Development of MDS-Based Predication Model for COPD Severity in Nursing Home Residents.

BACKGROUND: Assessing chronic obstructive pulmonary disease (COPD) severity is challenging in nursing home (NH) residents due to incomplete symptom assessments and exacerbation history. OBJECTIVE: The objective of this study was to predict COPD severity in NH residents using the Minimum Data Set (MDS), a clinical assessment of functional capabilities and health needs. METHODS: A cohort analysis of prospectively collected longitudinal data was conducted. Residents from geographically varied Medicare-certified NHs with age ≥60 years, COPD diagnosis, and ≥6 months NH residence at enrollment were included. Residents with severe cognitive impairment were excluded. Demographic characteristics, medical history, and MDS variables were extracted from medical records. The care provider-completed COPD Assessment Test (CAT) and COPD exacerbation history were used to categorize residents by Global Initiative for Chronic Lung Disease (GOLD) A to D groups. Multivariate multinomial logit models mapped the MDS to GOLD A to D groups with stepwise selection of variables. RESULTS: Nursing home residents (N = 175) were 64% women and had a mean age of 77.9 years. Among residents, GOLD B was most common (A = 13.1%; B = 44.0%; C = 5.7%; D = 37.1%). Any long-acting bronchodilator (LABD) use and any dyspnea were significant predictors of GOLD A to D groups. The predicted MDS-GOLD group (A = 6.9%; B = 52.6%; C = 4.6%; D = 36.0%) showed good model fit (correctly predicted = 60.6%). Nursing home residents may underuse group-recommended LABD treatment (no LABD: B = 53.2%; C = 80.0%; D = 40.0%). CONCLUSION AND RELEVANCE: The MDS, completed routinely for US NH residents, could potentially be used to estimate COPD severity. Predicted COPD severity with additional validation could provide a map to evidence-based treatment guidelines and may help to individualize treatment pathways for NH residents.

Cluster-randomized Trial of Adjuvanted Versus Nonadjuvanted Trivalent Influenza Vaccine in 823 US Nursing Homes.

BACKGROUND: Influenza leads in preventable infection-related hospitalization in nursing home (NH) residents. The adjuvanted trivalent influenza vaccine (aTIV) is more immunogenic than similarly dosed nonadjuvanted trivalent influenza vaccine (TIV), and observational studies suggest aTIV better prevents hospitalizations in older adults. We prospectively tested this in an NH setting. METHODS: NHs with ≥50 long-stay residents aged ≥65 years were randomized to offer aTIV or TIV for residents for the 2016-2017 influenza season. Using intent-to-treat resident-level analysis with Cox proportional hazards regression models adjusted for clustering by facility and a priori baseline covariates (eg, age, heart failure, and facility-level characteristics), we assessed relative aTIV:TIV effectiveness for hospitalization (ie, all-cause, respiratory, and pneumonia and influenza [P&I]). RESULTS: We randomized 823 NHs, housing 50 012 eligible residents, to aTIV or TIV. Residents were similar between groups by age (mean, ~79 years), heart failure, lung disease, and influenza and pneumococcal vaccine uptake, except aTIV homes housed fewer Black residents (14.5 vs 18.9%). Staff vaccine uptake was similar (~55%). P&I and all-cause resident hospitalization rates were lower (adjusted HR [aHR], .80 [95% CI, .66-.98; P = .03] and .94 [.89-.99; P = .02], respectively) for aTIV versus TIV, while the respiratory hospitalization rate was similar, in a season where vaccine effectiveness was considered poor. CONCLUSIONS: aTIV was more effective than TIV in preventing all-cause and P&I hospitalization from NHs during an A/H3N2-predominant season when TIV was relatively ineffective. CLINICAL TRIALS REGISTRATION: NCT02882100.

Adjuvanted Influenza Vaccine and Influenza Outbreaks in US Nursing Homes: Results From a Pragmatic Cluster-Randomized Clinical Trial.

BACKGROUND: Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). We report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks. METHODS: We evaluated the impact of the intent-to-treat vaccine assignment on outbreaks reported from November 2016 to March 2017. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case and adjusted for facility-level vaccination rates and resident characteristics in nursing homes. RESULTS: Of 823 randomized nursing homes, 777 (aTIV, n = 387; TIV, n = 390) reported information on influenza outbreaks. Treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% vs 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities, respectively; of these, 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio, .83; 95% confidence interval, .65-1.05) and laboratory-confirmed (.83; .63-1.06) influenza outbreaks. Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (.79; .61-.99) and 22% for laboratory-confirmed outbreaks (.78; .60-1.02). CONCLUSIONS: In an exploratory analysis of a cluster-randomized trial we observed 17-21% fewer outbreaks with aTIV than TIV. Clinical Trials Registration. (NCT02882100).

A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale.

BACKGROUND: Influenza, the most important viral infection affecting older adults, produces a substantial burden in health care costs, morbidity, and mortality. Influenza vaccination remains the mainstay in prevention and is associated with reduced rates of hospitalization, stroke, heart attack, and death in non-institutional older adult populations. Influenza vaccination produces considerably lower antibody response in the elderly compared to young adults. Four-fold higher vaccine antigen (high-dose) than in the standard adult vaccine (standard-dose) elicits higher serum antibody levels and antibody response in ambulatory elderly. PURPOSE: To describe the design considerations of a large clinical trial of high-dose compared to standard-dose influenza vaccine in nursing homes and baseline characteristics of participating nursing homes and long-stay (more than 90 days) residents over 65 years of age. METHODS: The high-dose influenza vaccine intervention trial is multifacility, cluster randomized controlled trial with a 2×2 factorial design that compares hospitalization rates, mortality, and functional decline among long-stay nursing home residents in facilities randomized to receive high-dose versus standard-dose influenza vaccine and also randomized with or without free staff vaccines provided by study organizers. Enrollment focused on nursing homes with a large long-stay resident population over 65 years of age. The primary outcome is the resident-level incidence of hospitalization with a primary diagnosis of pulmonary and influenza-like illness, based upon Medicare inpatient hospitalization claims. Secondary outcomes are all-cause mortality based upon the vital status indicator in the Medicare Vital Status file, all-cause hospitalization directly from the nursing home Minimum Data Set discharge records, and the probability of declining at least 4 points on the 28-point Activities of Daily Living Scale. RESULTS: Between February and September 2013, the high-dose influenza vaccine trial recruited and randomized 823 nursing homes. The analysis sample includes 53,035 long-stay nursing home residents over 65 years of age, representing 57.7% of the participating facilities' population. Residents are mainly women (72.2%), white (75.5%), with a mean age of 83 years. Common conditions include hypertension (79.2%), depression (55.1%), and diabetes mellitus (34.4%). The prevalence of circulatory and pulmonary disorders includes heart failure (20.5%), stroke (20.1%), and asthma/chronic obstructive pulmonary disease (20.2%). CONCLUSIONS: This high-dose influenza vaccine trial uniquely offers a paradigm for future studies of clinical and programmatic interventions within the framework of efforts designed to test the impact of changes in usual treatment practices adopted by health care systems. TRIAL REGISTRATION: NCT01815268.