COVID-19 Serologic Strategies for Skilled Nursing Facilities

Study Overview
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Brief Summary
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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: 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 To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.

Official Title
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COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)

Conditions
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COVID-19

Intervention / Treatment
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* Other: Cohorting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (Cohorting)<br> | Other: Cohorting<br>* 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.<br>|
| No Intervention: Control Group (No Cohorting)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New COVID-19 Detected Infections Among Residents |  | Up to Month 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New COVID-19 Detected Infections Among Staff |  | Up to Month 5 | 
| Number of Hospitalizations Over Time |  | Up to Month 5 |