Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement (KP-VACCINATE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Influenza; Behavior, Social
• Intervention / Treatment: Behavioral: Cardiovascular-Focused Nudge Communication

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 Type: Interventional
• Enrollment (Actual): 3668428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Kaiser Permanente Northern California
  • Maryland
    • Bethesda, Maryland, United States, 20852
      • Kaiser Permanente Mid Atlantic States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care/Usual Care; The usual care arm will receive standard-of-care communication encouraging vaccination at both timepoints during the influenza season.
Experimental: 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.	Behavioral: Cardiovascular-Focused Nudge Communication; Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.
Experimental: 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.	Behavioral: Cardiovascular-Focused Nudge Communication; Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.
Experimental: 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.	Behavioral: Cardiovascular-Focused Nudge Communication; Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with documented influenza vaccine receipt	Proportion of participants with documented influenza vaccine receipt after randomization.	up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to influenza vaccine receipt	Time from randomization to influenza vaccine receipt.	up to 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory-confirmed influenza infection	Incidence of laboratory-confirmed influenza infection.	Up to 12 months
Hospitalization for influenza or pneumonia.	Hospitalization for influenza or pneumonia.	Up to 12 months
All Cause Resource Utilization	Composite and individual components of: All-cause hospitalization, emergency department (ED) visits, and observation stays	Up to 12 months
Total inpatient days	Total inpatient days	Up to 12 months
All-cause intensive care unit (ICU) days	All-cause intensive care unit (ICU) days	Up to 12 months
Major Adverse Cardiovascular Events	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	Up to 12 months
All-cause death	All-cause death, ascertained through a combination of Social Security Administration files, state death certificate files, electronic health records, and member proxy reporting.	Up to 12 months
Composite of major adverse CV events and all cause death	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Ankeet Bhatt, MD, The Permanente Medical Group; Principal Investigator: Benjamin Galper, MD, Mid-Atlantic Permanente Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Disease; Vaccination; Myocardial Infarction; Implementation Science; Behavioral Science; Nudges
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: KP-VACCINATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes