Benefit of Expanded Surveillance of Nursing Homes During the COVID-19 Pandemic

Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic

Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection; COVID-19 Respiratory Infection
• Intervention / Treatment: Diagnostic test: Nasopharyngeal swab for SARS-CoV-2

Detailed Description

Nursing homes for senior citizens are considered risk areas for the transmission of SARS-CoV-2. To protect these risk groups, different strategies have been implemented within the framework of legally applicable conditions. The aim of this study is to observe two procedural standards (e.g. visiting restrictions, hygiene measurements):

• On the one hand, a standard procedure without testing of visitors and employees and
• on the other hand, a standard procedure with additional surveillance by voluntary testing of visitors and staff for SARS-CoV-2 and associated relaxation of measures for contact of visitors with residents.

Both standard procedures are designed to ensure adequate protection against infection. The standard procedure with the use of relaxing the measures after testing aims to make the experience of social isolation more bearable for the residents of care facilities and thus less stressful from a psychological point of view. The extent of such possible effects is not the subject of the present study.

The primary aim of the study is to observe the number of SARS-CoV-2 infections among residents of nursing homes for senior citizens under different procedural standards for infection control.

In this study, various measures specified by care institutions for visits to senior citizens' homes are accompanied by scientific screening. The aim of the screening and the analysis of infection protection measures is to enable this vulnerable group to regain participation in society but still slow down the spread of the virus and prevent an outbreak.

The (mobile) infection control center ("Coronamobil") of the University Hospital of Cologne (UKK) makes a decisive contribution to the longitudinal investigation of a risk population and to the early detection of chains of infection in addition to the surveillance carried out by the authorities. In this study, the Coronamobil and personnel are provided to avoid an additional screening burden for the homes.

Surveillance of nursing homes allows protection of particularly vulnerable populations in the SARS-CoV-2 pandemic, and additional controlled contact. An evidence-based, safe and human visit concept could be transferred from Cologne to the whole of Germany. The resulting scientific knowledge would additionally provide a foundation for the control of future outbreak situations.

• Study Type: Observational
• Enrollment (Actual): 1587

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• One-time or frequent visitors in care facilities with standard 2 who want to be tested voluntarily
• employees in care facilities with standard 2 who want to be tested voluntarily
• Successful declaration of consent via the UHC Corona Web Tool

Description

Inclusion Criteria:

• One-time or frequent visitors in care facilities of the INH group who want to be tested for SARS-CoV-2 voluntarily
• employees (HCW) in care facilities of the INH group who want to be tested voluntarily
• Successful declaration of consent via the UKK Corona web tool

Exclusion Criteria:

• Visitors and employees in care facilities of the INH group with signs of SARS-CoV-2 infection
• No participants in the context of the study are in principle:
• one-time and frequent visitors in care facilities of the CNH group
• employees in care facilities of the CNH group
• Residents in care facilities of the CNH and the INH group

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
interventional nursing home (INH).; regular, twice to three times weekly, and voluntary, i.e. non-mandatory, on-site testing for SARS-CoV-2 of HCW and visitors (INH)	Diagnostic test: Nasopharyngeal swab for SARS-CoV-2; in the interventional group, regular, i.e. twice to three times weekly, SARS-CoV-2 testing was offered to health-care workers and visitors of nursing homes
control nursing home (CNH); routine setting without frequent regular testing for SARS-CoV-2 (control nursing homes; CNH). Testing only performed by local health authorities upon medical indication, i.e. non-surveillance testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection among residents	SARS-CoV-2 infection among residents in INH and CNH (proof of SARS-CoV-2 DNA on nasopharyngeal swab with or without symptoms of SARS-CoV-2 infection)	Oct 15th until Dec 18th, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection among visitors and health-care workers (HCW) of INH	proof of SARS-CoV-2 DNA (asymptomatic and symptomatic) on nasopharyngeal swab among visitors and HCW in INH	Oct 15th until Dec 18th, 2020
Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests	Ct values in RT-PCR samples of SARS-CoV-2 PCR	Oct 15th until Dec 18th, 2020
Overall mortality, COVID-19 related mortality, and excess mortality	Overall mortality, COVID-19 related mortality defined as death while infected with SARS-CoV-2, and excess mortality were assessed by comparing NH mortality data of the same period in the previous year.	up to two weeks after study completion

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: City Council of Cologne, Department of Public Health, NRW, Germany; City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany
• Investigators: Principal Investigator: Oliver A Cornely, MD, University of Cologne

Publications and helpful links

General Publications

• Stemler J, Kramer T, Dimitriou V, Wieland U, Schumacher S, Sprute R, Oberste M, Wiesmuller G, Rau H, Pieper S, Bethe U, Lehmann C, Hellmich M, Klein F, Langebartels G, Cornely OA. Mobile PCR-based surveillance for SARS-CoV-2 to reduce visiting restrictions in nursing homes during the COVID-19 pandemic: a pilot study. Infection. 2022 Jun;50(3):607-616. doi: 10.1007/s15010-021-01716-4. Epub 2021 Oct 20.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surveillance; COVID-19 pandemic; nursing homes; visiting restrictions during the COVID-19 pandemic
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 3S fuer Koeln

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be made available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No