'4C' Intervention to Reduce SARS-CoV-2 (Covid-19) Transmission

Covid19 Clinical Trial

Official title:

'4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04739449
• Other study ID #: HUM00186126
• Secondary ID: 3P30AG024824-16S
• Status: Withdrawn
• Phase: N/A
• Start date: December 4, 2021
• Est. completion date: March 2022

Study information

• Verified date: November 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact.

This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.

Description:

In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for nursing home patients:

• 18 years of age or older

• Residing in a participating nursing home facility

• Active or recent (last 14 days) COVID-19 infection

Exclusion criteria for nursing home patients:

• Not located in a participating nursing home facility

Inclusion criteria for healthcare workers:

• Healthcare worker at a participating nursing home facility

Exclusion criteria for healthcare workers:

• None

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Behavioral:
• Coaching, Cleaning, Communication, Collaboration
Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface contamination with SARS-CoV-2	Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms	3 months, depending on COVID-19 epidemiology