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CERO: COVID-19 Serologic Strategies for Skilled Nursing Facilities

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT05270980
Collaborator
Brown University (Other), National Institute on Aging (NIA) (NIH)
87
Enrollment
2
Locations
2
Arms
5.6
Actual Duration (Months)
43.5
Patients Per Site
7.8
Patients Per Site Per Month

Study Details

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:

  1. 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

  2. To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.

Condition or Disease Intervention/Treatment Phase
  • Other: Cohorting
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
Actual Study Start Date :
Aug 11, 2021
Actual Primary Completion Date :
Jan 27, 2022
Actual Study Completion Date :
Jan 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group (Cohorting)

Other: Cohorting
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.
No Intervention: Control Group (No Cohorting)

Outcome Measures

Primary Outcome Measures

  1. Number of New COVID-19 Detected Infections (Residents) Over Time [Month 12]

Secondary Outcome Measures

  1. Number of New COVID-19 Detected Infections (Staff) Over Time [Month 12]

  2. Number of Hospitalizations Over Time [Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ArchCare at Mary Manning Walsh Home (MMW) New York New York United States 10021
2 ArchCare at Terence Cardinal Cooke Health Care Center (TCC) New York New York United States 10029

Sponsors and Collaborators

  • NYU Langone Health
  • Brown University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Joshua Chodosh, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05270980
Other Study ID Numbers:
  • 20-01281
  • 3U54AG063546-02S4
First Posted:
Mar 8, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 25, 2022