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

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-Sørensen, T; Claggett, BL; Johansen, ND; Jones, A; Ku, IA; Solomon, SD; Vaduganathan, M; Galper, BZ; Lee, KL; Berry, NC; KP-VACCINATE Investigators

doi:10.1016/j.ahj.2025.06.007

Cardio-oncology & other

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 JPublished 18 Jun 2025Randomised controlled trial

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Authors' conclusion

KP-VACCINATE is one of the largest clinical trials conduted to date, enrolling more than 3.6 million adults, and uniquely embedded in a integrated healthcare delivery system.

Study context

Population: Unvaccinated adults aged >18 years reachable by health system secure messaging or email, Kaiser Permanente Northern California (KPNC) and KPMAS, 2024–2025 influenza seasonrandomized
Participants: 3,668,428 adults

Comparison: Cardiovascular (CV)-focused communication vs usual care communication
Primary endpoint: Receipt of influenza vaccination
Follow-up: On or before January 1, 2025

Methodological detailsrationale, design and baseline characteristics, multicentre, megatrial, 1:1:1:1 randomisation, 4 arms, 6 coprimary comparisons, 3,234,745 randomized at KPNC, 433,683 at KPMAS, Secondary outcome: time to vaccination; exploratory: MACE, all-cause death, implementation outcomes

Rationale, design and baseline characteristics
Multicentre
Megatrial
1:1:1:1 randomisation
4 arms
6 coprimary comparisons
3,234,745 randomized at KPNC, 433,683 at KPMAS
Secondary outcome: time to vaccination; exploratory: MACE, all-cause death, implementation outcomes

Primary result

As reported in the abstract

Baseline characteristics of randomised participants

Age, mean (SD): 48.3 (18.2) years
Female: 1,939,380 (52.9%)
Black: 10.5%
Asian and Native Hawaiian/Pacific Islander: 791,658 (21.6%)
Hispanic ethnicity: 774,790 (21.1%)
Vaccination rate in prior 2023-2024 influenza season: 38.8%

Reference

Authors: Bhatt AS, Go AS, Parikh RV, Ballance Z, Tan TC, Marafino BJ, et al.
All 23 authors
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-Sørensen T, Claggett BL, Johansen ND, Jones A, Ku IA, Solomon SD, Vaduganathan M, Galper BZ, Lee KL, Berry NC, KP-VACCINATE Investigators
Journal: American Heart Journal
Published: 18 Jun 2025
DOI: 10.1016/j.ahj.2025.06.007
PubMed: 40541687
Registration: NCT06571747

Country: United States
Topic: Cardio-oncology & other

Intervention details

Arm 1: two rounds of CV nudging (initial and reminder letter)
Arm 2: one round of CV nudging, early
Arm 3: CV nudging, late

Key notes

Cardiometabolic comorbidities (HF, diabetes, hypertension) approximated US adult population
Design and baseline report; primary outcome results not yet reported

Original publication

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. Published 18 June 2025. doi:10.1016/j.ahj.2025.06.007

Read the original article ↗

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