Improving COVID-19 Vaccine Uptake in Nursing Homes

NCT04732819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23768

Last updated 2021-09-05

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732819 on ClinicalTrials.gov