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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04333862
Other study ID # 2020-00563
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2020
Est. completion date March 31, 2023

Study information

Verified date November 2023
Source Insel Gruppe AG, University Hospital Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. The main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.


Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and causes a pandemic of coronavirus disease 2019 (COVID-19, the disease caused by SARS-CoV-2). Protecting and supporting caregivers is essential to maintain the workforce in the hospital to treat patients. The use of recommended barrier precautions such as masks, gloves and gowns is of highest priority in the care of all patients with respiratory symptoms. However, given the long incubation period of 5 days there will be undiagnosed but infected patients with clinically mild cases, atypical presentations or even no symptoms at all. Thus, healthcare workers are on the one side at risk to get infected by asymptomatic patients and on the other side are critically needed for later phases of the epidemic, when the resources will in all likelihood be scarce or depleted. One potential strategy to maintain workforce throughout an epidemic is to reduce the workforce in the early phases. Reducing workforce at early phases might potentially reduce in-hospital infection of the caregivers and reduces early burnout. One way of reducing the active workforce is to postpone all elective and non-urgent medical interventions to later phases of the epidemic. Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. This new regulation took effect on March 16th 2020. Currently available resources to perform tests for SARS-CoV-2 infection are limited for the clinical routine and are therefore not available for research purposes. Thus, in the context of a clinical study the investigators aim to perform additional testing of SARS-CoV-2 of healthcare workers and patients in order to determine the clinical consequences of such desynchronization strategy, firstly within the current epidemic and secondly for future outbreaks. The main aim of present study is to determine if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.


Recruitment information / eligibility

Status Completed
Enrollment 519
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthcare workers of the Department for Visceral Surgery and Medicine - Patients of the Department for Visceral Surgery and Medicine - Written informed consent Exclusion Criteria: - No informed consent - Patients with known COVID-19 infection before hospitalization in the investigators' department

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Guido Beldi Bern

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fraction of healthcare workers infected with SARS-CoV-2 To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy 90 days
Secondary Fraction of healthcare workers with COVID-19 To compare the infection rate of hospitalized patients versus healthcare workers 90 days
Secondary Number of patients infected in the hospital Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired. 90 days
Secondary Development of SARS-CoV2 specific antibody repertoire To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection. 18 months
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