N/A
N=87
COVID-19 Serologic Strategies for Skilled Nursing Facilities
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05270980 ↗Enrolled (actual)
87
Serious AEs
—
Results posted
Apr 2023
Primary outcome: Primary: Number of New COVID-19 Detected Infections Among Residents — 0; 0 Infections
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cohorting (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of New COVID-19 Detected Infections Among Residents |
0; 0 | — |
| SECONDARY Number of New COVID-19 Detected Infections Among Staff |
22; 12 | — |
| SECONDARY Number of Hospitalizations Over Time |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT05270980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.