COVID-19 Serologic Strategies for Skilled Nursing Facilities

NCT ID: NCT05270980

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2022-02-04

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group (Cohorting)

Group Type: EXPERIMENTAL

Cohorting

Intervention Type: 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.

Control Group (No Cohorting)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Chodosh, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

ArchCare at Mary Manning Walsh Home (MMW)

New York, New York, United States

ArchCare at Terence Cardinal Cooke Health Care Center (TCC)

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3U54AG063546-02S4

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-01281

Identifier Type: -

Identifier Source: org_study_id