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

Sponsor
University of Michigan (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04739449
Collaborator
National Institute on Aging (NIA) (NIH)
0
Enrollment
2
Arms
2.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Coaching, Cleaning, Communication, Collaboration
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Health Services Research
Official Title:
'4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration
Anticipated Study Start Date :
Dec 4, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
No Intervention: 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.

Experimental: Intervention

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
Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Michigan
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lona Mody, Amanda Sanford Hickey Collegiate Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT04739449
Other Study ID Numbers:
  • HUM00186126
  • 3P30AG024824-16S1
First Posted:
Feb 4, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lona Mody, Amanda Sanford Hickey Collegiate Professor of Internal Medicine, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021