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Active, Not Recruiting

NCT Number: NCT06571747

Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Behavior Behavior, Social Heart Diseases Heart Failure Infarction Infections Influenza Influenza, Human Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Social Behavior Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California, Pleasanton, California, United States

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About this study

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:

  • CV-focused nudge communication/CV-focused nudge communication
  • CV-focused nudge communication/Usual care communication
  • Usual care communication/CV-focused nudge communication
  • Usual care communication/Usual care communication

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cardiovascular-Focused Nudge Communication

Behavioral

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

Primary outcomes

  1. Proportion of participants with documented influenza vaccine receipt

    Time frame: up to 8 months

    Proportion of participants with documented influenza vaccine receipt after randomization.

Secondary outcomes

  1. Time to influenza vaccine receipt

    Time frame: up to 8 months

    Time from randomization to influenza vaccine receipt.

Other outcomes

  1. Laboratory-confirmed influenza infection

    Time frame: Up to 12 months

    Incidence of laboratory-confirmed influenza infection.

  2. Hospitalization for influenza or pneumonia.

    Time frame: Up to 12 months

    Hospitalization for influenza or pneumonia.

  3. All Cause Resource Utilization

    Time frame: Up to 12 months

    Composite and individual components of: All-cause hospitalization, emergency department (ED) visits, and observation stays

  4. Total inpatient days

    Time frame: Up to 12 months

    Total inpatient days

  5. All-cause intensive care unit (ICU) days

    Time frame: Up to 12 months

    All-cause intensive care unit (ICU) days

  6. Major Adverse Cardiovascular Events

    Time frame: Up to 12 months

    Composite and individual components of major adverse CV events: incident or worsening heart failure events, hospitalization for acute myocardial infarction, atrial fibrillation, venous thromboembolism and hospitalization for acute stroke

  7. All-cause death

    Time frame: Up to 12 months

    All-cause death, ascertained through a combination of Social Security Administration files, state death certificate files, electronic health records, and member proxy reporting.

  8. Composite of major adverse CV events and all cause death

    Time frame: Up to 12 months

    Composite of major adverse CV events (incident or worsening heart failure events, hospitalization for acute myocardial infarction, atrial fibrillation, venous thromboembolism and hospitalization or acute stroke) and all-cause death.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Acronym: KP-VACCINATE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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