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

Primary Purpose

SARS-CoV Infection, Covid19

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coaching, Cleaning, Communication, Collaboration
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for SARS-CoV Infection focused on measuring Environmental Contamination, Nursing Home, Interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Surface contamination with SARS-CoV-2
    Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms

    Secondary Outcome Measures

    Full Information

    First Posted
    February 3, 2021
    Last Updated
    November 11, 2021
    Sponsor
    University of Michigan
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04739449
    Brief Title
    '4C' Intervention to Reduce SARS-CoV-2 (Covid-19) Transmission
    Official Title
    '4C' Intervention to Reduce SARS-CoV-2 Transmission: Coaching, Cleaning, Communication and Collaboration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Since the vaccine there are no COVID 19 cases in proposed study sites.
    Study Start Date
    December 4, 2021 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV Infection, Covid19
    Keywords
    Environmental Contamination, Nursing Home, Interventions

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Coaching, Cleaning, Communication, Collaboration
    Intervention Description
    Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise
    Primary Outcome Measure Information:
    Title
    Surface contamination with SARS-CoV-2
    Description
    Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms
    Time Frame
    3 months, depending on COVID-19 epidemiology

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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