Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement

Not Applicable

Recruiting

• Conditions: Behavior, Social; Cardiovascular Diseases; Influenza
• Interventions: Behavioral: Cardiovascular-Focused Nudge Communication

• Registration Number: NCT06571747
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-26
• Status Verified: 2024-09
• Study Start: 2024-09-05
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-08-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3750000

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CV Nudge/CV Nudge	Cardiovascular-Focused Nudge Communication	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.
Usual Care/CV Nudge	Cardiovascular-Focused Nudge Communication	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.
CV Nudge/Usual Care	Cardiovascular-Focused Nudge Communication	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with documented influenza vaccine receipt	up to 8 months	Proportion of participants with documented influenza vaccine receipt after randomization.

Secondary Outcome Measures

Name	Time	Method
Time to influenza vaccine receipt	up to 8 months	Time from randomization to influenza vaccine receipt.

Trial Locations

Locations (2)

Kaiser Permanente Northern California; 🇺🇸 Pleasanton, California, United States

Kaiser Permanente Mid Atlantic States; 🇺🇸 Bethesda, Maryland, United States