COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
Phase: NA
Conditions: COVID-19
Sponsor: NYU Langone Health

 
 
Official Title: 
COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)   
NCT Number: 
NCT05270980 
Study Number: 
20-01281 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
August 16, 2021 
 

 
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COVID-19 Serology Strategies in Skilled Nursing Facilities  
(CERO) 
 
Protocol  
 
Version 3.1 
Updated as of 8/11/21 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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A. SPECIFIC AIMS: COVID-19 SEROLOGIC STRATEGIES FOR SKILLED NURSING FACILITIES 
The COVID-19 pandemic is a public health crisis that has been particularly devastating for older persons with 
Alzheimer’s disease and related dementia (ADRD), especially those living in close congregant environments.1,2,3 
The largest proportion of COVID-19 deaths in many states has been in skilled nursing facilities (SNF),5 in which 
over 60% of residents have ADRD.2 These residents are particularly high risk for acquiring and spreading the 
infection due to their heavy reliance of staff for their personal care and their inability to comply with prevention 
behavior practices, such as social distancing, isolation and wearing masks.4,5 Moreover, ADRD residents are 
especially vulnerable to the adverse social sequelae of COVID-19 outbreaks, such as cessation of routine 
activities, lack of visitation by their loved ones, and heightened confusion related to interacting with caregivers 
in protective gear. Taken together, compassionate and scientifically sound strategies to limit the spread of 
COVID-19 in SNFs are critical to mitigating the adverse effects of this devastating pandemic on the millions of 
residents with ADRD, their professional caregivers, and their family members. 
A main strategy for monitoring COVID-19 in SNFs focuses on PCR testing. Asymptomatic infection 
challenges our ability to achieve isolation practices without complete isolation of all residents, yet the optimal 
protocol for such testing is unclear. Currently, PCR specimens are obtained through nasopharyngeal swabs; an 
uncomfortable procedure that is especially challenging to conduct in ADRD residents with a propensity for 
agitation. Additional problems with PCR testing include suboptimal sensitivity, making viral screening insufficient 
for infection control.6 Furthermore, inadequate attention has been paid to front-line nursing home staff, who 
deliver the majority of personal care to ADRD residents.5,7 Infection rates have been high among nursing staff 
resulting in fear in delivering care and reluctance to even come to work.8 
In sum, as the COVID-19 pandemic continues to ravage US 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. To our 
knowledge, no SNFs have utilized a combined COVID-19 PCR/serology (antibody) testing-based strategy to 
dictate resident-staff assignments to decrease risk of exposure from COVID-19. Blood samples to obtain 
serology status and emerging saliva-based PCR tests also have the potential advantage of being less 
burdensome to obtain than nasal swabs from ADRD patients. 
Despite the evolving landscape in nursing homes with the arrival of COVID-19 vaccines, the objective is 
to continue to pilot test an intervention that leverages COVID-19 and PCR status to pair SNF staff with residents 
in the safest way possible. However, with vaccination, serologic tests may be less meaningful as either may 
afford adequate protection. For that reason, we will only seek serology from individuals with no vaccination or 
no confirmed prior COVID-19 infection. If an individual has received the COVID-19 vaccine, we will not seek 
serologic testing because a negative test does not indicate a lack of protection. (Current commercially available 
serologic testing does not detect antibody formation derived from being vaccinated.)  Specifically, we propose 
to pair residents and staff based on the following three conditions: 1) completed vaccination; 2) prior COVID-19 
PCR positive testing; and 3) positive serology, if available. We will pair COVID-19 negative residents with 
antibody-positive/PCR-negative staff and COVID-19 antibody-positive/PCR-negative residents with antibody-
negative/PCR negative staff. For our pairing strategy, having a completed vaccination is equivalent to prior 
positive PCR or positive serology. The main clinical outcome of this novel staff-assignment strategy will be a 
reduced COVID-19 incidence rate compared to SNF units not using this approach. The pilot project will be done 
in two facilities with high minority and ADRD representation––Terrence Cardinal Cooke and Mary Manning 
Walsh of New York City, NY. To ensure the highest likelihood of successful implementation, we propose a 
phased approach to this research, reflected in following three specific aims: 
1. Develop a staff-resident assignment protocol based on vaccination, history of positive PCR COVID-19 test 
and positive COVID-19 serology testing (when applicable). This strategy will be feasible, scientifically sound, 
and acceptable to key stakeholders, particularly residents with ADRD and their families using the following 
approaches: 1) Semi-structured interviews (one-on-one interviews) including administrators, clinical leaders, 
front-line staff, residents and family members; additionally, because of the increase in staff stress––both work-
related and personal––we are interested in understanding how mental health issues may influence attitudes 
about new programs and changes in usual practice. Therefore, we are including a brief mental health 
assessment for unit staff only and 2) Panel of experts familiar with the NH environment including: industry 
leaders, infection disease specialist, dementia expert, health equity expert, and bioethicist. We will develop 
protocols for: 1. Staff-resident assignments, 2. Serology (if applicable) or PCR testing and vaccination and 3. 
Implementation monitoring.  

