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

NCT ID: NCT04739449

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-04

Study Completion Date

2022-03-31

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.

Conditions

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SARS-CoV Infection Covid19

Keywords

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Environmental Contamination Nursing Home Interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type EXPERIMENTAL

Coaching, Cleaning, Communication, Collaboration

Intervention Type BEHAVIORAL

1. Coaching staff
2. Cleaning protocols, standardized
3. Communication with staff and leadership
4. Collaboration with local expertise

Interventions

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Coaching, Cleaning, Communication, Collaboration

1. Coaching staff
2. Cleaning protocols, standardized
3. Communication with staff and leadership
4. Collaboration with local expertise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Residing in a participating nursing home facility
* Active or recent (last 14 days) COVID-19 infection


\- Healthcare worker at a participating nursing home facility

Exclusion Criteria

* Not located in a participating nursing home facility


\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Lona Mody

Amanda Sanford Hickey Collegiate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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3P30AG024824-16S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00186126

Identifier Type: -

Identifier Source: org_study_id