COVID-19 Serologic Strategies for Skilled Nursing Facilities

NCT05270980 | Completed Results DMC

• 2 other identifiers: 20-012813U54AG063546-02S4
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of New COVID-19 Detected Infections Among Residents

  Up to Month 5

Secondary Outcomes (2)

• Number of New COVID-19 Detected Infections Among Staff

  Up to Month 5

• Number of Hospitalizations Over Time

  Up to Month 5

Study Arms (2)

Intervention Group (Cohorting)

EXPERIMENTAL

Other: Cohorting

Control Group (No Cohorting)

NO INTERVENTION

Interventions

Cohorting OTHER

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.

Intervention Group (Cohorting)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

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

Study Sites (2)

ArchCare at Mary Manning Walsh Home (MMW)

New York, New York, 10021, United States

Location

ArchCare at Terence Cardinal Cooke Health Care Center (TCC)

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Joshua Chodosh
• Organization: NYU Langone Health

Joshua.Chodosh@nyulangone.org

212-263-6768

Study Officials

• Joshua Chodosh, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 8, 2022
• Study Start: August 11, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: April 6, 2023
• Results First Posted: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (2)