Cardiovascular DiseasesKP-VACCINATENCT06571747
Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement
A study testing Cardiovascular-Focused Nudge Communication in people with Cardiovascular Diseases and Influenza, run by Kaiser Permanente at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Influenza, Behavior, Social
- What is being tested?
- Cardiovascular-Focused Nudge Communication
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,668,428 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to receive or opted out of receiving health system messaging
- Other exclusion that prevents messaging outreach.
- Unknown service area or medical center affiliation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Mid Atlantic States
Bethesda, Maryland, 20852
Kaiser Permanente Northern California
Pleasanton, California, 94588
About this study
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.
Read the 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:
- 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
- Conditions
- Cardiovascular Diseases, Influenza, Behavior, Social
- Being tested
- Cardiovascular-Focused Nudge Communication
- Keywords
- Vaccination, Nudges, Behavioral Science, Cardiovascular Disease, Myocardial Infarction, Heart Failure, Implementation Science
- Medical subject headings
- Cardiovascular Diseases, Influenza, Human, Social Behavior, Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular-Focused Nudge CommunicationBehavioural
Intervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with documented influenza vaccine receipt
Proportion of participants with documented influenza vaccine receipt after randomization.
Measured: up to 8 months
Secondary outcomes (1)
Time to influenza vaccine receipt
Time from randomization to influenza vaccine receipt.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start5 Sep 2024
- Primary completion1 May 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,668,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ankeet Bhatt, MD, Principal investigator, The Permanente Medical GroupBenjamin Galper, MD, Principal investigator, Mid-Atlantic Permanente Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571747
- Sponsor's protocol ID
- KP-VACCINATE
- Acronym
- KP-VACCINATE
- Status last verified
- May 2025
- First submitted
- 22 Aug 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40884406Bhatt 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.
PubMed 40541687
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaiser Permanente VACCination Improvement With Nudge-based CardiovAscular Targeted Engagement
- ClinicalTrials.gov ID
- NCT06571747
- Acronym / sponsor ID
- KP-VACCINATE / KP-VACCINATE
- Conditions
- Cardiovascular Diseases, Influenza, Behavior, Social
- Keywords
- Vaccination, Nudges, Behavioral Science, Cardiovascular Disease, Myocardial Infarction, Heart Failure, Implementation Science
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,668,428 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CV Nudge/CV Nudge | Experimental | Behavioral: Cardiovascular-Focused Nudge CommunicationIntervention 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 | Behavioral: Cardiovascular-Focused Nudge CommunicationIntervention 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 | Behavioral: Cardiovascular-Focused Nudge CommunicationIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to receive or opted out of receiving health system messaging
- Other exclusion that prevents messaging outreach.
- Unknown service area or medical center affiliation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular-Focused Nudge CommunicationIntervention arms will receive a behavioral economic rooted nudge communication highlighting the potential cardiovascular benefits of vaccination. | Behavioural | CV Nudge/CV Nudge, CV Nudge/Usual Care, Usual Care/CV Nudge |
Primary outcome
Proportion of participants with documented influenza vaccine receipt
Time frame: up to 8 months
Proportion of participants with documented influenza vaccine receipt after randomization.
1 secondary outcome
Time to influenza vaccine receipt
Time frame: up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 40884406Bhatt 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.
- Derived from this study: PubMed 40541687Bhatt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankeet Bhatt, MD principal investigator
The Permanente Medical Group
Benjamin Galper, MD principal investigator
Mid-Atlantic Permanente Medical Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular-Focused Nudge Communication in people with Cardiovascular Diseases and Influenza, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with documented influenza vaccine receipt (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06571747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.