View clinical trials related to Healthcare Worker.
Filter by:During critical personal protective equipment (PPE) shortages, such as those associated with the COVID-19 pandemic, Centers for Disease Control (CDC) recommends N95 extended use (wearing the same N95 for multiple patient encounters) and limited reuse (storing an N95 between shifts for use over multiple shifts with or without decontamination) as contingency and crisis capacity strategies, respectively. Many healthcare workers (HCWs) are employing these strategies out of necessity. The sustained performance of these respirators depends on the respirator maintaining its filtration efficiency and its ability to provide an adequate seal (fit) to the user's face. Fit testing is performed when a respirator is issued to the user and on an annual basis thereafter. A user-seal check is then performed whenever a respirator is donned. Previous studies have found repeated donnings/doffings to significantly decrease the respirator's fit. A recent pilot cross-sectional clinical study conducted by the University of California, San Francisco found fit failures of respirators after being worn for 2 shifts. However, more definitive data regarding respirator performance during reuse and extended use are lacking. The investigators plan to address these critical gaps in knowledge by conducting a prospective cohort study to determine the incidence of N95 fit failure when subjected to extended use/reuse in a clinical setting. The investigators plan to enroll 396 ED providers (including physicians, nurses, and staff) when obtaining a new NIOSH approved N95s and performing serial fit tests at the end of each 8-12 hour shift for up to 5 clinical shifts or until N95 failure, whichever is earlier. By carefully measuring fit test failure in a clinical setting, the investigators will be able to provide guidance regarding the safety of N95 extended use and reuse necessitated by the need for PPE conservation. Specifically, the investigators will address the following research questions: 1) how long N95s maintain their fit during extended use, 2) how many times N95s can be donned/doffed and maintain their fit, 3) the ability of a user seal check to indicate fit in the field, 4) what adverse health effects, reports of discomfort, or symptoms are experienced by users during extended use and reuse, 5) what effect does extended use and reuse have on N95 filtration performance, 6) the level of contamination of N95s when subjected to extended use and reuse, 7) the effect of modifications to N95 (covering an N95 with a face shield or surgical N95s, facial coverings) on fit failure.
Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. It is important to gather data with respect to this to further understand the prevalence of asymptomatic carriage in individuals who work in research facilities, offices and clinical areas of hospitals and research facilities/institutes since this has important implications for infection control, as well as staff and patient safety. The purpose of this study is to test whether a proportion of these individuals may be asymptomatic shedders of the COVID-19 virus.
The COVID-19 outbreak is having an impact on the well-being of healthcare workers. Previous reports on pandemics show that such an impact may last beyond the time of the outbreak. Mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. This single-arm trial explores the acceptability, safety and usefulness of an on-site, brief Mindfulness-based intervention to reduce stress for front line health workers during a crisis.
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
Background: Aim: To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design, participants and interventions: Prospective, randomized, parallel group, double-blinded, placebo controlled, study. including 440 participants who will be randomised to 2 treatment arms: hydroxychloroquine or placebo. Outcome variables: symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR, viral load during SARS-CoV-2 infection, seroconversion during the study period, incidence of any acute respiratory infection, days of sick leave. Statistical considerations: No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers. Thus, sample size calculations in the proposed trial are based on the investigators' best estimates for several parameters. In accordance to the effect of oseltamivir against symptomatic influenza, we assumed an approximate effectiveness of approximately 60% (HR of 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) as realistic. As a prophylactic intervention with HCQ, which may have side effects and for which supply shortage can be expected, was judged justifiable only if its effectiveness is high, we based our sample size consideration on a HR of 0.3. To estimate the probability of an event in both the experimental and the control group, very little data is available. In a Dutch point-prevalence study 0-10% of health-care workers were infected depending on the healthcare institution, depending on the hospital. This point-prevalence study was performed between 6 and 9 March, when the reported number of cases in the Netherlands was 33 and 77, respectively, according to the RIVM (https://www.rivm.nl/nieuws/resultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus). Additionally, in an a report published in the Lancet, 20% of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-2003 30191539568.html). As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. PCR positivity) probability of 10% in the control group and 3% in the experimental arm after the maximum study period. In summary, a sample size of 210 participants per arm is necessary to detect a HR of 0.3 with a power of 80.3% with an alpha-error of 0.05. To account for drop-outs and asymptomatic, undetected infection at inclusion or past infection with existing immunity, an additional 10 participants will randomized per treatment arm. The overall study population is therefore 440 participants. Statistical analysis will be based on two populations: A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline. And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80% of all doses of study medication.