Staff Engagement Strategy for COVID-19 Vaccination

(ENSPIRE Trial)

Not currently recruiting at 1 trial location

Overseen By James Fraser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to boost COVID-19 booster vaccination rates among staff at long-term care facilities. It compares a new strategy, the "Full Intervention," which involves creating and sharing custom materials with staff from various cultural and language backgrounds, against standard vaccine education materials from organizations like the CDC. The trial takes place in Washington state and Georgia, focusing on facilities with lower booster rates. Eligible participants are staff members at these facilities with a booster rate of 60% or less as of December 2021. As an unphased trial, this study allows participants to contribute to innovative strategies that could improve public health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this communication and engagement strategy is safe for increasing COVID-19 booster vaccination rates among facility staff?

Research shows that COVID-19 vaccines, included in this trial, are generally safe. Studies have found that while side effects can occur, serious health issues are rare. For instance, research on booster shots found no significant increase in serious health risks.

The CDC and FDA maintain systems to monitor vaccine safety and detect any unusual patterns or side effects. These systems help ensure vaccines remain safe for everyone. Overall, evidence suggests that COVID-19 vaccines are well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Staff Engagement Strategy for COVID-19 Vaccination trial because it explores a novel approach to boosting vaccination rates through community-driven engagement. Unlike standard methods that rely heavily on generic promotional materials, this trial emphasizes the development of culturally and linguistically tailored materials, co-designed with specific community groups. This peer advocacy model leverages the influence of community members themselves, aiming to increase trust and acceptance of the vaccine. By involving participants in the creation and distribution process, the trial hopes to overcome barriers like language and cultural differences, potentially leading to higher vaccination rates in diverse communities.

What evidence suggests that this trial's strategies could be effective for increasing COVID-19 booster vaccination rates?

Research has shown that personalized communication can increase COVID-19 vaccination rates. In this trial, participants in the "Full Intervention" arm will receive materials co-designed with input from specific cultural or language groups, distributed with help from peer advocates. Studies have found that materials created with such input lead to greater engagement and trust. For example, when individuals from these groups explain vaccine benefits, understanding and acceptance improve. This method addresses the specific concerns and needs of different staff members. Early results indicate that these personalized strategies outperform the "Enhanced Usual Care" arm, which uses standard information from national organizations. In summary, relatable and respectful communication appears to boost vaccination rates. ^{6 7 8 9 10}

Who Is on the Research Team?

Clarissa Hsu, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for staff at long-term care facilities in Washington state or Georgia, with more than 50 employees and a COVID-19 booster vaccination rate of ≤60% as of December 1, 2021. Participants must be adults (18+). Staff from non-enrolled facilities or those under 18 are excluded.

Inclusion Criteria

You work at a long-term care facility in Washington state or Georgia with over 50 staff members and where less than 60% of the staff have received a COVID-19 booster vaccination by December 1, 2021.

Exclusion Criteria

I am 17 years old or younger.

Does not work at an enrolled long-term care facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Collection of baseline data and randomization of facilities to trial arms

1 month

1 visit (virtual)

Intervention

Implementation of communication and engagement strategy to increase COVID-19 booster vaccination rates

6 months

Ongoing engagement activities

Follow-up

Monitoring of vaccination rates and survey completion at multiple timepoints post-intervention

7 months

3 surveys (online)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Full Intervention

Trial Overview The ENSPIRE study compares a tailored communication strategy to increase COVID-19 booster rates against enhanced usual care using CDC materials. The full intervention includes custom materials and peer advocacy for diverse cultural/language groups.

How Is the Trial Designed?

Group I: Full Intervention Experimental Treatment 1 Intervention

Development of materials co-designed with and tailored to language/cultural affinity groups and distributed with assistance from co-design participants who will serve as peer advocates.

Group II: Enhanced Usual Care Active Control 1 Intervention

Distribution of COVID-19 vaccine promotion materials from the Centers for Disease Control and Prevention \[CDC\] or other national organization with limited distribution support at long-term care centers.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)

Collaborator

Trials

1

Recruited

990+

Published Research Related to This Trial

A scoping review of 11 studies found that adverse events related to COVID-19 vaccinations are generally mild to moderate, with no significant impact on daily activities and no unique patterns in vaccine-related deaths, indicating a strong safety profile for the vaccines.

The review highlights the importance of accurate public communication regarding vaccine side effects and emphasizes the need for strategies to address vaccine hesitancy, suggesting that future research should focus on diverse populations and medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. Dhamanti, I., Suwantika, AA., Adlia, A., et al.[2023]

Healthcare professionals are ethically and legally required to report any suspected adverse events from vaccinations to national agencies like the Vaccine Adverse Event Reporting System (VAERS), which helps monitor vaccine safety.

Data from VAERS and other reporting systems indicate that the rates of adverse events from approved SARS-CoV-2 vaccines are very low, supporting the safety of these vaccines and suggesting that this monitoring approach could be useful for future vaccines against other zoonotic infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: What Can be Learned from National and International Vaccine Adverse Event Reporting Systems During the COVID-19 Pandemic? Parums, DV.[2022]

A narrative literature review was conducted to summarize adverse events following immunization (AEFI) with COVID-19 vaccines, highlighting the growing body of knowledge on their safety and efficacy.

The review emphasizes the importance of understanding probable AEFI to enhance public awareness and confidence in COVID-19 vaccination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. Bhandari, B., Rayamajhi, G., Lamichhane, P., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423003269

Engaging staff to improve COVID-19 vaccination response ... Our cluster-randomized trial tests an innovative method for tailoring COVID-19 vaccine promotion materials and analyzes the effects of tailored materials.

2. withpower.com withpower.com/trial/phase-covid-19-7-2021-1c9b4

Staff Engagement Strategy for COVID-19 Vaccination · Info ... The 'Full Intervention' treatment is unique because it focuses on engaging staff through strategies like education, incentives, and communication to overcome ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9347311/

Interventions to increase COVID‐19 vaccine uptake This scoping review maps interventions aimed at increasing COVID‐19 vaccine uptake and decreasing COVID‐19 vaccine hesitancy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05449418

NCT05449418 | Engaging Staff to Improve COVID-19 ... The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities

5. ctv.veeva.com ctv.veeva.com/study/engaging-staff-to-improve-covid-19-vaccination-response-at-long-term-care-facilities

Engaging Staff to Improve COVID-19 Vaccination Response at ... The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/covid-19.html

Coronavirus Disease 2019 (COVID-19) Vaccine Safety Several factors explain reports of death after COVID-19 vaccination. · Data shows that people who receive COVID-19 vaccines are less likely to die from COVID-19 ...

7. cdc.gov cdc.gov/acip/downloads/slides-2025-06-25-26/04-Meyer-COVID-508.pdf

Update on CDC's COVID-19 Vaccine Safety Monitoring Co-managed by CDC and FDA. • Nationwide spontaneous reporting system that can rapidly detect safety signals, including rare events.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836889

Safety of JN.1-Updated mRNA COVID-19 Vaccines This cohort study investigates the association between booster vaccinations containing the JN.1 lineage and 29 serious adverse events in ...

9. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance

COVID-19 Vaccine Safety Surveillance This page describes the monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8315897/

Evaluation of the safety profile of COVID-19 vaccines For the safety profile of COVID-19 vaccines in clinical trials, the primary outcomes were the proportion of vaccine recipients experiencing at least one AEFI ...