N/A
N=23,768
Improving COVID-19 Vaccine Uptake in Nursing Homes
COVID-19 Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT04732819 ↗Enrolled (actual)
23,768
Serious AEs
4.5%
Results posted
Sep 2021
Primary outcome: Primary: Number of Residents Who Received SARS-CoV-2 Vaccine — 3083; 2994 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High touch multi-pronged behavioral intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Residents Who Received SARS-CoV-2 Vaccine |
3083; 2994 | — |
| SECONDARY Number of Staff Who Received SARS-CoV-2 Vaccine |
4643; 4098 | — |
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.
Eligibility Criteria
Inclusion criteria
- Residents: Long-stay residents who have been in one of our participating skilled nursing facilities (SNFs) for at least 100 days and who are alive on the date that the first round of vaccines is available.
- Staff: Staff providing care in one of our participating skilled nursing facilities during the vaccine clinics.
Exclusion criteria
- Facilities: Facilities with evidence of institutional instability at time of recruitment or otherwise determined by the SNF CEO to be unable to participate in the high touch intervention.
- Residents: Residents who have been in one of our participating SNFs for less than 100 days or who died or were transferred before the date the first vaccine was delivered to the facility.
- Staff: Staff who are not a "usual" provider within the SNF (for instance, a visiting hospice provider).
Data sourced from ClinicalTrials.gov (NCT04732819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.