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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19, SARS-CoV Infection

Intervention / Treatment
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* Behavioral: Coaching, Cleaning, Communication, Collaboration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will have a cluster-randomized design in which two of the four nursing homes will be randomized to the intervention arm or the control arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Two facilities will follow their local protocols for infection prevention, including COVID-19 precautions. We will swab environmental surfaces at these sites to compare outcomes. | |
| Experimental: Intervention<br>Using a cluster-randomized design, we will test a multimodal aging-friendly intervention including four components (4Cs): Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise We hypothesize that the implementation of this organizational QI educational program will be associated with lower odds of SARS-CoV-2 transmission to the environment. | Behavioral: Coaching, Cleaning, Communication, Collaboration<br>* Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environmental Contamination, Nursing Home, Interventions