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

NCT ID: NCT04933981

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1587 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-06-30

Brief Summary

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.

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.

Conditions

COVID-19 Respiratory Infection; SARS-CoV-2 Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Nasopharyngeal swab for SARS-CoV-2

Intervention Type: DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

City Council of Cologne, Department of Public Health, NRW, Germany

UNKNOWN

Sponsor Role: collaborator

City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany

UNKNOWN

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Oliver Cornely, MD

Professor, Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver A Cornely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34669164 (View on PubMed)

Other Identifiers

3S fuer Koeln

Identifier Type: -

Identifier Source: org_study_id