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

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  Does a multicomponent vaccine campaign increase COVID-19 vaccination rates among residents and staff in skilled nursing facilities (SNFs)?

Findings  In this randomized clinical trial of 133 SNFs that included 7496 residents and 17 963 staff, 81.1% of residents and 53.7% of staff were vaccinated. The 3-month-long campaign leveraged best practices for encouraging vaccination such as identifying frontline champions and giving small gifts to vaccinated staff; there was no significant difference in resident or staff vaccination in facilities that received the vaccine campaign vs usual care.

Meaning  Multicomponent interventions offered as a bundle may not be enough to increase COVID-19 vaccine rates in the SNF setting.

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

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: October 8, 2021.

Published Online: January 31, 2022. doi:10.1001/jamainternmed.2021.8067

Corresponding Author: Sarah D. Berry, MD, MPH, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA 02131 (sarahberry@hsl.harvard.edu).

Author Contributions: Drs Goldfeld and McConeghy had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Berry, Goldfeld, McConeghy, Gifford, Davidson, Han, Syme, Harrison, Recker, Johnson, Gravenstein, Mor.

Acquisition, analysis, or interpretation of data: Berry, McConeghy, Gifford, Davidson, Han, Gandhi, Mitchell, Harrison, Recker, Johnson, Gravenstein, Mor.

Drafting of the manuscript: Berry, Gifford, Mitchell, Harrison.

Critical revision of the manuscript for important intellectual content: Goldfeld, McConeghy, Davidson, Han, Syme, Gandhi, Mitchell, Harrison, Recker, Johnson, Gravenstein, Mor.

Statistical analysis: Berry, Goldfeld, McConeghy.

Obtained funding: Berry, McConeghy, Mitchell, Mor.

Administrative, technical, or material support: McConeghy, Gifford, Davidson, Han, Syme, Harrison, Recker, Johnson, Gravenstein, Mor.

Supervision: Gifford, Davidson, Harrison, Gravenstein, Mor.

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.

Funding/Support: This work was supported by a grant from the National Institute on Aging (U54AG063546).

Role of the Funder/Sponsor: The National Institute on Aging had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content and views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We would like to acknowledge the data analytic team at the American Healthcare Association center for Health Policy and Evaluation in LTC for providing data on facility and resident characteristics used in the randomization and analyses. They were not compensated for their work.

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