Improving COVID-19 Vaccine Uptake in Nursing Homes
IMPACT-C: Improving Vaccine Uptake in Skilled Nursing Facilities
3 other identifiers
interventional
23,768
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2020
CompletedFirst Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2021
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
September 1, 2021
3 months
January 27, 2021
July 22, 2021
September 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Residents Who Received SARS-CoV-2 Vaccine
A binary measure (Yes or No) indicating whether a long stay nursing home resident received any dose of a SARS-CoV-2 vaccine, identified by the electronic medical records (EMR) within the study period.
15 weeks
Secondary Outcomes (1)
Number of Staff Who Received SARS-CoV-2 Vaccine
15 weeks
Study Arms (2)
Usual care
NO INTERVENTIONFacilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
High touch
EXPERIMENTALFacilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- National Institute on Aging (NIA)collaborator
- Hebrew SeniorLifecollaborator
- Insight Therapeutics, LLCcollaborator
- New York Universitycollaborator
Study Sites (4)
Mission Health
Tampa, Florida, 33629, United States
Nexion Health
Sykesville, Maryland, 21784, United States
Vetter Senior Living
Elkhorn, Nebraska, 68022, United States
Genesis HealthCare
Kennett Square, Pennsylvania, 19348, United States
Related Publications (1)
Berry SD, Goldfeld KS, McConeghy K, Gifford D, Davidson HE, Han L, Syme M, Gandhi A, Mitchell SL, Harrison J, Recker A, Johnson KS, Gravenstein S, Mor V. Evaluating the Findings of the IMPACT-C Randomized Clinical Trial to Improve COVID-19 Vaccine Coverage in Skilled Nursing Facilities. JAMA Intern Med. 2022 Mar 1;182(3):324-331. doi: 10.1001/jamainternmed.2021.8067.
PMID: 35099523DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarah Berry, MD
- Organization
- Hebrew SeniorLife
Study Officials
- STUDY DIRECTOR
Sarah D Berry, MD, MPH
Hebrew SeniorLife
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 1, 2021
Study Start
December 21, 2020
Primary Completion
March 31, 2021
Study Completion
April 16, 2021
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The IPD and supporting documentation will be available through the CDCC within 6 months of the completion of the trial.
- Access Criteria
- Staff and patient data will be aggregated at the level of the facility. This data will be shared with the RADx-UP CDCC, who plans to make a central database that will ultimately be publicly available.
Data will be aggregated at the level of the facility. We will provide aggregated data to the RADx-UP Coordination and Data Collection Center (CDCC); however, given the nature of this data it will not be identifiable or linkable. The CDCC will facilitate cross-site pooling of data, whenever possible, and create a publicly available dataset with this information.