Back to resultsCOVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cohorting
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria for Staff Stakeholders:
- Must be employees of ArchCare
- Must be members of included unit staff or those that float on those designated units
- Willing to participate in focus groups or semi-structured interviews with study team
Inclusion Criteria for Family Participants:
- Family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Family member of resident who is on designated study unit or eligible to be transferred to such unit
- Willing to participate in focus groups or semi-structured interviews with study team
Inclusion Criteria for Resident Participants:
- Resident has ability to communicate and follow simple commands
- Resident has ability to communicate and follow simple commands
- English- or Spanish-speaking
- Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
- Must agree to have serologic testing for COVID-19
- Agrees to remain on one of the facility units of study or to be transferred to such unit
Exclusion Criteria for Staff Stakeholders:
- Not employees of ArchCare
- Not members of included unit staff or those that float on those designated units
- Not willing to participate in focus groups or semi-structured interviews with study team
Exclusion Criteria for Family Participants:
- Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
- Not family member of resident who is on designated study unit or eligible to be transferred to such unit
- Not willing to participate in focus groups or semi-structured interviews with study team
Exclusion Criteria for Resident Participants:
- Resident is not living in the unit of intervention
- Resident does not have ability to communicate and follow simple commands
- Not English- or Spanish-speaking
- Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.
- If resident lacks capacity, that resident does not assent with surrogate who provides assent
- Does not agree to have serologic testing for COVID-19
- Refuses to agree to remain on one of the facility units of study or to be transferred to such unit
Sites / Locations
- ArchCare at Mary Manning Walsh Home (MMW)
- ArchCare at Terence Cardinal Cooke Health Care Center (TCC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group (Cohorting)
Control Group (No Cohorting)
Arm Description
Outcomes
Primary Outcome Measures
Number of New COVID-19 Detected Infections Among Residents
Secondary Outcome Measures
Number of New COVID-19 Detected Infections Among Staff
Number of Hospitalizations Over Time
Full Information
NCT ID
NCT05270980
First Posted
March 7, 2022
Last Updated
March 9, 2023
Sponsor
NYU Langone Health
Collaborators
Brown University, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05270980
Brief Title
COVID-19 Serologic Strategies for Skilled Nursing Facilities
Acronym
CERO
Official Title
COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Brown University, 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
Yes
5. Study Description
Brief Summary
The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:
To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible
To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (Cohorting)
Arm Type
Experimental
Arm Title
Control Group (No Cohorting)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cohorting
Intervention Description
The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure.
Primary Outcome Measure Information:
Title
Number of New COVID-19 Detected Infections Among Residents
Time Frame
Up to Month 5
Secondary Outcome Measure Information:
Title
Number of New COVID-19 Detected Infections Among Staff
Time Frame
Up to Month 5
Title
Number of Hospitalizations Over Time
Time Frame
Up to Month 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Staff Stakeholders:
Must be employees of ArchCare
Must be members of included unit staff or those that float on those designated units
Willing to participate in focus groups or semi-structured interviews with study team
Inclusion Criteria for Family Participants:
Family members of residents who reside at either TCC or MMW (ArchCare facilities)
Family member of resident who is on designated study unit or eligible to be transferred to such unit
Willing to participate in focus groups or semi-structured interviews with study team
Inclusion Criteria for Resident Participants:
Resident has ability to communicate and follow simple commands
Resident has ability to communicate and follow simple commands
English- or Spanish-speaking
Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
Must agree to have serologic testing for COVID-19
Agrees to remain on one of the facility units of study or to be transferred to such unit
Exclusion Criteria for Staff Stakeholders:
Not employees of ArchCare
Not members of included unit staff or those that float on those designated units
Not willing to participate in focus groups or semi-structured interviews with study team
Exclusion Criteria for Family Participants:
Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
Not family member of resident who is on designated study unit or eligible to be transferred to such unit
Not willing to participate in focus groups or semi-structured interviews with study team
Exclusion Criteria for Resident Participants:
Resident is not living in the unit of intervention
Resident does not have ability to communicate and follow simple commands
Not English- or Spanish-speaking
Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.
If resident lacks capacity, that resident does not assent with surrogate who provides assent
Does not agree to have serologic testing for COVID-19
Refuses to agree to remain on one of the facility units of study or to be transferred to such unit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ArchCare at Mary Manning Walsh Home (MMW)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
ArchCare at Terence Cardinal Cooke Health Care Center (TCC)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Joshua.Chodosh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
COVID-19 Serologic Strategies for Skilled Nursing Facilities
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