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Staff Engagement Strategy for COVID-19 Vaccination (ENSPIRE Trial)

N/A
Waitlist Available
Led By Clarissa Hsu, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Be older than 18 years old
Must not have
17 years or younger
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (time 0); 7 months post-randomization (time 1); 10 months post-randomization (time 2); 13 months post-randomization (time 3)
Awards & highlights

Summary

This trial is testing a communication and engagement strategy to see if it increases COVID-19 booster vaccination rates among facility staff. The strategy being tested includes developing materials tailored to staff whose primary language is not English or who are from certain cultural affinity groups, and distributing these materials by members of the same language/cultural affinity groups. The trial is being conducted in Washington state and Georgia.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on engagement strategies rather than medical interventions, there are no direct side effects from drugs or treatments being tested. However, participants may experience indirect effects related to the implementation of these strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am 17 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (time 0); 7 months post-randomization (time 1); 10 months post-randomization (time 2); 13 months post-randomization (time 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 0); 7 months post-randomization (time 1); 10 months post-randomization (time 2); 13 months post-randomization (time 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary Immunization
Change in likelihood of recommending COVID-19 vaccination
Secondary outcome measures
Change in COVID-19 vaccine confidence
Change in vaccine hesitancy
Other outcome measures
Change in COVID-19 vaccine attitudes
Change in COVID-19 vaccine knowledge

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Full InterventionExperimental Treatment1 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 CareActive Control1 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.

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
542 Previous Clinical Trials
23,906,142 Total Patients Enrolled
7 Trials studying COVID-19
407,226 Patients Enrolled for COVID-19
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,991,162 Total Patients Enrolled
10 Trials studying COVID-19
463,226 Patients Enrolled for COVID-19
Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)UNKNOWN

Media Library

Full Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05449418 — N/A
COVID-19 Research Study Groups: Enhanced Usual Care, Full Intervention
COVID-19 Clinical Trial 2023: Full Intervention Highlights & Side Effects. Trial Name: NCT05449418 — N/A
Full Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05449418 — N/A
~252 spots leftby Jul 2025
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