Evaluating the Findings of the IMPACT-C Randomized Clinical Trial to Improve COVID-19 Vaccine Coverage in Skilled Nursing Facilities

Abstract

Importance: Identifying successful strategies to increase COVID-19 vaccination among skilled nursing facility (SNF) residents and staff is integral to preventing future outbreaks in a continually overwhelmed system.

Objective: To determine whether a multicomponent vaccine campaign would increase vaccine rates among SNF residents and staff.

Design, setting, and participants: This was a cluster randomized trial with a rapid timeline (December 2020-March 2021) coinciding with the Pharmacy Partnership Program (PPP). It included 133 SNFs in 4 health care systems across 16 states: 63 and 70 facilities in the intervention and control arms, respectively, and participants included 7496 long-stay residents (>100 days) and 17 963 staff.

Interventions: Multicomponent interventions were introduced at the facility level that included: (1) educational material and electronic messaging for staff; (2) town hall meetings with frontline staff (nurses, nurse aides, dietary, housekeeping); (3) messaging from community leaders; (4) gifts (eg, T-shirts) with socially concerned messaging; (5) use of a specialist to facilitate consent with residents' proxies; and (6) funds for additional COVID-19 testing of staff/residents.

Main outcomes and measures: The primary outcomes of this study were the proportion of residents (from electronic medical records) and staff (from facility logs) who received a COVID-19 vaccine (any), examined as 2 separate outcomes. Mixed-effects generalized linear models with a binomial distribution were used to compare outcomes between arms, using intent-to-treat approach. Race was examined as an effect modifier in the resident outcome model.

Results: Most facilities were for-profit (95; 71.4%), and 1973 (26.3%) of residents were Black. Among residents, 82.5% (95% CI, 81.2%-83.7%) were vaccinated in the intervention arm, compared with 79.8% (95% CI, 78.5%-81.0%) in the usual care arm (marginal difference 0.8%; 95% CI, -1.9% to 3.7%). Among staff, 49.5% (95% CI, 48.4%-50.6%) were vaccinated in the intervention arm, compared with 47.9% (95% CI, 46.9%-48.9%) in usual care arm (marginal difference: -0.4%; 95% CI, -4.2% to 3.1%). There was no association of race with the outcome among residents.

Conclusions and relevance: A multicomponent vaccine campaign did not have a significant effect on vaccination rates among SNF residents or staff. Among residents, vaccination rates were high. However, half the staff remained unvaccinated despite these efforts. Vaccination campaigns to target SNF staff will likely need to use additional approaches.

Trial registration: ClinicalTrials.gov Identifier: NCT04732819.

Conflict of interest statement

Conflict of Interest Disclosures: Dr McConeghy reported grants from Sanofi-Pasteur, Seqirus Pharmaceuticals, and Pfizer outside the submitted work. Dr Gifford reported grants from Brown University during the conduct of the study; grants from the Centers for Disease Control and from Brown University outside the submitted work; as well as work for the American Health Care Association. Dr Davidson reported grants from Brown University related to IMPACT-C during the conduct of the study and grants from Sanofi Research and Seqirus Research outside the submitted work. Dr Han reported grants from Brown University during the conduct of the study and grants from Sanofi Pasteur and Vaccine research outside the submitted work. Dr Gandhi reported grants from the National Institute for Health Care Management, the Washington Center for Equitable Growth, and the University of California Los Angeles outside the submitted work. Dr Gravenstein reported grants from Seqirus, Sanofi, and Pfizer, and personal fees from Janssen, Novavax, Merck, Seqirus, Sanofi, Vaxart, and Pfizer outside the submitted work. Dr Mor reported personal fees from naviHealth outside the submitted work. No other disclosures were reported.

Figures

Figure.. CONSORT Diagram Describing Selection of Intervention and Usual Care Facilities, Residents, and Staff in the IMPACT-C Trial

SNF indicates skilled nursing facility. aInstitutional instability was defined by asking the leaders of the 4 health care systems to identify any facilities that were likely to be divested within the next 3 months. bLong stay indicates a nursing home stay that was greater than or equal to 100 days as of the date of the first vaccine clinic.