Clinical trial NCT05270980: COVID-19 Serologic Strategies for Skilled Nursing Facilities
Official title: COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute on Aging (NIA)
First posted: 2022-03-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of New COVID-19 Detected Infections Among Residents
timeFrame: Up to Month 5
Secondary outcomes:
measure: Number of New COVID-19 Detected Infections Among Staff
timeFrame: Up to Month 5
measure: Number of Hospitalizations Over Time
timeFrame: Up to Month 5
Other outcomes:
Locations:
city: New York
country: United States
facility: ArchCare at Mary Manning Walsh Home (MMW)
state: New York
city: New York
country: United States
facility: ArchCare at Terence Cardinal Cooke Health Care Center (TCC)
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh, MD
role: PRINCIPAL_INVESTIGATOR
References: