursing home residence, and race/ethnicity. Supplemental analyses included age-by-BMI interaction terms (α = 0.05). RESULTS: We found evidence of a nonlinear J-curve association between BMI and likelihood of hospitalization and mortality. BMI was associated with increased odds for hospitalization, ICU admission, and mortality among patients with BMI 30 to 39 but decreased odds of hospitalization and mortality for patients with BMI 23 to 30. Patients under age 75 with BMI between 30 and 39 had increased odds for mortality with increasing BMI. CONCLUSIONS: Odds for severe outcomes with COVID-19 infection increased with increasing BMI for people with, but not without, obesity. This nonlinear relationship should be tested in future research. COVID-19 public health messages in VHA, and broadly, should incorporate information about risks associated with all classes of obesity, particularly for those under age 75.

Converting a Geriatrics Clinic to Virtual Visits during COVID-19: A Case Study.

BACKGROUND: To characterize the experience of converting a geriatrics clinic to telehealth visits in early stages of a pandemic. DESIGN: An organizational case study with mixed methods evaluation from the first 8 weeks of converting a geriatrics clinic from in-person visits to video and telephone visits. SETTING: Veteran's Health Administration in Northern California Participants Community-dwelling older Veterans receiving care at VA Palo Alto Geriatrics clinic. Veterans had a mean age of 85.7 (SD = 6.8) and 72.1% had cognitive impairment. INTERVENTION: Veterans with face-to-face appointments were converted to video or telephone visits to mitigate exposure to community spread of COVID-19. MEASUREMENTS: Thirty-two patient evaluations and 80 clinician feedback evaluations were completed. This provided information on satisfaction, care access during pandemic, and travel and time savings. RESULTS: Of the 62 scheduled appointments, 43 virtual visits (69.4%) were conducted. Twenty-six (60.5%) visits were conducted via video, 17 (39.5%) by telephone. Virtual visits saved patients an average of 118.6 minutes each. Patients and providers had similar, positive perceptions about telehealth to in-person visit comparison, limiting exposure, and visit satisfaction. After the telehealth appointment, patients indicated greater comfort with using virtual visits in the future. Thirty-one evaluations included comments for qualitative analysis. We identified 3 main themes of technology set-up and usability, satisfaction with visit, and clinical assessment and communication. CONCLUSION: During a pandemic that has limited the ability to safely conduct inperson services, virtual formats offer a feasible and acceptable alternative for clinically-complex older patients. Despite potential barriers and additional effort required for telehealth visits, patients expressed willingness to utilize this format. Patients and providers reported high satisfaction, particularly with the ability to access care similar to in-person while staying safe. Investing in telehealth services during a pandemic ensures that vulnerable older patients can access care while maintaining social distancing, an important safety measure.

Respiratory co-infections with COVID-19 in the Veterans Health Administration, 2020.

Reporting of Coronavirus disease 2019 (COVID-19) co-infections with other respiratory pathogens has varied. We evaluated 825,280 molecular and/or viral culture respiratory assays within the Veterans Health Administration from September 29, 2019 to May 31, 2020. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detected in 10,222 of 174,746 (5.8%) individuals. 30,063 (17.2%) of 174,746 individuals tested for SARS-CoV-2 had additional respiratory pathogen testing; co-infection was identified in 56 of 3757 (1.5%) individuals positive for SARS-CoV-2. Among those negative for SARS-CoV-2, 1022 of 26,306 (3.9%) were positive for at least 1 respiratory pathogen. Compared to COVID-19 mono-infection, individuals with COVID-19 co-infection had lower odds of being female. Compared to non-COVID-19 respiratory pathogen infection, individuals with COVID-19 co-infection had lower odds of being female, were hospitalized more frequently, had higher odds of death, and were younger at death. Our findings suggest COVID-19 co-infections were rare; however, not all COVID-19 patients were concurrently tested for other respiratory pathogens and seasonal decreases in other respiratory pathogens were occurring as COVID-19 emerged.

Temperature Screening for SARS-CoV-2 in Nursing Homes: Evidence from Two National Cohorts.

BACKGROUND/OBJECTIVES: Infection screening tools classically define fever as 38.0°C (100.4°F). Frail older adults may not mount the same febrile response to systemic infection as younger or healthier individuals. We evaluate temperature trends among nursing home (NH) residents undergoing diagnostic SARS-CoV-2 testing and describe the diagnostic accuracy of temperature measurements for predicting test-confirmed SARS-CoV-2 infection. DESIGN: Retrospective cohort study evaluating diagnostic accuracy of pre-SARS-CoV-2 testing temperature changes. SETTING: Two separate NH cohorts tested diagnostically (e.g., for symptoms) for SARS-CoV-2. PARTICIPANTS Veterans residing in Veterans Affairs (VA) managed NHs and residents in a private national chain of community NHs. MEASUREMENTS: For both cohorts, we determined the sensitivity, specificity, and Youden's index with different temperature cutoffs for SARS-CoV-2 polymerase chain reaction results. RESULTS: The VA cohort consisted of 1,301 residents in 134 facilities from March 1, 2020, to May 14, 2020, with 25% confirmed for SARS-CoV-2. The community cohort included 3,368 residents spread across 282 facilities from February 18, 2020, to June 9, 2020, and 42% were confirmed for SARS-CoV-2. The VA cohort was younger, less White, and mostly male. A temperature testing threshold of 37.2°C has better sensitivity for SARS-CoV-2, 76% and 34% in the VA and community NH, respectively, versus 38.0°C with 43% and 12% sensitivity, respectively. CONCLUSION: A definition of 38.0°C for fever in NH screening tools should be lowered to improve predictive accuracy for SARS-CoV-2 infection. Stakeholders should carefully consider the impact of adopting lower testing thresholds on testing availability, cost, and burden on staff and residents. Temperatures alone have relatively low sensitivity/specificity, and we advocate any threshold be used as part of a screening tool, along with other signs and symptoms of infection.

Rapid Increase in Telemental Health Within the Department of Veterans Affairs During the COVID-19 Pandemic.

Background: The use of telemental health via videoconferencing (TMH-V) became critical during the Coronavirus disease 2019 (COVID-19) pandemic due to restriction of non-urgent in-person appointments. The current brief report demonstrates the rapid growth in TMH-V appointments in the weeks following the pandemic declaration within the Department of Veterans Affairs (VA), the largest healthcare system in the United States. Methods: COVID-19 changes in TMH-V appointments were captured during the six weeks following the World Health Organization's pandemic declaration (March 11, 2020-April 22, 2020). Pre-COVID-19 TMH-V encounters were assessed from October 1, 2017 to March 10, 2020. Results: Daily TMH-V encounters rose from 1,739 on March 11 to 11,406 on April 22 (556% growth, 222,349 total encounters). Between March 11-April 22, 114,714 patients were seen via TMH-V, and 77.5% were first-time TMH-V users. 12,342 MH providers completed a TMH-V appointment between March 11-April 22, and 34.7% were first-time TMH-V users. The percentage growth of TMH-V appointments was higher than the rise in telephone appointments (442% growth); in-person appointments dropped by 81% during this time period. Discussion and Conclusions: The speed of VA's growth in TMH-V appointments in the wake of the COVID-19 pandemic was facilitated by its pre-existing telehealth infrastructure, including earlier national efforts to increase the number of providers using TMH-V. Longstanding barriers to TMH-V implementation were lessened in the context of a pandemic, during which non-urgent in-person MH care was drastically reduced. Future work is necessary to understand the extent to which COVID-19 related changes in TMH-V use may permanently impact mental health care provision.