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Behavioral Intervention

CV Nudge/Usual Care for Social Behavior (KP-VACCINATE Trial)

N/A
Waitlist Available
Led By Ankeet Bhatt, MD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age ≥18 years
2. Active KPNC or KPMAS member
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights

Summary

In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular (CV) events and mortality in select populations. However, the potential population-level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed. KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season.

Who is the study for?
This trial is for members of Kaiser Permanente in Northern California and the Mid Atlantic States who are eligible to receive an influenza vaccine. The study aims to see if special communication focused on heart health can increase flu shot rates.
What is being tested?
The trial is testing whether a cardiovascular-focused 'nudge' communication can boost influenza vaccination uptake compared to usual care messages during the flu season.
What are the potential side effects?
Since this trial involves communication strategies rather than medical treatments, there are no direct side effects from interventions like you would expect with drugs or surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with documented influenza vaccine receipt
Secondary study objectives
Time to influenza vaccine receipt

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care/CV NudgeExperimental Treatment1 Intervention
Intervention arms will test the effects of a cardiovascular-focused nudge communication developed using behavioral economic principles. This arm will receive the usual care communication at first timepoint and then cardiovascular-focused nudge communication at the second timepoint during the influenza season.
Group II: CV Nudge/Usual CareExperimental Treatment1 Intervention
Intervention arms will test the effects of a cardiovascular-focused nudge communication developed using behavioral economic principles. This arm will receive the cardiovascular-focused nudge communication at first timepoint and then usual care communication at the second timepoint during the influenza season.
Group III: CV Nudge/CV NudgeExperimental Treatment1 Intervention
Intervention arms will test the effects of a cardiovascular-focused nudge communication developed using behavioral economic principles. This arm will receive the cardiovascular-focused nudge communication at 2 different timepoints during the influenza season.
Group IV: Usual Care/Usual CareActive Control1 Intervention
The usual care arm will receive standard-of-care communication encouraging vaccination at both timepoints during the influenza season.

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
543 Previous Clinical Trials
23,907,130 Total Patients Enrolled
Ankeet Bhatt, MDPrincipal InvestigatorThe Permanente Medical Group
Natalia Berry, MDPrincipal InvestigatorMid-Atlantic Permanente Medical Group
~2500000 spots leftby Aug 2025
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