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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
No Placebo-Only Group
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.
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.
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 belowSelect...
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 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Secondary Immunization
Change in likelihood of recommending COVID-19 vaccination
Secondary study objectives
Change in COVID-19 vaccine confidence
Change in vaccine hesitancy
Other study objectives
Change in COVID-19 vaccine attitudes
Change in COVID-19 vaccine knowledge
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,730,634 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,144 Total Patients Enrolled
Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility 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.I am 17 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: Full Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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