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

University of Michigan

Status: Withdrawn

Conditions: SARS-CoV Infection; Covid19

Treatments: Behavioral: Coaching, Cleaning, Communication, Collaboration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04739449

3P30AG024824-16S1 (U.S. NIH Grant/Contract)

HUM00186126

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Coaching, Cleaning, Communication, Collaboration