Trial Outcomes & Findings for Improving COVID-19 Vaccine Uptake in Nursing Homes (NCT NCT04732819)
NCT ID: NCT04732819
Last Updated: 2021-09-05
Results Overview
A binary measure (Yes or No) indicating whether a long stay nursing home resident received any dose of a SARS-CoV-2 vaccine, identified by the electronic medical records (EMR) within the study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23768 participants
Primary outcome timeframe
15 weeks
Results posted on
2021-09-05
Participant Flow
We first identified 154 facilities within 4 nursing home chains that were eligible to participate in the trial. After talking with corporate leadership in the four chains, we excluded 21 facilities with institutional instability. This left us with 133 facilities for randomization and a total of 23,768 staff and residents across all facilities (16,272 staff and 7,496 residents).
Unit of analysis: Nursing home facility
Participant milestones
| Measure |
Usual Care
Staff and residents in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
|
High Touch
Staff and residents in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:
1. Identify and engage a Facility Opinion Leader.
2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
5. Acquire additional COVID-19 testing kits using funds provided by our research team.
|
|---|---|---|
|
Overall Study
STARTED
|
12582 70
|
11186 63
|
|
Overall Study
COMPLETED
|
12582 70
|
11186 63
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving COVID-19 Vaccine Uptake in Nursing Homes
Baseline characteristics by cohort
| Measure |
Usual Care
n=70 Nursing home facility
Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
|
High Touch
n=63 Nursing home facility
Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:
1. Identify and engage a Facility Opinion Leader.
2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
5. Acquire additional COVID-19 testing kits using funds provided by our research team.
|
Total
n=133 Nursing home facility
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 (residents)
|
789 Participants
n=5 Participants
|
758 Participants
n=7 Participants
|
1547 Participants
n=5 Participants
|
|
Age, Customized
65-69 (residents)
|
455 Participants
n=5 Participants
|
415 Participants
n=7 Participants
|
870 Participants
n=5 Participants
|
|
Age, Customized
70-74 (residents)
|
479 Participants
n=5 Participants
|
453 Participants
n=7 Participants
|
932 Participants
n=5 Participants
|
|
Age, Customized
75-79 (residents)
|
473 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
915 Participants
n=5 Participants
|
|
Age, Customized
80-84 (residents)
|
506 Participants
n=5 Participants
|
441 Participants
n=7 Participants
|
947 Participants
n=5 Participants
|
|
Age, Customized
85-89 (residents)
|
537 Participants
n=5 Participants
|
492 Participants
n=7 Participants
|
1029 Participants
n=5 Participants
|
|
Age, Customized
90+ (residents)
|
594 Participants
n=5 Participants
|
618 Participants
n=7 Participants
|
1212 Participants
n=5 Participants
|
|
Age, Customized
Missing (residents)
|
32 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Customized
Missing (staff)
|
8717 Participants
n=5 Participants
|
7555 Participants
n=7 Participants
|
16272 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female (residents)
|
2354 Participants
n=5 Participants
|
2283 Participants
n=7 Participants
|
4637 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male (residents)
|
1474 Participants
n=5 Participants
|
1328 Participants
n=7 Participants
|
2802 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing (residents)
|
37 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing (staff)
|
8717 Participants
n=5 Participants
|
7555 Participants
n=7 Participants
|
16272 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3715 Participants
n=5 Participants
|
3484 Participants
n=7 Participants
|
7199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8754 Participants
n=5 Participants
|
7575 Participants
n=7 Participants
|
16329 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1020 Participants
n=5 Participants
|
953 Participants
n=7 Participants
|
1973 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2588 Participants
n=5 Participants
|
2427 Participants
n=7 Participants
|
5015 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8974 Participants
n=5 Participants
|
7806 Participants
n=7 Participants
|
16780 Participants
n=5 Participants
|
|
Average Number of Beds
|
110 Beds
STANDARD_DEVIATION 54.7 • n=70 Nursing home facility
|
114 Beds
STANDARD_DEVIATION 56.6 • n=63 Nursing home facility
|
112 Beds
STANDARD_DEVIATION 55.4 • n=133 Nursing home facility
|
|
Number of Nursing Home Facilities with Alzheimer's Units
|
13 Nursing home facility
n=70 Nursing home facility
|
9 Nursing home facility
n=63 Nursing home facility
|
22 Nursing home facility
n=133 Nursing home facility
|
|
Number of For Profit Nursing Home Facilities
|
48 Nursing home facility
n=70 Nursing home facility
|
47 Nursing home facility
n=63 Nursing home facility
|
95 Nursing home facility
n=133 Nursing home facility
|
PRIMARY outcome
Timeframe: 15 weeksPopulation: Total number of long-stay residents in the nursing homes at the time of the first of three vaccine clinics.
A binary measure (Yes or No) indicating whether a long stay nursing home resident received any dose of a SARS-CoV-2 vaccine, identified by the electronic medical records (EMR) within the study period.
Outcome measures
| Measure |
Usual Care
n=3865 Participants
Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
|
High Touch
n=3631 Participants
Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:
1. Identify and engage a Facility Opinion Leader.
2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
5. Acquire additional COVID-19 testing kits using funds provided by our research team.
|
|---|---|---|
|
Number of Residents Who Received SARS-CoV-2 Vaccine
|
3083 Participants
|
2994 Participants
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: Number of staff was estimated using the total number of unique staff identified in these facilities with PBJ (payroll based journal) data averaged over the last two quarters of 2020.
A binary measure (Yes or No) indicating whether a staff member received any dose of a SARS-CoV-2 vaccine, identified by the facility log within the study period.
Outcome measures
| Measure |
Usual Care
n=8716 Participants
Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
|
High Touch
n=7555 Participants
Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:
1. Identify and engage a Facility Opinion Leader.
2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
5. Acquire additional COVID-19 testing kits using funds provided by our research team.
|
|---|---|---|
|
Number of Staff Who Received SARS-CoV-2 Vaccine
|
4643 Participants
|
4098 Participants
|
Adverse Events
Usual Care
Serious events: 158 serious events
Other events: 0 other events
Deaths: 259 deaths
High Touch
Serious events: 179 serious events
Other events: 0 other events
Deaths: 224 deaths
Serious adverse events
| Measure |
Usual Care
n=3865 participants at risk
Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
|
High Touch
n=3631 participants at risk
Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
High touch multi-pronged behavioral intervention: In this intervention, facilities will work with our research team to accomplish the following:
1. Identify and engage a Facility Opinion Leader.
2. Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
3. Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
4. Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
5. Acquire additional COVID-19 testing kits using funds provided by our research team.
|
|---|---|---|
|
General disorders
All-Cause Hospitalizations
|
4.1%
158/3865 • Adverse event data was collected from the date of the first vaccine clinic until the date of the last vaccine clinic, up to 15 weeks.
The number of participants here represent the number of residents in each arm. Adverse event information was collected on residents but not staff.
|
4.9%
179/3631 • Adverse event data was collected from the date of the first vaccine clinic until the date of the last vaccine clinic, up to 15 weeks.
The number of participants here represent the number of residents in each arm. Adverse event information was collected on residents but not staff.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place