Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3668428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular 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.

The study will evaluate an operational directive at KPNC and KPMAS. Eligible participants will be randomized into 4 study arms, corresponding to the messaging received at two different vaccine communication touchpoints (Touchpoint 1/Touchpoint 2) during the 2024-2025 influenza season:

1. CV-focused nudge communication/CV-focused nudge communication
2. CV-focused nudge communication/Usual care communication
3. Usual care communication/CV-focused nudge communication
4. Usual care communication/Usual care communication

Conditions

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Cardiovascular Diseases Influenza Behavior, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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CV Nudge/CV Nudge

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 Type EXPERIMENTAL

Cardiovascular-Focused Nudge Communication

Intervention Type BEHAVIORAL

Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.

CV Nudge/Usual Care

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 Type EXPERIMENTAL

Cardiovascular-Focused Nudge Communication

Intervention Type BEHAVIORAL

Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.

Usual Care/CV Nudge

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 Type EXPERIMENTAL

Cardiovascular-Focused Nudge Communication

Intervention Type BEHAVIORAL

Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.

Usual Care/Usual Care

The usual care arm will receive standard-of-care communication encouraging vaccination at both timepoints during the influenza season.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiovascular-Focused Nudge Communication

Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Active KPNC or KPMAS member
3. ≥6 months of continuous health plan coverage and prescription drug benefit before September 1, 2024
4. Evidence of member access to the KP HealthConnect® Portal and/or a listed registered email address
5. No documented influenza vaccination during the 2024-2025 influenza season prior to randomization

Exclusion Criteria

1. Unable to receive or opted out of receiving health system messaging
2. Other exclusion that prevents messaging outreach.
3. Unknown service area or medical center affiliation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes