Staff Engagement Strategy for COVID-19 Vaccination

(ENSPIRE Trial)

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

988 Participants Needed

Trial Summary

What is the purpose of this trial?

The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia. Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.

Will I have to stop taking my current medications?

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

Is the COVID-19 vaccine safe for humans?

Research shows that COVID-19 vaccines are generally safe for humans, with most side effects being mild to moderate and not affecting daily activities. Serious adverse events are rare, and ongoing monitoring ensures vaccine safety. ^{1 2 3 4 5}

How does the treatment 'Full Intervention' differ from other COVID-19 vaccination strategies for staff?

The 'Full Intervention' treatment is unique because it focuses on engaging staff through strategies like education, incentives, and communication to overcome vaccine hesitancy, rather than just relying on mandates or traditional vaccination campaigns. This approach aims to build confidence and acceptance of COVID-19 vaccines among staff by addressing specific concerns and barriers. ^{6 7 8 9 10}

Research Team

Clarissa Hsu, PhD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I am 17 years old or younger.

Does not work at an enrolled long-term care facility

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccine safety in Australia during the COVID-19 pandemic: Lessons learned on the frontline. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Consumer reporting of adverse events following immunization (AEFI): identifying predictors of reporting an AEFI. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Strategies to Increase Willingness to Receive a COVID-19 Vaccine among Nursing Home Staff. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

COVID-19 vaccine hesitancy in care home staff: A survey of Liverpool care homes. [2023]

8. England pubmed.ncbi.nlm.nih.gov

COVID-19 vaccine uptake among healthcare workers: an achievable quality improvement target. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Strategies associated with COVID-19 vaccine coverage among nursing home staff. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccination Among Skilled Nursing Facility Staff: Challenges and Strategies Identified by Administrators. [2023]