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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

More Details

NCT ID
NCT05270980
Status
Completed
Sponsor
NYU Langone Health

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.