Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement

NCT06571747 | Active Not Recruiting

• 1 other identifier: KP-VACCINATE
• Study Type: interventional
• Target: 3,668,428
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Influenza; Behavior, Social

Keywords

Vaccination; Nudges; Behavioral Science; Cardiovascular Disease; Myocardial Infarction; Heart Failure; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with documented influenza vaccine receipt

  Proportion of participants with documented influenza vaccine receipt after randomization.

  up to 8 months

Secondary Outcomes (1)

• Time to influenza vaccine receipt

  up to 8 months

Other Outcomes (8)

• Laboratory-confirmed influenza infection

  Up to 12 months

• Hospitalization for influenza or pneumonia.

  Up to 12 months

• All Cause Resource Utilization

  Up to 12 months

Study Arms (4)

CV Nudge/CV Nudge

EXPERIMENTAL

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

CV Nudge/Usual Care

EXPERIMENTAL

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

Usual Care/CV Nudge

EXPERIMENTAL

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

Usual Care/Usual Care

NO INTERVENTION

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

Interventions

Cardiovascular-Focused Nudge Communication BEHAVIORAL

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

CV Nudge/CV Nudge; CV Nudge/Usual Care; Usual Care/CV Nudge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to receive or opted out of receiving health system messaging
• Unknown service area or medical center affiliation.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (2)

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location

Kaiser Permanente Mid Atlantic States

Bethesda, Maryland, 20852, United States

Location

Related Publications (2)

• Bhatt AS, Berry NC, Parikh RV, Ballance Z, Tan TC, Marafino BJ, Hu H, Mummert M, Ambrosy AP, Hernandez-Diaz G, Fitch R, Patel S, Biering-Sorensen T, Claggett BL, Johansen ND, Jones A, Ku IA, Solomon SD, Vaduganathan M, Galper BZ, Lee KL, Go AS. Cardiovascular-Focused Messaging to Improve Influenza Vaccination Rates. NEJM Evid. 2025 Oct;4(10):EVIDoa2500208. doi: 10.1056/EVIDoa2500208. Epub 2025 Aug 30.

  PMID: 40884406 DERIVED

• Bhatt AS, Go AS, Parikh RV, Ballance Z, Tan TC, Marafino BJ, Hu H, Mummert M, Ambrosy AP, Hernandez-Diaz G, Fitch R, Patel S, Biering-Sorensen T, Claggett BL, Johansen ND, Jones A, Ku IA, Solomon SD, Vaduganathan M, Galper BZ, Lee KL, Berry NC; KP-VACCINATE Investigators. Electronically delivered, cardiovascular-focused messaging to improve influenza vaccination: Rationale, design, and baseline characteristics of the Kaiser Permanente VACCination Improvement with Nudge-based CardiovAscular Targeted Engagement (KP-VACCINATE) Megatrial. Am Heart J. 2025 Dec;290:129-139. doi: 10.1016/j.ahj.2025.06.007. Epub 2025 Jun 18.

  PMID: 40541687 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Influenza, Human; Social Behavior; Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Behavior; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ankeet Bhatt, MD

  The Permanente Medical Group

  PRINCIPAL INVESTIGATOR

• Benjamin Galper, MD

  Mid-Atlantic Permanente Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 5, 2024
• Primary Completion: May 1, 2025
• Study Completion: March 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)