COVID-19
Conditions
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.
Interventions
OTHERCohorting
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.
Sponsors
Brown University
National Institute on Aging (NIA)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of New COVID-19 Detected Infections Among Residents | Up to Month 5 |
Secondary
| Measure | Time frame |
|---|---|
| Number of New COVID-19 Detected Infections Among Staff | Up to Month 5 |
| Number of Hospitalizations Over Time | Up to Month 5 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (Cohorting) - Residents 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. This arm comprises residents of SNFs assigned to a cohorting strategy. | 14 |
| Control Group (No Cohorting) - Residents Residents at SNFs where no cohorting strategy has been assigned. | 2 |
| Intervention Group (Cohorting) - Staff Staff at SNFs where the cohorting strategy has been assigned. | 50 |
| Control Group (No Cohorting) - Staff Staff at control SNFs where no cohorting strategy has been assigned. | 21 |
| Total | 87 |
Baseline characteristics
| Characteristic | Intervention Group (Cohorting) - Residents | Total | Control Group (No Cohorting) - Staff | Intervention Group (Cohorting) - Staff | Control Group (No Cohorting) - Residents |
|---|---|---|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 13 | 60.25 years STANDARD_DEVIATION 15.25 | 52 years STANDARD_DEVIATION 8 | 55 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 30 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 0 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 80 Participants | 21 Participants | 46 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 66 Participants | 17 Participants | 44 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 10 Participants | 2 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 14 participants | 87 participants | 21 participants | 50 participants | 2 participants |
| Sex: Female, Male Female | 7 Participants | 70 Participants | 19 Participants | 43 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 2 Participants | 7 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of New COVID-19 Detected Infections Among Residents
Time frame: Up to Month 5
Population: A HIPAA waiver was granted to obtain vaccination and PCR data from all residents in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all residents of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 207 residents in Intervention units and 207 residents in Control units.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (Cohorting) - Residents | Number of New COVID-19 Detected Infections Among Residents | 0 Infections |
| Control Group (No Cohorting) - Residents | Number of New COVID-19 Detected Infections Among Residents | 0 Infections |
Secondary
Number of Hospitalizations Over Time
Time frame: Up to Month 5
Population: A HIPAA waiver was granted to obtain vaccination and PCR data for all residents in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all residents of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 207 residents in Intervention units and 207 residents in Control units.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (Cohorting) - Residents | Number of Hospitalizations Over Time | 0 Hospitalizations |
| Control Group (No Cohorting) - Residents | Number of Hospitalizations Over Time | 0 Hospitalizations |
Secondary
Number of New COVID-19 Detected Infections Among Staff
Time frame: Up to Month 5
Population: A HIPAA waiver was granted to obtain vaccination and PCR data for all staff in study units, not all of whom were participants. The overall number of participants analyzed for this outcome measure represent all staff of the SNFs for whom vaccination and PCR data were available. Therefore, the number of participants analyzed differs from the number of participants who completed the trial. Data were available for 89 staff in Intervention units and 88 staff in Control units.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (Cohorting) - Residents | Number of New COVID-19 Detected Infections Among Staff | 22 Infections |
| Control Group (No Cohorting) - Residents | Number of New COVID-19 Detected Infections Among Staff | 12 Infections |