Dataset Information

Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

ABSTRACT: Influenza severity increases and vaccine effectiveness decreases with age. High-dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care random assignment with HD (Fluzone® High-Dose) or SD (Fluzone®) influenza vaccine for their facility for the 2012-2013 influenza season. We used Minimum Data Set (MDS) 3.0 and Vital Status records for pre-specified clinical outcomes: 1) all-cause hospitalization, 2) NH mortality, and 3) functional decline. Intent-to-treat analyses were performed at the resident-level using Cox proportional hazards, multivariable Poisson, and logistic regression models accounting for clustering by facility. We randomized 39 NHs (19 SD and 20 HD), coordinated vaccine delivery, implemented web-based data collection, and accessed MDS data, demonstrating feasibility. There were 2,957 eligible residents (SD 1496; HD 1461); characteristics were similar between groups. A total of 301 (20.1%) of SD and 197 (13.5%) of HD allocated residents were ever hospitalized, (adjusted relative risk 0.680; 95% CI: 0.537, 0.862; p = 0.001). NH mortality was 274 (18.3%) SD vs. 249 (17.1%) HD, adjusted relative risk 0.834; 95% CI: 0.678, 1.027; p = 0.087). There were no differences in decline in functional status (13.4 vs. 13.8%, adjusted relative risk 0.994; 95% CI: 0.774,1.278; p = 0.965). We demonstrate that a pragmatic large-scale trial is feasible in a NH setting.

SUBMITTER: Gravenstein S

PROVIDER: S-EPMC5861801 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

Gravenstein Stefan S Davidson H Edward HE Han Lisa F LF Ogarek Jessica A JA Dahal Roshani R Gozalo Pedro L PL Taljaard Monica M Mor Vincent V

Human vaccines & immunotherapeutics 20171214 3

Influenza severity increases and vaccine effectiveness decreases with age. High-dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care ...[more]

PMID: 29090982

Similar Datasets

Project description:ObjectivesEstimates of influenza vaccine use are not available at the county level for U.S. nursing home (NH) residents but are critically necessary to guide the implementation of quality improvement programs aimed at increasing vaccination. Furthermore, estimates that account for differences in resident characteristics between counties are unavailable. We estimated risk-standardized vaccination rates (RSVRs) among short- and long-stay NH residents by U.S. county and identified drivers of geographic variation.MethodsWe conducted a retrospective cohort study utilizing 100% of 2013-2015 fee-for-service Medicare claims, Minimum Data Set assessments, Certification and Survey Provider Enhanced Reports, and Long-Term Care: Facts on Care in the U.S. We separately evaluated short-stay (<100 days) and long-stay (≥100 days) residents aged 65 and older across the 2013-2014 and 2014-2015 influenza seasons. We estimated RSVRs via hierarchical logistic regression adjusting for 32 resident-level covariates. We then used multivariable linear regression models to assess associations between county-level NHs predictors and RSVRs.ResultsThe study cohort consisted of 2,817,217 residents in 14,658 NHs across 2798 counties. Short-stay residents had lower RSVRs than long-stay residents (2013-2014: median [interquartile range], 69.6% [62.8-74.5] vs 84.0% [80.8-86.4]), and there was wide variation within each population (range, 11.4-89.8 vs 49.1-92.6). Several modifiable facility-level characteristics were associated with increased RSVRs, including higher registered nurse to total nurse ratio and higher total staffing for licensed practical nurses, speech-language pathologists, and social workers. Characteristics associated with lower RSVRs included higher percentage of residents restrained, with a pressure ulcer, and NH-level hospitalizations per resident-year.ConclusionsSubstantial county-level variation in influenza vaccine use exists among short- and long-stay NH residents. Quality improvement interventions to improve vaccination rates can leverage these results to target NHs located in counties with lower risk-standardized vaccine use.