 
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2. Employ a testing protocol based on vaccination, PCR, or serologic testing in each of the two SNFs among 
staff and residents to establish their baseline status and three and six months later using on-going surveillance 
testing.  
3. Implement a SNF-unit staffing assignment strategy pairing COVID-19 negative and positive residents with 
staff based on protocols developed in Aim 1. To ascertain feasibility for a larger trial we will measure: i. COVID-
19 resident incidence (primary outcome); ii. COVID-19 staff incidence; and iii. hospital transfers for COVID-19. 
We will assess implementation by: 1) % intended staff assignments achieved; 2) reasons for success/failure; 
and 3) intervention acceptability using exit interviews with staff, residents, and family members, with particular 
focus on the impact of the intervention on ADRD residents and their families. 
IMPACT Establishing vaccine effectiveness in an older and frail population is an ongoing effort. In the meantime, 
more immediate strategies to address rapid spread and excessive mortality due to COVID-19 are greatly 
needed. We anticipate that this pilot study will set the stage for a larger trial that will ultimately set evidence-
based policy for SNF staff-resident assignments that minimize risk of acquiring COVID-19, and directly improve 
the care of millions of Americans with ADRD. 
 
B. SIGNIFICANCE 
The COVID-19 pandemic has greatly impacted the United States. This public health and clinical crisis has been 
especially devastating for older persons, in particular, for those with ADRD where death rates have been among 
the highest.8 Residents of skilled nursing facilities (SNF) where ADRD is highly prevalent have been most 
impacted, as a high-risk population living in close congregant quarters, requiring frequent need for personal care, 
with inadequate testing needed for thoughtful isolation practices and inadequate personal protective equipment 
to limit spread.9,10 In particular, those with ADRD are more challenged, often unable to conduct self-prevention 
behaviors further increasing risk for themselves and others. Social isolation and wearing masks are certain to 
create confusion for those cognitively challenged. Moreover, communication through a mask is further 
exacerbated11 when dementia is accompanied by hearing loss, a common co-occurring condition.12 Other 
isolation strategies are needed. As of May 11th, over 30% nursing homes in 30 states had at least one 
documented case (2,949 of 9,395).13 Urban location as well as greater percentages of African American 
residents significantly increased incidence.13 More importantly, Five-Star rating, prior infection control citations, 
Medicaid dependency, and ownership were not associated with infection rates, which are clearly difficult to 
control.9 In the absence of antiviral therapies, serologic testing is likely to be employed as a prevention practice, 
reflecting the history of efforts in hepatitis and HIV prevention. Serologic testing offers great promise for 
minimizing transmissions recognizing that there is still much to be learned about test accuracy and the 
relationship between antibody presence and reinfection. 
 
It should not be surprising that COVID-19 infections in SNFs are widespread and death due to infection is 
common. Death is likely to be even higher in residents with ADRD who are unable to report symptoms, thus 
delaying needed medical care. Long-term care facility deaths have been among the largest proportion of state 
reported deaths and several-fold higher when considered as a proportion of those infected who die.5 Recognizing 
that the U.S. has now exceeded 100,000 deaths overall due to COVID -19, as of May 2020, nursing home 
residents accounted for more than one-third of the then 80,000 deaths in the U.S.14 How many who have died 
and had ADRD is unknown. The best-known example was the first – a facility in King County, Washington when 
the first index case was identified on February 28th, 2020. By March 18th 167 persons were diagnosed and linked 
to this index case within two Washington Counties. Among 118 tested facility residents, 101 were positive for 
COVID-19 and 35 had died.9 Over half of all residents were hospitalized. Fifty health care personnel, another 
constituency of great concern, had COVID-19. In New York State, the site for this pilot study, state officials 
identified 86 facilities with at least five COVID-19 related fatalities and over 300 New York facilities had at least 
one.11 But because the federal government did not require reporting prior to May, underreporting is likely to be 
systemic and post-dates the period of high disease prevalence in March and April.15 
 
Suspected asymptomatic spread also appears to be high in these settings,8 which requires a more rigorous 
approach for isolation of affected residents from those who are not and removal of staff with identified infections. 
Some facilities such as those in this pilot (where ADRD prevalence is high) are engaged in frequent testing of 
residents and staff, a practice which leads to isolation of all affected residents, and reductions in personal care. 
This approach also results in cessation of meaningful activities and harmful social isolation, further compounded 
by greater staffing shortages. While the heightened risks for SNF residents are indisputable, less attention has 

 
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been focused on front-line nursing home staff, such as licensed vocational nurses who deliver the majority of 
personal care and are at greatest risk to infect themselves and the residents they care for. Infection rates have 
been high among nursing staff resulting in fear in delivering care and reluctance to even come to work. To 
address staff shortages, CMS has waived the requirements (42 CFR 483.35(d)16,17 of nursing facilities to not 
employ anyone for longer than four months unless they have met training and certification requirements under 
483.35(d).17 To ensure the health and safety of nursing home residents, CMS will continue to require facilities to 
ensure that individuals are competent to provide nursing and nursing related services for nurse aides working 
full time for more than four months. This relaxation in training and certification may further compound the need 
for careful infection control. Moreover, an increase in prevalence of behavioral challenges for those with ADRD 
arise from changed routines, unfamiliar faces shrouded in masks, and more difficult communication due to 
hearing loss from a lack of facial expression/lip reading. An experienced staff to manage these challenges and 
who are not out of work due to COVID-19 illness becomes an even more critical need. 
 
C. INNOVATION 
This study is innovative for several reasons: 1) a resident-staff cohorting strategy based on a) completed 
vaccination; b) prior COVID-19 PCR positive testing; and c) positive serology has to our knowledge, never been 
utilized for infection control in any healthcare setting: 2) although stakeholder-influenced study designs have 
been increasingly utilized, employing a multi-stakeholder approach to design a facility-specific testing and 
cohorting strategy is highly innovative and ensures a greater engagement and fidelity across all involved sectors; 
3) a detailed implementation design to capture values, changing attitudes, structural and cultural barriers to a 
testing and cohorting strategy is also innovative and will greatly serve larger trials and best practice 
disseminations; 4) comparing primary outcomes and infection rates between those with and without ADRD is 
novel; and 5) the use of smartphone based technology to facilitate proper cohorting while increasing fidelity is 
highly innovative and ensures greater capture of deviations from the intended approach. Additionally, this 
approach can benefit facilities in their effort to increase contact-monitoring amongst staff and residents.   
 
D. METHODS AND APPROACH 
D.1. Overview: This one-year cluster-randomized pilot study will be conducted in three phases. We have 
engaged two NYC facilities as the sites of the proposed study, where (Phase 1: AIM 1 – one month) we will 
convene all stakeholders (leadership, staff, residents, and their families) and engage a panel of experts to create 
a feasible, scientifically sound protocols for staff-resident assignments based on serology (if applicable), 
vaccination and PCR testing protocols, and Implementation monitoring. In the second phase (Aim 2 – two 
months), we will identify four units (average 40 residents per unit) in each facility. We will stratify the two NHs 
and then within each SNF, randomly allocate two units to the intervention arm and two units to the control arm 
(we have confirmed homogeneity across these four units in each SNF supporting no need for further 
stratification). We will conduct baseline serology and/or PCR COVID-19 tests from residents and staff on all four 
units in each SNF. 
In phase 3 (Aim 3 – six months), we will introduce the staffing assignments based on 1) completed vaccination; 
2) prior COVID-19 PCR positive testing; and/or 3) positive serology in the two intervention units, while in control 
units will employ usual staffing assignments currently in practice in the facilities and only introduce the “concept 
of” a cohorting strategy. COVID-19 PCR testing will occur in all eight units with a regular frequency (testing 
frequency changes based on government guidelines) and whenever an individual is symptomatic. The primary 
outcome will be incidence of COVID-19 infection in residents and as secondary outcomes will include the 
incidence of COVID-19 infections in staff and hospital transfers due to COVID-19-related symptoms among 
residents. Implementation assessment will include: 1) proportion of designated staff assignments achieved and 
reasons for successes and failures; and 2) intervention acceptability using exit stakeholder interviews, with a 
focus on the experience of ADRD residents. Although the analyses will compare intervention and control units 
on the primary outcomes of infection incidence and hospitalization, we do not anticipate either event rate to be 
large enough to reach statistical significance at traditional levels of probability. As real-world management of 
COVID-19 is rapidly changing, we anticipate that the protocol will continue to evolve over time in terms of testing 
frequencies and the capacity to assign residents and staff consistent with our strategies. The protocol will be 
flexible to accommodate such changes. For example, both facilities are launching a SNF-wide resident testing 
strategy and are responsive to federal testing guidelines. Should a reliable PCR test emerge that is less invasive 
than the nasopharyngeal swab, we will adopt it into our protocol. Currently no staff member who tests positive 

 
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for COVID-19 is allowed to work. Thus, staff-resident assignments will be based on 1) completed vaccination; 
2) prior COVID-19 PCR positive testing; and 3) positive serology (when possible) among staff and residents.  
D.2. Setting and Participants: We are conducting the proposed trial in two nursing facilities in NYC: Mary 
Manning Walsh (MMW) and Terrence Cardinal Cooke (TCC). Both facilities operate under the umbrella of the 
ArchCare Organization, a non-profit corporation that owns and operates five nursing facilities in addition to other 
older age care services. Dr. Chodosh and his team have been actively engaged in a research study (SLUMBER 
R01NR016461-01) in these facilities and others that involves staff education to promote better sleep, work that 
has led to smartphone-based educational reinforcements, which will support the proposed intervention. Both 
facilities care for a large proportion (>60%) of residents with dementia. Both facilities are also are diverse: 20% 
LatinX in MMW and 25% African American in TCC and there are 362 and 485 residents in these facilities, 
respectively. MMW recorded over 30 COVID-19-related deaths by the third week in April (the highest nursing 
home death rate in New York State at that time) and TCC had more than 20. Both facilities are currently 
mandating weekly testing of all staff and are conducting their first-wave resident tests for all residents and anyone 
with symptoms. Plans for repeated resident testing will follow CDC guidelines, which are expected to evolve 
over the next few months. Intervention participants include four groups: leadership, staff, residents and family. 
For leadership and family, they will participate in the institution’s effort to develop a strategy for reducing COVID-
19 infections by providing guidance to testing, staff assignment strategies and ongoing feedback based on 
periodic process data collection, analysis and reports. Staff and residents will follow the guidelines and 
requirements of the facility, which will be implemented on two units as a quality improvement initiative. 
 
D.3. Methods for Aim 1: 
Aim 1: To develop a staff-resident assignment protocol based on 1) completed vaccination; 2) prior COVID-19 
PCR positive testing; and 3) positive serology (when possible) that is feasible, scientifically sound, and 
acceptable to key stakeholders, particularly residents with ADRD and their families using the following 
approaches: 1) Facility-specific semi-structured one-on-one interviews including administrators, clinical leaders, 
front-line staff, residents and family members; brief mental health survey for unit staff only, as an important 
potential covariable, and 2) Panel of experts familiar with the NH environment including: industry leaders, 
infection disease specialist, dementia expert, health equity expert, and bioethicist. We will develop protocols for: 
1. Staff-resident assignments, 2. Serology (if applicable) and PCR testing, and 3. Implementation monitoring. 
D.3.a. Stakeholder meetings: All meetings will be recorded and transcribed with permission of meeting 
participants. At the earliest period of study, we will hold two leadership meetings that include both leaders at the 
organization level and individual facility level. Leaders will include Senior Vice President, Chief Medical Officer, 
Chief Information Officer, facility-level Medical Directors and Nursing Directors as well as any other individuals 
to be invited at the discretion of ArchCare. At the facility level, Chief Medical Officer, Director of Nursing, and 
unit-level leadership will attend two initial meetings and then will meet weekly, bi-weekly or monthly thereafter. 
These meetings will address: 1) unit selection; 2) viral testing (PCR and Serology) strategies; 3) marketing 
approaches for residents and families; 4) staff education strategies for implementation; 5) current in-facility data 
collection and staffing strategies; 6) data retrieval strategies (e.g., from electronic health records) for completed 
vaccination, PCR or serology tests 7) use of an external smartphone application to facilitate cohorting methods 
and monitoring; and 8) human subject consent strategies.  
 
The rationale for two initial leadership meetings is: 1) the need for brevity (shorter meetings), ensuring logistical 
feasibility; 2) bidirectional information giving to ensure greatest collaboration and grounding in the intervention; 
and 3) anticipated need for follow-up based on questions that arise from the first meeting or subsequently needed 
revisions in the planned protocol. Weekly meetings with unit leadership including individual staff members, as 
needed will review most recent data on infection rates, hospitalizations, and process measures focused on 
intervention fidelity. Leadership will hold family informational meetings and solicit feedback prior to study initiation 
and resident meetings on the units where a staff- assignment strategy will be implemented. We anticipate that 
resident meetings will be conducted individually and not as groups given the likelihood that congregant meetings 
will not be allowed. Additional meetings with stakeholder groups will occur no less frequently than monthly and 
may be brief weekly “check-ins” as needed. We will (with permission) record all meetings if possible and take 
notes. No attendee identifiers will be included. 
 
We will conduct semi-structured one-on-one interviews in-person or using a WebEx or Zoom meeting structure. 
When necessary or most expedient, we will conduct individual telephone-based interviews. Whereas our goals 

 
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for obtaining qualitative data are implementation-specific and not exploratory, strategies used in exploratory work 
are germane to this work including the use of open-ended questions and thematic analytic approaches. These 
methods increase the yield of valuable and actionable information where the interviewer or interviewee has 
incomplete knowledge, which is required for establishing most feasible and effective strategies. These methods 
also ensure greater democratization of knowledge and establish a collaborative spirit embodied in respect, 
mutual cooperation, and trust, all of which will be critical to success especially during these times of strong 
emotions and potentially grave consequences. We will audio record where permissible and regardless of that 
determination, we will take detailed notes. In addition to documenting key decisions, we believe that some of the 
deliberations will reveal and highlight key perspectives and sensitivities that will need to be considered and will 
inform not only this strategy but future SNF-level intervention strategies that require an abrupt departure from 
usual practice. 
 
D.3.b. Expert Panel Meetings: We will convene a Panel of Experts familiar with the NH environment that will 
include two industry leaders, an infection disease specialist, a dementia expert, health equity expert, and a 
bioethicist. The bioethicist, dementia expert, and health equity expert will be drawn from the Cores and Teams 
of the IMPACT Collaboratory. We will meet with our Expert Panel prior to study initiation and quarterly over the 
year of study. 
 
D.4. Methods for Aim 2: 
Aim 2: Employ a protocol based on 1) completed vaccination; 2) prior COVID-19 PCR positive testing; and 3) 
positive serology (if applicable) in each of the two SNFs among staff and residents to establish their baseline 
status and three and six months later using on-going surveillance testing. 
D.4.a. Testing Protocol and Data Entry: The facility will conduct periodic PCR testing based on CDC guidance 
and will test additionally based on individual symptom or exposure-related concerns. Modifications to the testing 
strategy will be based on collaboration between facility leadership and our infectious disease expert. Given the 
discomfort of a deep nasopharyngeal swab, we will use, if deemed acceptable at the time the pilot study is 
conducted, a saliva-based PCR test to identify active infection and the frequency of testing will be based on a 
collaborative decision between our infection disease expert (Dr. Shopsin) and facility leadership. Collection of 
completed vaccination and/or prior COVID-19 PCR positive testing records or positive serology testing will occur 
at baseline and at three and six months but the frequency may be modified based on new discoveries as our 
understanding of this virus evolves. The laboratory providing results will present testing results to the facility in 
a timely manner, if possible, and those results will also be transmitted to our study team. Although it is best that 
the facility maintain responsibility for populating their health records, we will confirm their interest in using our 
REDCap database and we will closely monitor those entries to ensure accuracy and present timely feedback 
using a standard audit and feedback process. We have successfully used this approach in other nursing home 
studies focused on depression care.18 For any resident moving into an intervention unit, the default status will 
be ‘COVID-19 negative’ until vaccination completion records or prior COVID-19 PCR positive status is known, 
or if serology testing is performed. We also anticipate completed vaccination, prior COVID-19 PCR positive 
testing and serology results will be collected at baseline, three and six months but a different set of frequencies 
for testing will also be considered. Test results will be maintained at the level of the individual resident and 
labeled for easy recognition by facility and unit. Weekly meetings between study team, the facility designated 
data manager, and staff leadership for each intervention unit (n=4) will ensure data accuracy and quality. 
 
D.4.b. Subject Consent and Regulatory Issues: All human subjects concerns will be reviewed and approved 
by the IMPACT Collaboratory’s Advarra Central Institutional Review Board and Data Safety and Monitoring 
Board. To meet our timeline, these approvals need to be sought as soon as possible. For Aim 1, we will obtain 
consent from participants to take notes and audio record while clearly stating that there will be no subject 
identifiers. Aim 1 will help direct our approach to consent and human subject protections for Aims 2 and 3. 
Residents and staff PCR testing fall under current usual care and are already used to cohort residents. Any 
resident room relocations based on infection status will follow existing SNF institutional policies. However, we 
will need to consider consent processes to obtain serologic tests from staff and residents, use of testing 
information to create staff-resident assignments, and utilizing all data for research purposes. We will request a 
modified consent process (e.g., opt-out, verbal consent) from Advarra IRB but recognize that this may also 
require individual written consent. We will follow all rules and sensitivities with regard to the need for legally 
authorized representatives in the absence of subject capacity to consent.  

 
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D.5. Methods for Aim 3: 
Aim 3: Implement a SNF unit staffing assignment strategy pairing COVID-19 negative and positive residents 
with staff based on protocols developed in Aim 1 in intervention units and introduce a “concept of” cohorting 
strategy in the control units, meaning these units will follow regular facility policy and will not receive staff-resident 
assignments. To ascertain feasibility for a larger trial we will measure: i. COVID-19 resident incidence (primary 
outcome); ii. COVID-19 staff incidence; and iii. hospital transfers for COVID 19. We will assess implementation 
by: 1) % intended staff assignments achieved; 2) reasons for success/failure; and 3) intervention acceptability 
using exit interviews with staff, residents, and family members, with particular focus on the impact of the 
intervention on ADRD residents and their families. 
D.5.a. Randomization of Units: 40-bed facility units are the unit of randomization and we will randomize within 
individual SNFs to select each intervention unit. Should we identify specific unit-level characteristics that are not 
consistent across units (we have been assured there are none) and may influence our outcomes (such as 
median age, other demographics or unit size) we will conduct a stratified randomization. We recognize there 
may be some contamination between staff/residents between intervention/control units but will do our best and 
monitor this “contamination” as one of our implementation fidelity outcomes.  
 
D.5.b. Staff-Resident Assignment Strategy: Within individual intervention units, we will pair care-partners 
(staff) with individual residents, based on 1) completed vaccination; 2) prior COVID-19 PCR positive testing; and 
3) positive serology (if applicable). For serology testing, antibody negative will be paired with antibody positive 
as well as antibody-positive with anti-body positive if the frequency of antibody-positive residents and staff is 
high. Prior known COVID-19 infection and recovery in the absence of vaccination will still require serology testing 
as we do not yet know how to anticipate antibody development and resilience. Contact between two or more 
antibody-negative and unvaccinated individuals (and no history of positive PCR) will be restricted such that no 
antibody negative, unvaccinated individual (and no history of positive PCR) will intentionally interact with another 
antibody-negative, unvaccinated person (and no history of positive PCR), regardless of individual type (resident 
or staff). We anticipate that high staffing ratios (more residents with fewer staff) that require the responsibility of 
one staff person to care for several residents will present considerable challenges to achieving full fidelity, 
particularly on overnight shifts. Although strict cohorting is a primary implementation goal, we anticipate less 
than perfect fidelity. Nonetheless, we believe that any reduction in unnecessary exposure will reduce the risk of 
disease transmission and may lead to meaningful outcomes. Ensuring greatest fidelity will require full 
engagement of clinical leaders (nursing leads) at the unit level but these leaders will require real-time data for 
making staffing decisions. These data should also be available to front-line staff so that there is less opportunity 
for misinformation or lack of information to inform decisions. 
 
D.5.c. Staff-Resident Assignment Decision-Making Tool: Dependent on stakeholder meetings we will 
propose a data-driven decision-making tool built on a smartphone compatible REDCap platform. We have built 
REDCap applications for registry enrollment (NIH/NIA ELM) Research Collaborative 1R24AG063725; Chodosh-
MPI), educational event feedback and community-based research recruitment (NIH/NIA ADRC P30-AG008051-
26; Chodosh-ORE Core Leader), and a nursing staff behavioral support decision-aid (SLUMBER 
R01NR016461-01). Our detailed cohort data is smartphone compatible and interfaces with Tableau© for best 
data visualization to support in-the-moment decision-making. Data capture will be either direct linkage to the 
laboratory testing site or a facility-identified data manager for data entry. Our tool will identify residents and staff 
by unit, type date of test, and test results. We will create a stratification strategy that will include a list of residents 
by COVID-19 status and a connected list of staff who are “cleared” to care for those individuals based on mutual 
test-derived classifications. Data from the two intervention units will be combined to increase the flexibility of 
cross-unit staffing when shortages require staff to work on units that are not their usual work location. We will 
also consider additional serologic testing for staff members who might “float” onto the intervention units. During 
the study period we will pursue an independent software application that does not require a University-based 
software system (REDCap) with an eye towards broader feasibility and dissemination should our findings warrant 
a larger multi-site clinical trial and national dissemination. 
 
 
E. ANALYSES: 

 
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Data Elements Overview: Data includes both quantitative and qualitative measures. Our quantitative main 
outcome measures are the number of new COVID-19 detected infections over time, and number of 
hospitalizations over time. PCR data will be collected at baseline and compared to determine incidence (although 
we expect that this number/ proportion to be quite low). Incident infection data will be entered and collected 
through the REDCap tool described above as will serologic data. We will collect data on hospital admissions at 
the end of each month during the intervention period. We will also collect data on fidelity with respect to testing 
compliance and cohorting. All test results will be maintained in a database that is available to facility and unit 
leadership with identifiers to enable an active and flexible staffing strategy. These same test results will be 
available to our study team but without identifiers. We will collect qualitative data using notes from stakeholder 
meetings and transcribed recordings where permissible. We will gather additional data from exit interviews with 
representatives of each stakeholder group. 
 
We will collect incidence rates for PCR and serologic results as detailed in Section D.4.a. Other variables we will 
collect include using Minimum Data Set (MDS) 3.0 for: resident age, race/ethnicity, gender, function 
(ADL),comorbidities as well as measures that look into anxiety, depression levels, functional disabilities, 
cognitive performance, among others. Data will be requested from three time points 1) pre-COVID-19 (1 year 
before) 2. COVID-19 (as of February 2020) and 3) post-COVID (present time). Staff data will include: age, 
race/ethnicity, gender, and zip code of residence. We will examine differences in outcomes comparing those 
with and without ADRD within intervention and control units. A protocol for obtaining laboratory data either from 
the facility-related clinical lab or directly from the facility will be established following our first leadership meeting. 
Should rapid tests with on-site interpretation become available, we will create a protocol to ensure accurate and 
timely data capture working with leadership at the unit level. We will use unique identifiers to ensure resident/staff 
confidentiality within our database, but the facility managers will require identifiers to achieve their staffing 
strategy using the database and for making best and timely decisions about resident staffing. We will include in 
our REDCap database a tool for listing, by each unit, daily staff/resident assignments. Should unit managers 
want to use another method for monitoring assignments, we will request a daily fax or email of those 
assignments. Each facility medical director at will ensure compliance with data capture. 
 
E.1. Quantitative Analyses: The ultimate goal of developing a serologic strategy is to reduce COVID-19 
infection rates and hospitalizations. In this pilot phase, where the focus is informing the design of a larger 
pragmatic RCT, a key focus will be on the ability to measure the outcomes, incident cases of COVID-19 and 
hospitalizations, in a pragmatic way using administrative data only. Once we have successfully collected these 
data, we will estimate incident rate ratios using Bayesian Poisson models that include resident length of stay in 
the nursing home. The Bayesian model provides a posterior probability distribution of the effect of serologic 
strategy on incidence and hospitalizations. A strength of this analytic approach is that we will be able to conduct 
ongoing interim analyses to understand if and how the strategy is working as we conduct the study. 
 
The COVID-19 analysis will be conducted at the level of the nursing home unit using this model: 
Yi ~ Poisson (λi) 
log (λi) = β0 + β1Ti + log (Ri) 
 
Yi  is the number of incident cases for nursing home unit i, i ∈ [1, 2, … , 8]. Ti is an intervention indicator, Ti = 1 if 
unit i is using the serologic strategy, Ti = 0 otherwise. Ri is the total number resident-days for unit over the 6-
month observation period. The parameter λi represents the modeled mean for site, and λi ⁄ Ri is the incidence 
rate, represented as the number of infections per resident-day. β1 is the effect of interest: the incidence rate ratio. 
We will assume an uninformative prior distribution for β1. The model for hospitalizations will be developed in the 
same manner. Both analyses will be conducted using the latest version of R, which is currently 4.0.0 (R 
Foundation for Statistical Computing, Vienna, Austria). 
 
E.2. Qualitative Analyses: Overview of Qualitative Methodology: This project includes qualitative data from 
key stakeholder meetings and interviews about: 1) perceptions of the testing program and implementation 
strategies; 2) perceptions about staff-resident assignment strategies; 3) barriers/facilitators toward program 
implementation and sustainability including the impact of staffing changes on resident behaviors for those with 
ADRD. Because much of this work is implementation and feasibility-specific, meetings will often be both 
information giving and soliciting of other details, e.g., how is testing being conducted currently. We will use focus 

 
9
group and semi-structured interview guides for these meetings consisting of open-ended questions and probes 
to focus while allowing participants to speak freely. The meeting guides will be adapted from tools used in the 
formative phase to assess acceptability of the intervention and feasibility of strategies. 
 
E.2.a. Qualitative Analysis Plan: The qualitative data will be analyzed using content thematic analysis.19 When 
possible, meetings and interviews will be audiotaped and transcribed verbatim, with accuracy confirmed, and 
coded using ATLAS.ti version 8.0,20 a powerful analytical tool for qualitative analysis. When taping is not 
possible, these discussions will be captured through extensive notetaking. Dr. Dickson, an expert in qualitative 
and mixed methods research will oversee all phases of the qualitative analysis including the data integration 
phases. Preliminary analysis will include a line-by-line review yielding clusters of data that we will label into brief 
headings. We will derive codes from these data linked to meeting/interview questions and coding categories. 
We will summarize coding categories within-cases, then across cases, subsequently cross-classified to yield a 
rich descriptive analysis.21 Finally, we will identify emerging themes both within and across coding categories; 
and verify a review of data fit. For the key stakeholder meetings/interviews, we will analyze data site by site and 
then across sites to identify site-specific data as well as overarching themes. In the final analysis stage, we will 
integrate qualitative and quantitative site/unit-specific data to describe implementation barriers and facilitators. 
We anticipate that the qualitative data will also reveal factors that influence understanding (e.g., interpretation of 
serology results, what constitutes meaningful and at-risk contact). In the final analytic phase, we will use 
informational matrices, a type of joint display22 to integrate the stakeholder qualitative data and the resident 
outcome data to describe the mechanism of testing and cohorting effectiveness. Methodological rigor23 
throughout all phases of this analysis will be assured by training of research staff who will do initial coding, 
assessing inter-coder reliability, an audit trail of analytic decisions, regular meetings with experts and member 
checking, the process by which findings are validated as representative of the experience of the participants.  
 
F. PROJECT MANAGEMENT PLAN AND TIMELINE 
Please see Biosketches for qualifications of co-investigators. A GANTT chart is included here. Dr. Chodosh 
will have responsibility for all aspects of study design and execution. We have already established meetings 
with ArchCare leadership in developing this proposal. This will serve as an excellent conduit to a rapid launch 
should this study be funded. His senior research coordinator, Diana Hernandez is bilingual and has an 
excellent rapport with facility staff at both MMW and TCC. Ms. Hernandez will work closely with ArchCare 
leadership and facility staff to coordinate all meetings and will serve as the go-between for the research team 
and facility staff. Dr. Shopsin has expertise in serologic and PCR testing and will facilitate that process and 
data interpretation. His close working relationship with his NYU colleagues ensures that new discoveries will 
more readily be integrated into pilot work where appropriate and deemed to be of benefit. Our team is also 
benefitted by the counsel and expertise of the NIA IMPACT Collaboratory including, bioethics, dementia, 
health equity, implementation, stakeholder concerns, and pragmatic statistical design. We will meet 
periodically with Collaboratory experts for ongoing advice and specific direction where needed. 
 
 
 
 

 
10 
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