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| ID | Type | Description | Link |
|---|---|---|---|
| 3U54AG063546-02S4 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institute on Aging (NIA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Cohorting) | Experimental |
| |
| Control Group (No Cohorting) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohorting | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of New COVID-19 Detected Infections Among Residents | Up to Month 5 |
| 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 |
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Inclusion Criteria for Staff Stakeholders:
Inclusion Criteria for Family Participants:
Inclusion Criteria for Resident Participants:
Exclusion Criteria for Staff Stakeholders:
Exclusion Criteria for Family Participants:
Exclusion Criteria for Resident Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Chodosh, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ArchCare at Mary Manning Walsh Home (MMW) | New York | New York | 10021 | United States | ||
| ArchCare at Terence Cardinal Cooke Health Care Center (TCC) |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Joshua.Chodosh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group (No Cohorting) - Residents | Residents at SNFs where no cohorting has been assigned. |
| FG002 | Intervention Group (Cohorting) - Staff | Staff at SNFs where the cohorting strategy has been assigned. |
| FG003 | Control Group (No Cohorting) - Staff | Staff at control SNFs where no cohorting strategy has been assigned. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The "Intervention Group (Cohorting) - Residents" and "Control Group (No Cohorting) - Residents" arms comprise residents at SNFs. The "Intervention Group (Cohorting) - Staff" and "Control Group (No Cohorting) - Staff" comprise staff at corresponding SNFs.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of New COVID-19 Detected Infections Among Residents | 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. | Posted | Number | Infections | Up to Month 5 |
|
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Deaths, serious adverse events, and non-serious adverse events were not assessed in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Chodosh | NYU Langone Health | 212-263-6768 | Joshua.Chodosh@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2021 | Feb 7, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2021 | Feb 7, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015331 | Cohort Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| New York |
| New York |
| 10029 |
| United States |
| BG001 | Control Group (No Cohorting) - Residents | Residents at SNFs where no cohorting strategy has been assigned. |
| BG002 | Intervention Group (Cohorting) - Staff | Staff at SNFs where the cohorting strategy has been assigned. |
| BG003 | Control Group (No Cohorting) - Staff | Staff at control SNFs where no cohorting strategy has been assigned. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group (No Cohorting) - Residents | Residents of SNFs where no cohorting strategy was assigned. |
|
|
| Secondary | Number of New COVID-19 Detected Infections Among Staff | 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. | Posted | Number | Infections | Up to Month 5 |
|
|
|
| Secondary | Number of Hospitalizations Over Time | 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. | Posted | Number | Hospitalizations | Up to Month 5 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group (No Cohorting) - Residents | Residents at SNFs where no cohorting has been assigned. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Intervention Group (Cohorting) - Staff | Staff at SNFs where the cohorting strategy has been assigned. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Control Group (No Cohorting) - Staff | Staff at control SNFs where no cohorting strategy has been assigned. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |