IMPACT-C: Improving Vaccine Uptake in Skilled Nursing Facilities
Phase: NA
Conditions: COVID-19 Vaccines
Sponsor: Brown University

IMPACT-C protocol v1.5 April 7, 2021 
i 
IMPACT-C:  
Improving Vaccine Uptake 
in Skilled Nursing Facilities 
Protocol  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
IMPACT-C: IMPROVING VACCINE UPTAKE IN 
SKILLED NURSING FACILITIES 
Principal Investigators: 
Vincent Mor, PhD 
Professor of Medicine, Brown University School of Public Health 
 
Sarah D. Berry, MD MPH 
Associate Professor of Medicine, Marcus Institute for Aging Research, Hebrew SeniorLife 
 
 
Supported by: 
 NIA 3U54AG063546 
 
 
Version 1.5  
April 7, 2021 

IMPACT-C Protocol v1.5 April 7, 2021 
 
1 
PRÉCIS 
1.1 Study Title:  IMPACT-C: Improving Vaccine Uptake in Skilled Nursing Facilities 
1.2 Objective  
SARS-CoV-2 vaccine, now being administered to SNF residents and staff, has highly variable 
acceptance between facilities. We need to develop and disseminate effective strategies to 
increase vaccination immediately. For SNF residents and staff we will develop and implement a 
scalable multi-pronged intervention that educates, builds trust and supports the informed consent 
process aimed to increase SARS-CoV-2 vaccination. We will compare the rates of vaccination in 
staff and residents in facilities that receive electronic messaging and education (i.e., ususal care) 
versus rates in facilities that receive an additional multi-pronged “high touch” intervention. 
 
1.3 Design and Outcomes 
Design 
We will conduct a cluster randomized trial to compare the effect of electronic messaging and 
education (i.e., usual care) versus a multi-pronged “high touch” intervention to reduce vaccine 
hesitancy in SNF staff and residents among a random sample of facilities across four SNF 
chains. As part of the “high touch” intervention, we will identify and train local opinion leaders. 
We will offer these leaders assistance through real-time support for questions and provide 
consenting specialists. During the second wave of vaccination, we will provide the intervention 
facilities with positive reinforcement for staff and we will identify local champions to garner 
support and empowerment of staff. Finally, in the intervention facilities we will provide 
additional funds to support COVID-19 testing, in order that facilities have access to enough 
testing kits for patient or staff who develops symptoms following vaccination. 
This trial will be randomized within 4 SNF chains in order to evaluate the effect of a multi-
pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-
stay nursing home residents. In four chains, eligible facilities will undergo randomization 
between usual care versus adding the “high touch” intervention, implemented in two waves. 
Randomization and roll out of the intervention will occur at the facility level.   
Outcomes 
The following outcomes related to SARS-CoV-2 vaccination will be measured during the period 
of vaccine administration and followup:  
PRIMARY OUTCOME:  
A binary measure (Yes or No) indicating whether a long stay nursing home resident received any 
doses of a SARS-CoV-2 vaccine, identified by the electronic medical records (EMR) 
 
SECONDARY OUTCOMES: 

IMPACT-C Protocol v1.5 April 7, 2021 
Number of direct care staff who received any dose of a SARS-CoV-2 vaccine 
 
 
 
1.4 Interventions and Duration  
The entire trial will take place over 11-15 weeks, each intervention facility will be involved in 
approximately 1-3 week start up activities, 6-8 weeks of vaccine administration (in all facilities, the 
vaccine will be offered on three dates approximately 3-4 weeks a apart), and an additional 4 weeks of data 
collection. Intervention homes will follow the same timeline for enrollment and data collection. During 
the start-up period in the intervention facilities, the research team works with the leadership and opinion 
leaders in each SNF to optimize program roll-out within each unique environment.   
Numerous educational resources regarding vaccination already exist. Through the American Health Care 
Association (AHCA), our team plans to disseminate electronic messaging and educational material 
regarding the COVID-19 vaccine to 12 SNF chains with some 1,000 facilities including around 100,000 
direct care staff and at least 60,000 long-stay residents. This quality improvement initiative represents 
typical care practices (i.e., usual care), and it will include all facilities in the four chains that will take part 
in the trial. Select facilities within the four chains will additionally receive the “high touch” intervention, 
offered in two waves. 
1.5 Sample Size and Population  
The study sample will include some 150 facilities including around 14,000 direct care staff and 
at least 8,500 long-stay residents across 4 SNF chains.  
 

IMPACT-C Protocol v1.5 April 7, 2021 
2. STUDY TEAM ROSTER  
2.1 Principal Investigator 
Vincent Mor, PhD                                                                                                                             
Florence Grant Price Professor School of Public Health, Brown University School of Public Health                                      
Email: vincent_mor@brown.edu                                               
Role: Dr. Mor is the PI for the IMPACT-C supplement and will be responsible for all aspects of the trial. 
Specifically he will oversee the recruitment of eligible NFs and the budget for Brown University and 
subcontract to Insight Therapeutics.   
Sarah D. Berry, MD, MPH  
Research Scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Associate Professor of Medicine, Harvard Medical School  
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5355, Fax: 617-971-5339   
Email:    SarahBerry@hsl.harvard.edu 
 
Role: Together with Dr. Mor, Dr. Berry will be responsible for all aspects of the trial. Specifically she will 
work with Dr. Gravenstein, McConeghy and Goldfeld on the trial design, and with Dr. Johnson, Dr. 
Jackson, and Insight Therpeutics on the development and implementation of the intervention. She will be 
responsible for budget management of the HSL site, and the management of the Project Director. She will 
be responsible for annual project reports to the NIH and IRB approval.  
2.2 Co-Investigators: 
Stefan Gravenstein, MD, MPH                                                                                                                                
David S. Greer Professor of Geriatric Medicine, Director Division of Geriatrics and Palliative Medicine, 
Brown University 
 401-369-4131; 401-444-5248 (w)                                                                                                                                 
Email: Stefan_Gravenstein@brown.edu 
 
Role: Dr. Gravenstein is an investigator at Brown University with several decades of clinical vaccine and 
antiviral trials experience in nursing home populations. For the proposed project, Dr. Gravenstein will be 
instrumental in developing the analytic approach and overseeing the implementation of the intervention.   
 
Kevin McConeghy, PharmD, MS                                                                                                               
Email: Kevin_McConeghy@brown.edu 
 
Role: Dr. McConeghy is an investigator at Brown University with a background in 
pharmacoepidemiology and clinical trials, and has worked on large cluster-randomized clinical vaccine 
trials with Dr. Gravenstein for 4 years, participating in methods, and leading analytic work. For the 
proposed project, Dr. McConeghy will be responsible for overseeing data collection elements from the 
facilities, and participate in analytic work related to this trial. 
   
Keith Goldfeld, DrPH                                                                                                                                       
Email: Keith.Goldfeld@nyulangone.org 
 

IMPACT-C Protocol v1.5 April 7, 2021 
Role: Dr. Goldfeld is a senior statistician at NYU, and he has more than a decade of experience with 
clinical trials in frail, older populations. For the proposed project, Dr. Goldfeld will be responsible for the 
developing the analytic approach to the trial, handling missing data, and overseeing the interpretation of 
the analyses.  
 
Susan Mitchell, MD MPH:  
Senior Scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Professor of Medicine, Harvard Medical School  
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5326, Fax: 617-971-5339   
Email:    smitchell@hsl.harvard.edu 
 
Role: Dr. Mitchell is a senior investigator at the Institute for Aging Research, Hebrew SeniorLife and the 
co-Director of the Interventional Studies in Aging Center (ISAC). Dr. Mitchell has considerable 
experience in the design and implementation of pragmatic clinical trials in the nursing home setting, and 
in particular among persons with Alzheimers Disease and Related Dementias (ADRD). Dr. Mitchell will 
provide insight during the implementation phase of the trial. 
Jonathan Jackson, MD                                                                                                                                  
Email: jjackson31@partners.org 
Role: Dr. Jackson is a senior investigator at Massachusetts General Hospital with expertise in 
understanding racial disparities in healthcare. In the proposed project, Dr. Jackson will serve to inform the 
implementation of the intervention, as well as to inform the analytic approach to understand within 
facility differences in the effect of the intervention 
Edward Davidson, PharmD, MPH                                                                                                                                          
Phone: 757-625-6040 
Email: edavidson@inther.com 
Role: Dr. Davidson is a Partner of Insight Therapeutics, with expertise in nursing home educational 
campaigns and implementing pragmatic clinical trials.  He will be responsible for the implementation of 
the intervention. This includes identification of the facility champion, production of a series of 
educational videos, delivery of frequently asked questions, distribution of items to publicize vaccination, 
and facilitating education. 
 
Lisa Han, MPH                                                                                                                                                     
Phone: 757-625-6040 
Email: lhan@inther.com 
Role: Ms. Han is a partner of Insight Therapeutics, with expertise in nursing home educational campaigns 
and implementing pragmatic clinical trials. She will be responsible for overseeing implementation tasks, 
including educational material production, project website development, material distribution, and 

IMPACT-C Protocol v1.5 April 7, 2021 
champion education and support. She will provide strategy and operational oversight and support for the 
high touch intervention.    
David Gifford, MD, MPH                                                                                                                                      
Email: dgifford.ahca.org 
Role: Dr. Gifford is the Director, Center for Health Policy Evaluation in LTC at American Health Care 
Association. He will provide access and facilitate participation to the SNF chains. He will additionally 
provide crucial feedback on the implementation process and requirements for consent that will be 
necessary for this proposal.   
2.3. Consultants 
Kimberly Johnson, MD  
johns196@mc.duke.edu  
(919) 660-7506 
 
Role: Dr. Johnson is a Duke geriatrician and palliative care physician, and national expert on health 
disparities. In the proposed project, Dr. Johnson will serve as an expert to moderate some of the 
informational sessions for staff and as a consultant to advice on the implementation of the intervention. 
 
Chris Rowley, MD 
Crowley1@bidmc.harvard.edu 
 
Role: Dr. Rowley will provide expertise and advice on COVID-19 testing, as well as emerging testing 
technology.  
 
Michael Mina, MD 
Email: mmina@hsph.harvard.edu 
 
Role: Dr. Mina will provide expertise and advice on COVID-19 testing, as well as emerging testing 
strategies. 
 
2.4. RESEARCH TEAM MEMBERS 
 
Maggie Syme, PhD 
Project Director, Hinda and Arthur Marcus Institute for Aging Research                                          
Address: 1200 Centre Street, Roslindale MA  02131                                                                                      
Phone: 617-363-8000                                                                                                                                     
Email:  Maggie.l.syme@gmail.com                                                                                                                                    
 
Role: Dr. Syme will work closely with Dr. Berry to oversee all aspects of the trial.  This includes 
regulatory compliance with the award, organizational meetings, trouble shooting problems with the 
facility champions, and facilitating the collection and analysis of data. 
 
Amy Recker, MPH 
Project Director, Brown University School of Public Health 
Email: amy_recker@brown.edu 
 

IMPACT-C Protocol v1.5 April 7, 2021 
Role: Ms. Recker will work closely with Dr. Berry and Dr. Mor to help coordinate and oversee all aspects 
of the trial. This includes organizational meetings, contact and support to facility champions, and 
facilitation the collection and analysis of data.  
  
 
Laurie Herndon, NP                                                                                                                                         
Email: laurieherndon@hsl.harvard.edu 
Role: Ms. Herndon will work with Drs. Berry and Johnson to facilitate the training sessions for the 
facility opinion leaders. 
 

IMPACT-C Protocol v1.5 April 7, 2021 
 
3. STUDY OBJECTIVES 
3.1 Primary Objective 
Aim 1: To conduct a cluster randomized controlled trial (~150 facilities across 4 SNF 
chains) to compare the number of SNF residents who receive the SARS-CoV-2 
vaccine in facilities with usual care versus facilities randomized to the multi-pronged 
intervention.  
 
H1: We hypothesize that the intervention will increase vaccination of SNF residents 
by at least 10 percentage points versus facilities usual care alone. 
 
 
3.2. Secondary Objectives 
 
 
Aim 2. To compare the number of direct care staff who receive any SARS-CoV-2 
vaccination in facilities with usual care versus facilities randomized to the multi-
pronged intervention.  
 
H2. We hypothesize that staff of NFs with the intervention will have at least a 10 
percentage point greater vaccine uptake of vaccine than staff in SNFs that do not 
participate in the high touch intervention 
 
Aim 3. To determine whether the intervention will mitigate resident and staff disparities 
in SARS-CoV-2 vaccination by race/ethnicity. 
 
H3. We hypothesize that within intervention SNFs, improvements in vaccine uptake 
will be similar across staff and resident race/ethnicities. 
 
Aim 4. To assess the experiences of opinion leaders in intervention facilities in terms of 
their perceived barriers to intervention implementation, organizational culture, and 
overall experience with the intervention. 
 
H4: We hypothesize that there will be a high variability in experiences across facility 
opinion leaders that will inform the results of the trial.  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
 
4. BACKGROUND AND RATIONALE 
Epidemiology of COVID-19 in SNFs.  COVID-19 has disproportionately affected nursing facility 
(NF) staff and residents in the U.S., with the highest rates of infection and mortality in both 
groups.[1, 2] Facility outbreaks vary geographically and over time.[3] Aside from morbidity, 
COVID-19 has been extremely costly for NFs due to declining admissions, purchasing of personal 
protective equipment (PPE)[4-6] and testing. It is estimated the U.S. government may pay more 
than $15 billion to cover COVID-19 costs in SNFs alone.[7] 
 
Vaccine availability. Three vaccine candidates are expected to be released in December 2020, 
with SNF direct care staff and residents scheduled to be in the first group in the country to be 
offered the vaccine. The first two vaccines (Pfizer and Moderna) use a novel microRNA 
technology. Phase two trials have already been conducted on over 50,000 and 30,000 persons for 
the Pfizer and Moderna vaccines, respectively, with demonstrated safety and efficacy against 
COVID-19.[8] 
 
Staff barriers to vaccination. Despite the promise of these leading vaccine candidates in 
decreasing the rates of COVID-19 and serious illness, there are many barriers to having SNF 
staff receive the vaccine. First, because the vaccines will all be approved by an Emergency Use 
Authorization (EUA), employers will not be able to mandate that staff receive the vaccine.  
Second, in a recent survey of 1,250 Black and Latinx Americans, only 18% of Blacks and 31% 
of Latinx report that they would definitely get vaccinated if the vaccine were free.[9] This is 
consistent with historical differences in rates of influenza vaccination among Black and Latinx 
populations relative to non-Hispanic Whites.[10] A primary reason many Blacks/Latinx are 
hesitant to accept vaccination is a lack of trust that the vaccine is safe and in the authorities 
(including their employers) advocating vaccination.[9] This is alarming in the SNF setting where 
the largest group of direct care workers are nursing assistants (NA), and 50% of NA identify as 
Black/Latinx.[11, 12] A recent survey conducted by the National Association of Health Care 
Assistants (the major professional organization of NAs), confirmed that most NAs do not plan to 
be vaccinated for SARS-CoV-2.[13] Finally, staff may express vaccine hesitancy give a fear of 
side effects and concern they will be unable to work. Point-of-care COVID-19 testing offers a 
practical solution to determine whether staff who exhibit symptoms following vaccination are 
able to work; however, low resourced facilities are still having difficulty accessing an adequate 
supply of test kits.[14] Therefore, we believe that without a multi-pronged intervention to reduce 
vaccine hesitancy and dispel misinformation, vaccination rates among SNF direct care workers 
will be low, compromising efforts to protect SNF residents. 
 
Resident barriers to vaccination. There are also major challenges to insuring that SNF residents 
are vaccinated. First, historically Black SNF residents are less likely to receive influenza and 
pneumococcal vaccines than are White residents.[5, 6] Most of this difference has been 
explained by inequities in offering the vaccine between facilities rather than within facility 
differences, although these still remain.[15, 16] SNFs are highly segregated along racial lines, 
with resource-poor facilities tending to have larger non-white populations. Second, the first two 
vaccines likely to be released require ultra-cold storage meaning SNFs are not equipped to store 
these vaccines. CMS has encouraged SNFs to overcome this barrier by partnering with pharmacy 

IMPACT-C Protocol v1.5 April 7, 2021 
chains (e.g. Walgreens) that will deliver the vaccine to staff and residents. Even though verbal 
informed consent will be allowed, knowing how many residents and staff will accept the vaccine, 
prior to the vaccine supplier being at the NH, will be critical to minimize waste and maintain 
maximal efficiency given the finite staffing resources available to ensure all NHs are offered 
vaccine in a timely fashion. We anticipate organizing the effort and coordination with the 
pharmacy provider will be an enormous barrier for facilities, but in particular, for the resource-
poor facilities with larger Black and Latinx populations who may not have the capacity to 
systematically reach out to families to inquire about willingness to be vaccinated, obtain a verbal 
or written consent, and manage the documentation needed. 
 
Interventions to reduce disparities in SNFs. Our team has extensive experience in implementing 
interventions to improve healthcare and reduce racial disparities in NFs, including experience 
with influenza vaccinations.[17-19] Based on our experience and a review of interventions 
targeting influenza vaccination in SNFs[20], we anticipate that a multi-pronged approach will be 
necessary to overcome these sizeable barriers and successfully implement the SARS-CoV-2 
vaccine among SNF staff and residents. The multi-pronged approach should include the 
following components: 
1. Electronic Messaging and Education. Messaging promoting prosocial motivations (i.e., 
protecting one’s community from COVID-19) has been demonstrated to be a stronger 
predictor of willingness to practice preventive behaviors for COVID-19 as compared 
with messaging promoting personal motivations (i.e., protecting oneself from COVID-
19).[21]  This is consistent with systematic reviews of interventions to increase influenza 
vaccination in healthcare workers. [22] As part of a quality improvement initiative 
through AHCA, we will disseminate videos of staff from different SNFs stating their 
reason for choosing to be vaccinated. Messages may be disseminated by 12 SNF chains 
by email, text, and on social media. Messages will have links to Frequently Asked 
Questions (FAQs) on the web as well as broader Public Service Announcements (PSAs). 
This electronic messaging and education will be considered the ‘usual care’ of the cluster 
randomized controlled trial described herein.  Only four of these 12 chains will 
participate in the trial itself. 
2.  Facility Opinion Leader. Our own experience in SNFs suggests that providing 
educational material by itself is less effective in changing behaviors than when a facility 
champion is identified among the direct care staff to reinforce the educational message.[23, 
24] In one trial of influenza immunization among SNF staff, researchers noted that staff were 
typically siloed by job type,[25] and thus, multiple leaders should ideally be selected for each 
job type. We plan to identify up to four individuals within each facility who are trusted 
“opinion leaders,” and can receive training so that they may more confidently address 
criticism or questions from their peers.   
 
3. Building Trust Locally. Successful response models to prior epidemics including H1N1 
and Ebola have required strong community engagement and a “bottom-up” approach.[26] 
We plan to work with the facility opinion leaders to identify a local well- respected member 

IMPACT-C Protocol v1.5 April 7, 2021 
of the community (e.g., minister, teacher, health care provider) who will help promote trust 
in the SARS-CoV-2 vaccine.  
4. Positive Reinforcement. Health communication literature suggests that it is equally if not 
more important to address positive emotions (e.g., building altruism and hope) as it is 
negative emotions (e.g., combatting fear and anxiety) when addressing vaccine 
hesitancy.[27] Providing staff goodies (e.g., buttons, T-shirts, masks) as well as promoting 
positive images on social media have been successful strategies in increasing influenza 
vaccination[20] and improving other health behaviors among SNF staff. 
5. Consenting Specialist. Low-resource SNFs will have very limited time or ability to 
counsel proxies on the risks and benefits of receiving the SARS-CoV-2 vaccine. A remote 
consenting specialist could overcome this barrier. 
6.  Testing Supplies. Phase III trials suggest that as many as 16% of persons will experience 
a fever and approximately half experience fatigue and headache, particularly after the second 
dose.[8] The CDC has recently provided guidance on the use of point-of-care COVID-19 
testing following vaccination that may be helpful to determine if staff are able to work or if 
residents need to be isolated.[28, 29] We plan to provide additional funds ($10,000) for 
facilities to use to purchase COVID-19 testing kits, so that these facilities are able to follow 
CDC guidelines for residents and staff who have symptoms after vaccination.  
 
Summary of significance.  
The significance is summarized as follows: 1. COVID-19 has disproportionately affected SNF 
workers and residents; 2. Several SARS-CoV-2 vaccines are expected to be available starting 
December 2020, and facilities will only have a limited number of opportunities to receive the 
vaccine through a consulting pharmacy company; 3. Direct care staff, many of whom are Black 
and Latinx, have expressed considerable hesitancy regarding the safety of the vaccine; 4. There 
is a history of racial disparities in healthcare across SNFs, including a reduced tendency for 
Black residents to receive influenza vaccines; 5. Obtaining clinical consent for vaccination will 
be a second, major barrier to successful vaccination of residents along with obtaining a firm list 
of staff and residents willing to be vaccinated prior to pharmacy vaccinators coming into the NH 
to minimize vaccine waste and ensure efficiency; 6. Low resource facilities often house the 
largest numbers of non-white minority residents, and it will be challenging for these facilities to 
overcome these sizeable barriers to vaccination without additional support; 7. A multi-pronged 
approach that centers on building trust, empowering staff opinion leaders, providing positive 
reinforcement, easing the process of obtaining informed consent for the vaccine, aid in 
organizing the on-site clinic for staff and residents, and ensuring adequate testing supplies is a 
promising strategy to improve acceptance of SARS-CoV-2 vaccination among staff and 
residents.  
 
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
5. STUDY DESIGN 
This will be a cluster randomized trial where the intervention is applied at the facility level. Our 
primary interest is the effect of this intervention on SNFs that are characterized by having a 
relatively high proportion of residents who are Black or Latinx. The 4 SNF chains that have been 
selected have already given assent to participate in this trial. Facilities that are ineligible (e.g., 
institutional instability) have been excluded from the list of facilities for randomization.  
 
We will then stratify facilities into three categories based on racial composition of residents:  
 
(1) < 25% Black and Latinx residents 
(2) 25-40% Black and Latinx residents 
(3) > 40% Black and Latinx residents 
 
Facilities will undergo constrained randomization within each chain and stratum to ensure that 
the proportion of Black and Latinx residents is balanced across the intervention arms. We will 
randomize a total of 60 SNFs to the intervention, allocated proportionally across the strata. The 
SNFs that were removed due to institutional instability  will be compared separately to the 
control arm to assess potential bias due to selection into the study. 
 
The Figure below describes the random allocation of facilities: 
 

IMPACT-C Protocol v1.5 April 7, 2021 
 
 
Staff in facilities randomized to intervention arm will be informed by corporate leadership 
that they will be participating in a program to maximize COVID 19 vaccination among staff and 
residents. They will not be informed that this is part of a trial. Individual SNFs will be 
randomized to the intervention or usual care; randomization will be stratified by chain and by the 
proportion of minority residents based on three groups: <25%, 25%-40%, >40%. The research 
implementation team will not be masked to facility assignment. However, the PIs (Mor, 
Mitchell), the lead statistician (Dr. Goldfeld) and programmers will be masked.  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
6. SELECTION AND ENROLLMENT OF PARTICIPANTS  
The four SNF chains that have been selected to participate in this trial include Vetter, Nexion, 
Mission, and Genesis (Northeast facilities only). The intervention will be rolled out facility-wide. 
Participation occurs at 3 levels.  SNFs will be recruited and enrolled into the study.  Site 
administrators who agree to participate in the study will serve as gatekeepers within their facility. 
Direct care staff will agree to serve as Opinion Leaders. Residents within the facility are eligible 
if they qualify as long-stay (defined below).  
6.1 Facility inclusion criteria 
1) Among Genesis corporation, location in the Northeast (PA, NJ, CT, MA, RI, NH, 
VT, ME) AND at least 15% of residents identify as Black or Latinx. 
6.2 Facility exclusion criteria 
1) Evidence of institutional instability at time of recruitment 
2) Other reason (as determined by the SNF CEO) for inability to participate in the high 
touch intervention 
6.3 Resident inclusion criteria 
1) Long-stay will be defined as residence in the same facility for at least 100 days with no 
more than 10 days outside the facility on the date the first round of vaccines were delivered 
6.4  Resident exclusion criteria 
1) Living in the facility for less than 100 days  
2) Resident died/transferred during baseline and before the date the first vaccine was 
delivered to the facility 
6.5 Staff inclusion criteria 
1). Staff (i.e., nurses, care aids, dietary, and housekeeping) should provide care in the 
facility during the time of any of the vaccine clinics.  
6.6 Staff exclusion criteria 
1) Not a “usual” provider within the NH (i.e. visiting hospice provider) 
6.7  Study Enrollment Procedures  
All SNFs in the four chains are prepared to receive electronic messaging and educational 
material (i.e., usual care) through the American Health Care Association (AHCA). Within the 4 
SNF chains that have agreed to participate in the trial, we will ask the CEOs if there are any 
facilities that should be excluded due to leadership instability or other inability to participate in 
the  multi-pronged intervention. Remaining facilities will be randomized to additionally receive 
the  multi-pronged intervention versus continuing usual care.  
 

IMPACT-C Protocol v1.5 April 7, 2021 
7. STUDY INTERVENTIONS ADMINISTRATION AND DURATION 
The entire trial will take place over 11-15 weeks: each facility in the high touch intervention will 
be involved in approximately 1-3 week start up activities, 6-8 weeks of vaccine administration 
(three scheduled deliveries for vaccine approximately 3-4 weeks a part), and 4 weeks of data 
collection. Facilities in the usual care group will follow the same timeline for enrollment and 
data collection. During the start-up period in the high touch facilities, the research team works 
with the leadership and opinion leaders in each SNF to optimize program roll-out within each 
unique environment.   
7.1 Usual Care (Electronic Messaging and Education).  
All facilities affiliated with the AHCA and IMPACT Collaboratory (12 SNF chains with at least 
1,000 facilities) will be offered electronic messaging and education regarding the COVID-19 
vaccine. This material stems from the CDC and AMDA resources and represents a suggested 
approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., LARs, POAs). This 
electronic quality improvement material will be developed as part of a QI initiative and 
disseminated by AHCA to the SNF chains and using social media. Within the trial that includes 4 
of the 12 SNF chains, this will be considered ‘usual care’ in the control arm. Specific examples of 
electronic messaging and education include: 
a. Electronic Messaging – Direct care staff will be encouraged to post a selfie or short video 
encouraging others to get vaccinated. These messages will be disseminated through social 
media (e.g., Instagram). Messages will be linked with PSAs and FAQs regarding 
vaccination that reinforce the safety and efficacy of the vaccine. 
b. PSAs – Our research team, in conjunction with AHCA, will produce a series of short (2-5 
minute) video(s) designed to promote trust in the safety and efficacy of the SARS-CoV-2 
vaccine, particularly among Black and Latinx direct care workers. The videos will include 
direct care staff (NA and or floor nurse) giving a short testimonial about their experience 
with vaccination and promoting altruistic feelings about vaccination for the safety of 
others. If possible, we will include a short testimonial from a well-respected member of 
society specifically encouraging vaccination in SNF staff and residents. SNF leadership 
will encourage all staff to watch these videos during the start-up period as part of regularly 
scheduled team huddles/meetings or individually. In addition, these links will be provided 
to all proxies via letter or email, when they receive the FDA mandated Fact Sheet regarding 
the vaccine. 
c. FAQs- The AHCA will additionally disseminate suggested responses for frequently asked 
questions that staff and residents/proxies may have about the vaccine. This material has  
been reviewed by members of the National Association of Care Health Assistants 
(NACHA). SNF leadership will distribute these widely to staff during the start-up period. 
We will encourage SNFs to include the FAQ sheet to all proxies by letter or email as part 
of the material distributed with the vaccine Fact Sheet. 
 
7.2  HIGH TOUCH MULTI-PRONGED INTERVENTION 
Among four SNF chains, we will randomize eligible facilities to receive an additional “high touch” 
intervention. These high touch facilities will receive the electronic messaging and educational 
material described above. In addition these facilities will work with our research team on the 
following: 
 

IMPACT-C Protocol v1.5 April 7, 2021 
1. Facility Opinion Leader. At each intervention facility, our research team will work with 
the facility administration to identify local opinion leaders among nursing assistants 
(NA), nursing, dietary, and housekeeping. The opinion leaders will participate in the 
following activities: 1) Participate in an initial informational meeting with the research 
team and other facility opinion leaders; 2) Identify a local champion who could help 
participate in educational materials; 3) Participate in the social media messaging 
described in the Electronic Messaging section above; 4) Engage the research team for 
support and problem solving. 
We will invite all of the opinion leaders to participate in a one hour virtual informational 
meeting with members of our research team and other facility leaders. Meetings will be 
organized by discipline (e.g., nursing, dietary) and SNF chain. We will offer a few make-
up sessions for staff who are unable to attend.  During these meetings we will cover basic 
information on vaccine safety and efficacy, leaving the majority of time for an open 
question and answer session. These sessions will NOT be recorded. Opinion leaders who 
participate in these meetings will be given a $50 gift card for their time. 
Our research team will provide opinion leaders with direct contact information (email and 
phone number) of the study team so that they may ask questions during implementation. 
Insight Therapeutics will also work to identify a support team that can offer guidance and 
problem solve during implementation.  
2. Consenting Specialist. Through Insight Therapeutics, our research team will employ 
external staff members to facilitate the clinical consent for vaccination process. Each 
facility will make up to ten referrals of residents who were not vaccinated during the first 
of the three available vaccine dates to our consenting specialists.  Consenting specialists 
will contact each proxy, review risks and benefits of the vaccine, and answer questions. 
We will provide a 1-800 number for proxies who have additional questions/hesitancy, 
and we will offer a group zoom call for interested proxies to review risks and benefits. As 
indicated, this consenting process will be a clinical consent for the vaccination itself – not 
a study-specific informed consent process to participate in research.  We are seeking a 
waiver of informed consent for the overall intervention study. 
 
3. Building Trust Locally. The facility opinion leaders will be encouraged to identify well 
respected persons in the community (e.g., minister, teacher, government leader) who are 
willing to provide a message promoting trust in the vaccine. Through Insight 
Therapeutics, our research team will reach out to these leaders and coordinate the video 
messages and implementation plan.  Messages will be distributed widely within a facility 
by email, website, text and/or social media. Further, our research team will prepare the 
community leaders to serve as an additional support for the facility opinion leaders 
during implementation.  
4. Positive Reinforcement. Our research team will create and distribute buttons, T-shirts, 
and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 
vaccine! OR Vaccinated for You!). These items will be distributed through facility 
leadership at each facility, with recommendations to give each staff member these 
goodies when vaccinated. 
 

IMPACT-C Protocol v1.5 April 7, 2021 
5. Testing Supplies. Our research team will provide funds ($10,000) to each facility in the 
high touch intervention arm, that the facility may use to acquire additional COVID-19 
testing kits. This will enable frequent testing of any residents and staff that experience 
symptoms following vaccination. Given that the cost of most point-of-care testing kits is 
around $50, these funds will support the cost of approximately 200 test kits. We will 
suggest that facilities follow the CDC recommendations for testing following 
vaccination.[28, 29] Our research team will additionally facilitate kits for facilities that 
are experiencing difficulty securing the test kits.  
.  
The high touch intervention will be implemented in two waves. For the first cycle of vaccine 
administration we will focus on identifying opinion leaders and positive reinforcement. During 
the second round we will add building trust locally, a consenting specialist, and testing supplies.  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
8. DATA COLLECTION ELEMENTS AND PROTOCOL  
8.1 Facility Data 
Nursing home data are collected prior to the start of the study for descriptive purposes and to 
inform the development of a list of eligible facilities for recruitment. These include elements 
from Nursing Home Compare, including: the number of beds, hospital-based, special care 
dementia unit, nursing and nursing assistant hours/resident/day, and number of deficiencies on 
state inspections.  
 
8.2 Resident Data 
Resident data is already being collected for all facilities within the 4 chains as part of the RADx-
UP supplement. Existing data transfer agreements from all 4 chains have been signed and 
authorized. We plan to use data from the electronic medical record, as well as data from the 
Minimum Data Set (MDS) for this study. Resident characteristics will be obtained during 
baseline only (that is during the 3 months before the vaccine is first delivered to the facility) 
whereas vaccination data will be obtained during the 6-8 weeks of implementation and 4 weeks 
of followup.. 
Demographic:  age, gender, race, ethnicity, proxy contact information (for “high touch” facilities 
only in need of consenting specialist) and relationship to resident.  
 
Medical co-morbidity: All active medical diagnoses. History of COVID-19 infection from 
testing results and diagnoses in EMR.  
Functional status: Katz Activities of Daily Living Scale from MDS; Dementia severity 
(Cognitive Functional Scale) 
 
Influenza Vaccination: Using EMR and MDS data we will also determine if each resident 
received the influenza vaccine during the 2020-2021 season 
SARS-CoV-2 Vaccination: Using the EMR we will determine if each resident received any dose 
of the SARS-CoV-2 vaccine within the vaccine implementation period and 4 weeks from the last 
date the vaccine was delivered to the facility.  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
8.3. Staff data  
Each facility will provide our team with a log of aggregated staff vaccination (counts of number 
of staff vaccinated). We will calculate the number of eligible staff in a facility using the Kronos 
time and effort reports along with Payroll-Based Journal data. 
For Genesis facility only, we will receive additional person level information on staff 
demographics (job description, race/ethnicity) from Human Resources.  
In addition, the facility opinion leaders will be surveyed with regards to their experience of the 
intervention components. This anonymous data will be collected via a Qualtrics survey sent 
directly to all opinion leaders.  
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
9. STATISTICAL ANALYSIS 
 
9.1 General Design: The hypothesis that will be tested is whether facilities that receive the high 
touch multi-pronged intervention will achieve a greater number of staff and residents 
vaccinated as compared with facilities randomized to usual care.  
 
9.2 Sample Size and Randomization:  
 
9.3 Outcomes 
 
Primary Outcome – The primary outcome will be a binary measure (Yes or No) indicating 
whether an eligible resident received any doses of the vaccine during the study period. 
 
Secondary Outcome – The secondary outcome will be the number of staff that received any dose 
of the vaccine during the study period. This will be the count of all eligible staff who received 
one or more doses of the vaccine.  
 
We will examine the primary outcome separately by race/ethnicity (defined as White, Black, 
Latinx, and Other). In one SNF chain (Genesis) we will examine the secondary outcome 
separately by race/ethnicity. 
 
9.4 Approach   
The treatment effect based on the primary binary outcome will be the estimated odds ratio (OR). 
The primary outcome will be analyzed at the individual resident level using a mixed effects 
generalized linear model with a binomial distribution that includes both network fixed effects, 
race/ethnicity strata-specific fixed effects as well as nursing home-specific random effects: 
 
𝑙𝑙𝑙𝑙𝑙𝑙ቆ
𝑃𝑃(𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖= 1)
1 −𝑃𝑃(𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖= 1)ቇ= 𝛽𝛽0 + 𝛽𝛽1𝑇𝑇𝑗𝑗𝑗𝑗+ 𝛽𝛽2(𝑆𝑆𝑗𝑗𝑗𝑗= 2) + 𝛽𝛽3(𝑆𝑆𝑗𝑗𝑗𝑗= 3) + 𝛼𝛼𝑘𝑘+ 𝑏𝑏𝑗𝑗𝑗𝑗 , 
 
where 𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖 is an indicator variable for resident i in nursing home j/network k, where 𝑘𝑘∈
 (1, 2, 3, 4); 𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖= 1 if the resident received the vaccine and 𝑌𝑌𝑖𝑖𝑖𝑖𝑖𝑖= 0 otherwise. 𝑇𝑇𝑗𝑗𝑗𝑗 is an 
indicator variable for nursing home j/network k; 𝑇𝑇𝑗𝑗𝑗𝑗= 1 if the nursing home is in the 
intervention arm and 𝑇𝑇𝑗𝑗𝑗𝑗= 0 if in the control arm. 𝑆𝑆𝑗𝑗𝑗𝑗 is the strata indicator, 𝑆𝑆𝑗𝑗𝑗𝑗∈ (1, 2, 3).  𝛼𝛼𝑘𝑘 
is the network-specific fixed effect for network k. 𝑏𝑏𝑗𝑗 is the nursing home-specific random effect, 
which has a normal distribution with mean 0 and standard deviation 𝜎𝜎𝑏𝑏. The parameter 𝛽𝛽1is the 
log-OR of vaccination, comparing the odds of vaccination for those in the intervention arm with 
the odds of vaccination for those in the control arm.  
 
We will estimate an odds ratio (𝛽𝛽̂1) along with a 95% confidence interval. We will conduct a 
two-sided hypothesis test based on 𝐻𝐻0: 𝛽𝛽1 = 0 𝑣𝑣𝑣𝑣. 𝐻𝐻1: 𝛽𝛽1 ≠0 using an 𝛼𝛼-level 0.05. All analyses 
will be conducted using the latest version of R (currently 4.0.3, R Foundation for Statistical 
Computing, Vienna, Austria). 
 

IMPACT-C Protocol v1.5 April 7, 2021 
We will use an intention-to-treat approach as our primary analytic approach, including all 
facilities that were randomized to the intervention regardless of implementation of the 
intervention components. Additional exploratory analyses will estimate a complier average 
causal effect to assess the effect of the intervention on those SNFs who fully engage in the 
intervention.  
Because the components of the “high touch” intervention will be rolled out sequentially in waves 
(e.g., first facility champion and positive reinforcement, then building local trust, consenting 
specialist and additional testing supplies) we will examine the individual and additive effects of 
program components, if possible. 
 
A similar approach will be used to determine the effect of the high touch intervention on staff 
vaccination. 
 
The logistic model described for the primary analysis will be extended to include race and 
ethnicity indicators as well as interaction terms, to better understand if the treatment effect is 
heterogeneous across different subgroups of residents. 
 
9.5 POWER ESTIMATE 
Using the crtpwr.2prop function in the R package clusterPower (version 0.6.111), we estimate 
that with 60 facilities in the intervention group, we will have 90% power to observe a difference 
of 10 percentage points and 80% power to observe a difference of 8 percentage points, under the 
assumption that the probability of vaccination is 70% in the intervention facilities, an intraclass 
correlation of 0.05, and average cluster size of 60. This is likely a conservative estimate of the 
intraclass correlation, and we will have 80% power to observe a difference of just 6 percentage 
points if the intraclass correlation is 0.02 and other assumptions remain unchanged (see Figure). 
 

IMPACT-C Protocol v1.5 April 7, 2021 
 
10. HUMAN SUBJECT PROTECTIONS 
10.1 Sources of Data 
Resident EMR: The residents’ EMR medical is already being transferred at regular intervals to 
secure servers at Brown University as part of this RADx-UP supplement. This will include 
information the information regarding vaccination and history of COVID-19 infection.  
Minimum Data Set: We already have DUAs in place to allow use of MDS data for all 12 SNF 
chains. This will be used to provide descriptive information about residents in the trial. 
Facility logs: Facilities will provide staff COVID-19 vaccination logs (binary counts of the 
number of staff vaccinated). 
Kronos and time and effort reporting: We already have data transfer agreements in place for 
Kronos, and we will be using this data to identify the number of eligible staff in each facility.  
Payroll-Based Journal data: This publicly available dataset via the Centers for Medicare and 
Medicaid Services will provide staffing estimates from total hours worked per day for all study 
facilities. 
Genesis Human Resources Data: We already have data transfer agreements in place to share 
demographic information on staff within the Genesis facility, including age, length of time of 
employment, and race/ethnicity. 
Proxy name and contact: In the intervention homes only, our study team and credentialing 
specialists (through Insight Therapeutics) will receive referrals with the name, contact number 
and relationship of proxies who have not responded to the electronic informed consent request in 
the first round of vaccination. This information will be stored securely either in locked cabinets 
or behind a secure server and will NOT be distributed or used in any of the analysis.  
Opinion leader survey data: We will collect anonymous data from opinion leaders via a Qualtrics 
survey that will examined at an aggregate level. The information will be stored securely via a 
secured server. 
11. POTENTIAL RISKS OF STUDY PROCEDURES 
The study meets criteria for minimal risk. Our intervention to reduce vaccine hesitancy is based 
on suggestions from experts and recommendations from leading organizations, the risk of harm 
is low.  
We will request both a waiver of informed consent under the Common Rule and a HIPAA 
waiver of authorization under the HIPAA Privacy Act for resident and staff participation in this 
study. 
11.1 Potential Medical Risk to Study Participants 
Data from the Pfizer vaccine Phase III studies suggests that the risk of adverse events from 
vaccination is low, even in residents over the age of 65.[8] The most common side effects are 
arm pain, followed by fatigue, headache, chills and fever.  Although side effects of the vaccine 

IMPACT-C Protocol v1.5 April 7, 2021 
itself are not directly related to our intervention, we do plan to collect and report information on 
adverse events among residents in all facilities (see description below).  
We do not anticipate any potential psycho-social risks discomforts or inconveniences of study 
procedures beyond those encountered in usual care practices.  The intervention provides 
information for proxies and staff about the safety and efficacy of the vaccine. The intervention 
will be rolled out at a facility level. Staff and proxies do not have to view any of the electronic 
material or participate in any training sessions that we will provide.  
 
The risk of loss of confidentiality is low. Our team is already collecting this data as part of 
existing data transfer agreements with provisions to keep identifiable data safe. Staff who 
participate in the Opinion Leader training sessions will need to provide their name and facility, in 
order to receive reimbursement with an e-gift card. This list of names will be kept behind a 
secure server and will NOT be distributed or used in any of the analysis. The consenting 
specialists will receive referrals with confidential information including patient and proxy name. 
This information will be kept behind a secure server and will NOT be distributed or used in any 
of the analyses. 
 
One additional potential burden of this study is the time commitment of the SNF staff in to 
address questions raised by the electronic material we will provide. We will provide staff will a 
list of FAQs that may be helpful. In addition, for the intervention facilities we will offer some 
training and support for facility opinion leaders.  
 
11.3 Adverse Events and Serious Adverse Events  
This is a study to reduce vaccine hesitancy and we do not anticipate any study related adverse 
events to occur in this study. Separately, members of our team are monitoring adverse side 
effects of the vaccine in residents within one SNF chain (Genesis).  
 
AE/SAE Definitions:  
The study will adhere to the definitions for AEs and SAEs stipulated in the NIA Adverse Event 
and Serious Adverse Event Guidelines as outlined below.  
 
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study 
participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the participants’ involvement in the research, 
whether or not considered related to participation in the research.  
 
 
 
SAE Definition: SAEs consist of any adverse event that results in death; requires 
hospitalization; or anaphylaxis/ meets the Centers for Disease Control definition of serious 
adverse events potentially associated with the vaccine (CDC weblink) 
Reporting Procedures 

IMPACT-C Protocol v1.5 April 7, 2021 
The study team will collect information on SAEs (deaths, hospitalizations, and CDC defined 
potential serious related adverse events) among residents using the Electronic Medical Records 
(EMR). This information is sent securely to Brown University from some facility daily, for other 
data is transmitted weekly or monthly. 
We propose the following reporting schedule for AEs and SAEs: 
• All adverse events that are both serious (SAE) and unexpected (i.e., have not been 
previously reported for the study's intervention) should be reported to the IRB, NIA PO and 
to the NIA-Appointed Safety Officer (SO) within 48 hours of the study's knowledge of 
SAE.  
• The summary of all other SAEs should be reported to NIA PO and to the SO along with 
recruitment and retention milestones, quarterly (unless otherwise requested by the SO). The 
SO will make recommendations to the DSMB and the NIA 
PO particularly regarding the related SAEs and recruitment and retention milestones.  
Expected SAEs unrelated to the trial intervention are listed in DSMP and include death, 
hospitalization, and vaccine-related adverse reactions as per CDC (i.e., anaphylaxis). There 
are no expected SAEs related to the trial intervention which aims to reduce vaccine 
hesitancy. 
• The DSMB provides overall data and safety monitoring oversight for the study and makes 
recommendation to the NIA regarding study continuation.  
• 
All deaths will be reported to the Safety Officer, IMPACT-C Collaboratory Regulatory and 
Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. 
Partha Bhattacharya) within 24 hours of study’s knowledge of death.  
• AEs will be reported per IRB policies and also to IMPACT Collaboratory Regulatory and 
Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. 
Partha Bhattacharya), and the IMPACT Collaboratory DSMB Chair (or the project’s Safety 
Officer at minimum every 6 months, or at a frequency requested by NIA and/or by the 
DSMB.  
 
11.2 Safety Monitoring 
As agreed upon by the NIA and overseeing project officer, Dr. Partha Bhattacharyya, safety 
monitoring will be the responsibility of a Data Safety Monitor (DSM). Additionally, the project 
officer will appoint a Safety Officer. Given the urgent need to begin this study immediately, we 
will review any issues raised by the data safety monitoring officer simultaneously with IRB 
review. Similarly, given the very short timeline for vaccine administration in SNFs, we will not 
plan an interim DSM meeting, but we will provide the project officer and SO the SAE reports 
quarterly, or sooner if available, and they will notify DSMB of related SAEs.   The DSM may 
determine the need to stop the continuation of the study based on examination of these reports. 
12. INTERVENTION DISCONTINUATION  
The study may be discontinued at any time by the IRB, the NIA, OHRP or other government 
agencies as part of their duties to ensure that research participants are protected. Individual SNFs 
in the intervention arm may withdraw from study participation at any time at the discretion of 
their senior management or corporate supervisors. Staff and proxies or residents can opt out of 

IMPACT-C Protocol v1.5 April 7, 2021 
viewing any of the electronic material we will provide.  Facilities may choose to implement only 
some of the intervention. Variation in implementation is expected in clinical practice and as part 
of this pragmatic trial. 
 
 

IMPACT-C Protocol v1.5 April 7, 2021 
13. REFERENCES 
1. 
Abbasi, J., "Abandoned" Nursing Homes Continue to Face Critical Supply and Staff 
Shortages as COVID-19 Toll Has Mounted. JAMA, 2020. 
2. 
McGarry BE, P.L., Grabowski DC., Nursing Home Workers Now Have the Most 
Dangerous Jobs in America. They Deserve Better. in Washington Post. 2020. 
3. 
Services, C.f.M.M. COVID-19 Nursing Home Data. 2020  [cited 2020 June 30]; 
Available from: https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-
xpvg. 
4. 
Amir, O., et al., Incidence of hip fracture in Native American residents of U.S. nursing 
homes. Bone, 2019. 123: p. 204-210. 
5. 
Cai, S., et al., Despite small improvement, black nursing home residents remain less 
likely than whites to receive flu vaccine. Health Aff (Millwood), 2011. 30(10): p. 1939-
46. 
6. 
Hausmann, L.R., et al., Racial and ethnic disparities in pneumonia treatment and 
mortality. Med Care, 2009. 47(9): p. 1009-17. 
7. 
Werner, R.M., A.K. Hoffman, and N.B. Coe, Long-Term Care Policy after Covid-19 - 
Solving the Nursing Home Crisis. N Engl J Med, 2020. 
8. 
Polack, F.P., et al., Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N 
Engl J Med, 2020. 
9. 
COVID Collaborative Survey: Coronavirus Vaccination Hesitancy in the Black and 
Latinx Communities L.R. Associates, Editor. 2020. 
10. 
Daugherty, J.D., et al., Influenza vaccination rates and beliefs about vaccination among 
nursing home employees. Am J Infect Control, 2015. 43(2): p. 100-6. 
11. 
Foundation, K.F. COVID019 and Workers at Risk: examing the Long-Term Care 
workforce. 2020  [cited 2020 July 10]; Available from: 
https://www.ahcancal.org/News/news_releases/Documents/AHCA-NCAL-Survey-
Testing-Results.pdf. 
12. 
PHI. Quality Care through Quality Jobs. 2020  [cited 2020 July 10]; Available from: 
https://www.ahcancal.org/News/news_releases/Documents/AHCA-NCAL-Survey-
Testing-Results.pdf. 
13. 
Porter, L., National Association of Health Care Assistants (NACHA). 2020. 
14. 
McGarry, B.E., et al., COVID-19 Test Result Turnaround Time for Residents and Staff in 
US Nursing Homes. JAMA Intern Med, 2020. 
15. 
Bardenheier, B., et al., Racial inequities in receipt of influenza vaccination among long-
term care residents within and between facilities in Michigan. Med Care, 2011. 49(4): p. 
371-7. 
16. 
Bardenheier, B.H., et al., Persistence of Racial Inequities in Receipt of Influenza 
Vaccination among Nursing Home Residents in the United States. Clin Infect Dis, 2020. 
17. 
Gravenstein, S., et al., Feasibility of a cluster-randomized influenza vaccination trial in 
U.S. nursing homes: Lessons learned. Hum Vaccin Immunother, 2018. 14(3): p. 736-743. 
18. 
Gravenstein, S., et al., Comparative effectiveness of high-dose versus standard-dose 
influenza vaccination on numbers of US nursing home residents admitted to hospital: a 
cluster-randomised trial. Lancet Respir Med, 2017. 5(9): p. 738-746. 
19. 
Mitchell, S.L., et al., An Advance Care Planning Video Decision Support Tool for 
Nursing Home Residents With Advanced Dementia: A Cluster Randomized Clinical Trial. 
JAMA Intern Med, 2018. 178(7): p. 961-969. 

IMPACT-C Protocol v1.5 April 7, 2021 
20. 
Rashid, H., et al., Assessing Interventions To Improve Influenza Vaccine Uptake Among 
Health Care Workers. Health Aff (Millwood), 2016. 35(2): p. 284-92. 
21. 
Heffner, J., M.L. Vives, and O. FeldmanHall, Emotional responses to prosocial messages 
increase willingness to self-isolate during the COVID-19 pandemic. Pers Individ Dif, 
2021. 170: p. 110420. 
22. 
Lytras, T., et al., Interventions to increase seasonal influenza vaccine coverage in 
healthcare workers: A systematic review and meta-regression analysis. Hum Vaccin 
Immunother, 2016. 12(3): p. 671-81. 
23. 
Loomer, L., et al., Nursing Home Characteristics Associated With Implementation of an 
Advance Care Planning Video Intervention. J Am Med Dir Assoc, 2019. 20(7): p. 804-
809 e1. 
24. 
Palmer, J.A., et al., Barriers and facilitators to implementing a pragmatic trial to 
improve advance care planning in the nursing home setting. BMC Health Serv Res, 
2019. 19(1): p. 527. 
25. 
Chambers, L.W., et al., A new approach to improving healthcare personnel influenza 
immunization programs: a randomized controlled trial. PLoS One, 2015. 10(3): p. 
e0118368. 
26. 
Gilmore, B., et al., Community engagement for COVID-19 prevention and control: a 
rapid evidence synthesis. BMJ Glob Health, 2020. 5(10). 
27. 
Chou, W.S. and A. Budenz, Considering Emotion in COVID-19 Vaccine 
Communication: Addressing Vaccine Hesitancy and Fostering Vaccine Confidence. 
Health Commun, 2020. 35(14): p. 1718-1722. 
28. 
CDC. Post Vaccine Considerations for Healthcare Personnel. 2020  [cited 2020 
December 15]; Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-
vaccine-considerations-healthcare-personnel.html. 
29. 
CDC. Post Vaccine Considerations for Nursing Home Residents. 2020  [cited 2020 
December 15]; Available from:  
https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-residents.html.