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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular-Focused Nudge Communication | Behavioral | Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to influenza vaccine receipt | Time from randomization to influenza vaccine receipt. | up to 8 months |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ankeet Bhatt, MD | The Permanente Medical Group | Principal Investigator |
| Benjamin Galper, MD | Mid-Atlantic Permanente Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Pleasanton | California | 94588 | United States | ||
| Kaiser Permanente Mid Atlantic States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40884406 | Derived | 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. | |
| 40541687 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007251 | Influenza, Human |
| D012919 | Social Behavior |
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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 |
| Bethesda |
| Maryland |
| 20852 |
| United States |
| 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. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |