COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)

COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Cohorting

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • ArchCare at Mary Manning Walsh Home (MMW)
    • New York, New York, United States, 10029
      • ArchCare at Terence Cardinal Cooke Health Care Center (TCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of New COVID-19 Detected Infections Among Residents	Up to Month 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of New COVID-19 Detected Infections Among Staff	Up to Month 5
Number of Hospitalizations Over Time	Up to Month 5

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Brown University; National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-01281; 3U54AG063546-02S4 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No