Improving COVID-19 Vaccine Uptake in Nursing Homes

An IRB waiver of consent was obtained for this study. The investigators 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
skilled nursing facility (SNF) staff and residents among a random sample of facilities across
four SNF chains. This will be a cluster randomized trial where the intervention is applied at
the facility level. The 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 four SNF chains that have been selected have already given assent to participate in this
trial. The facilities will then be stratified 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. A
total of 60 SNFs will be randomized 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. 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, the
lead statistician, and programmers will be masked.

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
four SNF chains that have agreed to participate in the trial, the investigators 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.

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.

Among four SNF chains, the research team 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 the research team on the following:

1. Facility Opinion Leader. At each intervention facility, the 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.

The research team will invite all of the opinion leaders to participate in a one hour
virtual informational meeting with members of the research team and other facility
leaders. Meetings will be organized by discipline (e.g., nursing, dietary) and SNF
chain. The research team will offer a few make-up sessions for staff who are unable to
attend. During these meetings, basic information on vaccine safety and efficacy will be
covered, 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 gift card for their time.

Our research team will provide opinion leaders with direct contact information (email
and phone number) of the research 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, the 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 the consenting specialists. Consenting
specialists will contact each proxy, review risks and benefits of the vaccine, and
answer questions. The research team will provide a 1-800 number for proxies who have
additional questions/hesitancy and 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. The investigators received 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, the 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, the research team will prepare the
community leaders to serve as an additional support for the facility opinion leaders
during implementation.

4. Positive Reinforcement. The 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.

5. Testing Supplies. The research team will provide funds 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 the cost of most point-of-care testing kits, these
funds will support the cost of approximately 200 test kits. The research team will
suggest that facilities follow the CDC recommendations for testing following
vaccination. The 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. The first cycle of vaccine
administration, the research team will focus on identifying opinion leaders and positive
reinforcement. During the second round, the research team will add building trust locally, a
consenting specialist, and testing supplies.

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.

Resident data is already being collected for all facilities within the four chains as part of
the RADx-UP supplement. Existing data transfer agreements from all four chains have been
signed and authorized. The research team plans 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 follow-up. Resident and outcome data will be
aggregated at the level of the facility.

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. The research team will use an
intention-to-treat approach as the 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. 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.