Project description:Abstract Background Nursing home residents account for 45% SARS-CoV-2 related deaths in the U.S. but only 0.6% of the population. Our research group conducted a large pragmatic cluster randomized influenza vaccine trial in 965 nursing homes (NCT03965195). Due to the pandemic and its impact after the influenza season, we prospectively collected reports of SARS-CoV-2 outbreaks and performed a prospective study on the association between contract staffing and reported outbreaks of SARS-CoV-2. We hypothesized those using more contract nursing care would have higher risk of an outbreak. Methods From February through April, we collected monthly facility-level, self-reported data on SARS-CoV-2 outbreaks. Facility characteristics were taken from public data from Centers for Medicaid and Medicare services. Predictors of SARS-CoV-2 outbreaks were identified using a LASSO variable selection procedure, with a generalized linear, Poisson family model. Facility characteristics evaluated include demographics (e.g. number of residents), influenza vaccination rates, quality measures (e.g. % with UTI), and functional status (e.g. % with tube feedings). Facilities with contract staffing hours in the upper 25% quantile of direct care (RN, LPN, CNA) were considered ‘heavy use’. Results Of 965 randomized NHs, 663/965 (69%) reported data on SARS-CoV-2 outbreaks. On average, 13% of facilities had at least one outbreak, with 5/842 (0.5%) outbreaks in February, 91/835 (10.8%) in March and 217/686 (30%) in April. SARS-CoV-2 (+) facilities were larger (average total beds, 151 vs. 117), but were mostly similar by functional and cognitive status. Occupancy rate, total residents, Influenza vaccination rate, % with UTI, receiving respiratory treatments, tube feedings, and Medicaid payers were adjusted for in the analysis. The ‘heavy use’ of contract staffing included those with >223 hours per quarter. A multivariable regression found the relative risk SARS-CoV-2 outbreak was 1.56 (95% Confidence Interval: 1.22, 1.99) with heavy use of contract staffing. Conclusion The participating nursing homes in our vaccine trial with SARS-CoV-2 outbreaks were larger. Our study highlights that heavy use of contract staffing was associated with 56% increased risk of an outbreak. Disclosures Kevin McConeghy, Pharm.D., Pfizer (Grant/Research Support)Sanofi-Pasteur (Grant/Research Support)Seqirus Pharmaceuticals (Grant/Research Support) H. Edward Davidson, PharmD, MPH, Sanofi pasteur (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Seqirus (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support) Lisa Han, MPH, Sanofi Pasteur (Grant/Research Support)Seqirus (Grant/Research Support) David Canaday, M.D., Pfizer (Research Grant or Support)Sanofi Pasteur (Research Grant or Support)Seqirus (Advisor or Review Panel member, Research Grant or Support) Vincent Mor, Ph.D., naviHealth (Consultant)

Project description:BackgroundSince the 2008 inception of universal childhood influenza vaccination, national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent. Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70%.PurposeTo evaluate an intervention to increase childhood influenza vaccination across age and racial groups.MethodsIn 2011-2012, a total of 20 primary care practices treating children were randomly assigned to the intervention and control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine, in-service staff meetings, and publicity.ResultsThe average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm (n=10 practices) than the control arm (n=10 practices); for children aged 9-18 years (11.1 pct pts intervention vs 4.3 pct pts control, p<0.05); for non-white children (16.7 pct pts intervention vs 4.6 pct pts control, p<0.001); and overall (9.9 pct pts intervention vs 4.2 pct pts control, p<0.01). In multi-level modeling that accounted for person- and practice-level variables and the interactions among age, race, and intervention, the likelihood of vaccination increased with younger age group (6-23 months); white race; commercial insurance; the practice's pre-intervention vaccination rate; and being in the intervention arm. Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9-18 years.ConclusionsA multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups, especially in practices with large percentages of minority children.

Project description:BackgroundScholarly Concentrations programs in U.S. medical schools aim to instill passion for critical thinking and promote careers in academic medicine. The rise of these programs has seen variable goals, structure, and outcomes. Transformation of these programs internationally is in its infancy.MethodsWe describe implementation of the Johns Hopkins School of Medicine Scholarly Concentrations program, offering Basic Science, Clinical Science, Medical Ethics/Healing Arts, History of Medicine, and Public Health/Community Service, at Bezmiâlem Vakif University in Istanbul, Turkey. Over six modules in the preclinical years, students develop a faculty-mentored experience which encourages the acquisition of attitudes and skills for self-directed, lifelong learning and scholarship. This culminates in abstract and project presentation. We report program characteristics (context and logistics) and outcomes (student engagement and experiences).ResultsThe Scholarly Concentrations program at Bezmiâlem began in 2014, with nearly two completed cohorts of students. In comparison to Johns Hopkins, students at Bezmiâlem begin at an earlier age (thus do not have as much prior research experience) and are subsequently evaluated for residency in terms of test scores rather than scholarship and publications, but have a similar level of intellectual curiosity and desire to take ownership of their project. Eighty-two percent of Bezmiâlem students stated the project they pursued was either their own idea or was an idea they formed after meeting with their mentor. Students at Bezmialem were more likely to choose Clinical Science projects (p = 0.009). Only 5% of Bezmiâlem students in end-of-course survey felt dissatisfied with the level of ownership they experienced with their project, a frequency similar to that seen by Johns Hopkins students (2%).ConclusionsScholarly Concentrations programs play an important role in U.S. medical schools, and these programs can be successfully implemented internationally. The Scholarly Concentrations program at Johns Hopkins has been transformed to a program at Bezmiâlem in Istanbul, the first program outside North America or the European Union. When designing these programs, one must consider the context, logistics, student engagement, and outcomes. While long-term outcomes are needed, this can serve as a model for implementation elsewhere.

Dataset Information

Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

Publications

Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets