Improving COVID-19 Vaccine Uptake in Nursing Homes
NCT04732819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23768
Last updated 2021-09-05
Summary
SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators 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.
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 staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators 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 four 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.
The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs 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; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.
Conditions
- COVID-19 Vaccines
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
Hebrew SeniorLife
collaborator OTHER -
Insight Therapeutics, LLC
collaborator OTHER -
New York University
collaborator OTHER -
Brown University
lead OTHER
Principal Investigators
-
Sarah D Berry, MD, MPH · Hebrew SeniorLife
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-21
- Primary Completion
- 2021-03-31
- Completion
- 2021-04-16
Countries
- United States
Study Locations
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