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

Not Applicable

Withdrawn

• Conditions: SARS-CoV Infection; Covid19
• Interventions: Behavioral: Coaching, Cleaning, Communication, Collaboration

• Registration Number: NCT04739449
• Lead Sponsor: University of Michigan

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19
• Study Start: 2021-12-04
• Primary Completion: 2022-02
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Coaching, Cleaning, Communication, Collaboration	Using a cluster-randomized design, we will test a multimodal aging-friendly intervention including four components (4Cs): 1. Coaching staff 2. Cleaning protocols, standardized 3. Communication with staff and leadership 4. 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.

Primary Outcome Measures

Name	Time	Method
Surface contamination with SARS-CoV-2	3 months, depending on COVID-19 epidemiology	Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms