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

NCT04739449 | Withdrawn

• 2 other identifiers: HUM001861263P30AG024824-16S1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SARS-CoV Infection; Covid19

Keywords

Environmental Contamination; Nursing Home; Interventions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

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.

Behavioral: Coaching, Cleaning, Communication, Collaboration

Interventions

Coaching, Cleaning, Communication, Collaboration BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not located in a participating nursing home facility
• \- Healthcare worker at a participating nursing home facility
• \- None

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amanda Sanford Hickey Collegiate Professor of Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 4, 2021
• Study Start: December 4, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share