Nudge Communication for Flu Vaccination

(KP-VACCINATE Trial)

Not currently recruiting at 1 trial location

Overseen By Thida Tan, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Messaging opt-out, Unknown service area, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special messages focused on heart health can encourage more people to get their flu shot. The study will compare these heart-focused messages, known as Cardiovascular-Focused Nudge Communication, with regular reminders to identify which is more effective at increasing flu vaccination rates. Participants will receive either the new cardiovascular-focused messages or standard messages at different times during the flu season. Eligible individuals are Kaiser Permanente members who haven't yet received a flu shot this season and have access to the KP HealthConnect® Portal or email. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance public health strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this communication strategy is safe for improving vaccination uptake?

Research shows that simple reminders about the heart health benefits of flu shots effectively encourage vaccination. Studies have found that people receive these reminders well, and they help increase vaccination rates. Importantly, no evidence suggests these reminders have negative effects. They are messages designed to promote healthy behavior by highlighting how flu vaccines protect heart health, making them very safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to increasing flu vaccination rates using behavioral economics. The trial investigates cardiovascular-focused nudge communication, which is a fresh method compared to traditional reminders and educational campaigns. Unlike standard vaccination encouragement, which often relies on generic health messages, this approach tailors communication to highlight the cardiovascular benefits of getting vaccinated, potentially making it more relevant and motivating for certain individuals. By customizing messages to resonate with patients' health priorities, researchers hope to improve vaccination uptake and overall public health.

What evidence suggests that this trial's cardiovascular-focused nudge communication could be effective for increasing flu vaccination uptake?

Research has shown that messages focusing on heart health can effectively increase flu vaccination rates. In this trial, participants will receive different types of communication. Some will receive cardiovascular-focused nudge communication, which highlights how flu vaccines can benefit heart health, while others will receive usual care communication. Studies have found that heart-focused messages can increase vaccination rates by 11-14%. This method uses behavioral science to encourage vaccination by stressing the potential to prevent heart problems. Specifically, recipients of heart-focused messages were more likely to get their flu shots than those who received regular reminders. These findings suggest that emphasizing heart health benefits could be a promising way to boost flu vaccination rates. ^{2 6 7 8 9}

Who Is on the Research Team?

Ankeet Bhatt, MD

Principal Investigator

The Permanente Medical Group

Benjamin Galper, MD

Principal Investigator

Mid-Atlantic Permanente Medical Group

Are You a Good Fit for This Trial?

This trial is for members of Kaiser Permanente in Northern California and the Mid Atlantic States who are eligible to receive an influenza vaccine. The study aims to see if special communication focused on heart health can increase flu shot rates.

Inclusion Criteria

Active KPNC or KPMAS member

I have had health insurance with prescription coverage for at least 6 months before September 1, 2024.

I haven't received the flu vaccine for the 2024-2025 season.

Exclusion Criteria

I have received the flu vaccine.

I cannot or chose not to receive messages from my healthcare provider.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either CV-focused nudge communication or usual care communication at two different timepoints during the influenza season

8 months

2 communication touchpoints

Follow-up

Participants are monitored for safety and effectiveness after intervention, including all-cause hospitalization, emergency department visits, and major adverse cardiovascular events

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular-Focused Nudge Communication

Trial Overview The trial is testing whether a cardiovascular-focused 'nudge' communication can boost influenza vaccination uptake compared to usual care messages during the flu season.

How Is the Trial Designed?

Group I: Usual Care/CV Nudge Experimental Treatment 1 Intervention

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.

Group II: CV Nudge/Usual Care Experimental Treatment 1 Intervention

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.

Group III: CV Nudge/CV Nudge Experimental Treatment 1 Intervention

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.

Group IV: Usual Care/Usual Care Active Control 1 Intervention

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

Cardiovascular-Focused Nudge Communication is already approved in United States for the following indications:

Approved in United States as Cardiovascular-Focused Nudge Communication for:

• Improving influenza vaccination uptake among individuals with cardiovascular disease

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

A large-scale study involving 689,693 Walmart pharmacy patients found that text reminders increased flu vaccination rates by an average of 2.0 percentage points (6.8%) over three months.

The most effective reminder strategy was sending two texts three days apart, informing patients that a flu shot was 'waiting for you,' highlighting the importance of direct and repeated communication in encouraging vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 680,000-person megastudy of nudges to encourage vaccination in pharmacies. Milkman, KL., Gandhi, L., Patel, MS., et al.[2022]

In a 12-month study involving 182 adult patients with coronary disease, personalized behavioral nudges significantly increased statin adherence, with a proportion of days covered (PDC) of 0.742 in the nudge group compared to 0.639 in the control group (P = 0.042).

The nudge group also had a higher percentage of adherent subjects (66.3% with PDC ≥80%) compared to controls (50.5%, P = 0.036), indicating that AI-driven nudges can effectively enhance medication adherence without significant differences in serious health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. Horne, BD., Muhlestein, JB., Lappé, DL., et al.[2022]

In a study involving nearly 1 million Danish citizens aged 65 and older, those with cardiovascular disease (CVD) had a higher influenza vaccination rate (83.1%) compared to those without CVD (79.2%), indicating that CVD patients are more likely to get vaccinated.

Digital behavioral nudges, particularly letters highlighting cardiovascular benefits and reminder follow-ups, effectively increased vaccination rates for both CVD and non-CVD participants, suggesting that targeted communication can enhance vaccine uptake in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. Modin, D., Johansen, ND., Vaduganathan, M., et al.[2023]

In the NUDGE-FLU trial, 71.6% of patients with heart failure (HF) received the influenza vaccine, but only 44.6% of those under 65 were vaccinated, highlighting a significant gap in vaccination rates among younger HF patients.

The electronic nudging strategies used in the trial effectively increased vaccination rates without negatively impacting the use of guideline-directed medical therapy (GDMT), indicating that these nudges can be safely implemented in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nudges to increase influenza vaccination uptake among patients with heart failure: A pre-specified analysis of the NUDGE-FLU trial. Johansen, ND., Vaduganathan, M., Bhatt, AS., et al.[2023]

Nudges, which are small changes in the environment or information presentation, can significantly improve patient outcomes in healthcare by influencing behaviors.

To effectively implement nudges, it is crucial to systematically design them to fit clinical workflows, engage relevant stakeholders, and conduct rapid experimentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Nudges for Success in Health Care. Harrison, JD., Patel, MS.[2021]

A systematic review of 48 studies from high-income countries found that nudging interventions, such as reminders, framing information effectively, and using trusted messengers, can potentially increase vaccine confidence and uptake.

The most effective nudges included offering incentives and making information more salient, but the effectiveness varied by context, indicating a need for further research to adapt successful strategies across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging toward vaccination: a systematic review. Reñosa, MDC., Landicho, J., Wachinger, J., et al.[2021]

The NUDGE-FLU trial is a large-scale randomized implementation study involving 964,870 Danish citizens aged 65 and older, aimed at increasing influenza vaccination rates through digitally delivered behavioral nudges.

The trial will assess the effectiveness of these nudges by measuring vaccination uptake and timing, as well as exploring potential impacts on health outcomes like hospitalizations and mortality, providing valuable insights into improving vaccination strategies for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial. Johansen, ND., Vaduganathan, M., Bhatt, AS., et al.[2023]

Health-enhancing nudges, which aim to influence people's choices for better health, often fail because they do not consider the holistic understanding of individual health and can lead to negative emotional responses like resentment and anger.

These nudges can be detrimental to health as they assume people lack the ability to make their own choices, which can undermine their agency and lead to increased health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Health-enhancing Nudges Fail. Schramme, T.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870325001966

Electronically delivered, cardiovascular-focused ... First, this trial was specifically designed to evaluate the effectiveness and timing of a CV-focused nudge communication to promote influenza vaccination.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06571747

Study Details | NCT06571747 | Kaiser Permanente ... KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064270

Prespecified Analysis of the NUDGE-FLU Trial | Circulation Our results indicate that nudges focused on the cardiovascular benefits of influenza vaccines may be an effective strategy for inducing ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2824956

Electronic Nudges to Increase Influenza Vaccination in ... All 6 intervention strategies markedly increased influenza vaccination rates with absolute effect sizes ranging between 11-14 percentage points.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11581639/

Electronic Nudges to Increase Influenza Vaccination in ... Can electronically delivered letter-based nudges informed by behavioral science increase influenza vaccination uptake among young and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40884406/

Cardiovascular-Focused Messaging to Improve Influenza ... Cardiovascular-Focused Messaging to Improve Influenza Vaccination Rates.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064270?doi=10.1161/CIRCULATIONAHA.123.064270

Effect of Electronic Nudges on Influenza Vaccination Rate ... Our results indicate that nudges focused on the cardiovascular benefits of influenza vaccines may be an effective strategy for inducing behavioral change ...

8. withpower.com withpower.com/trial/phase-social-behavior-8-2024-0a3b4?condition=influenza&hasNoPlacebo=false&overallStatus=Recruiting

Nudge Communication for Flu Vaccination In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and ...

9. jmir.org jmir.org/2022/10/e38710/

Influence of Digital Intervention Messaging on Influenza ... Electronic nudges increase influenza vaccination utilization after myocardial infarction: the nationwide NUDGE-FLU implementation trial.