Nudge Communication for Flu Vaccination

(KP-VACCINATE Trial)

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

3750000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Cardiovascular-Focused Nudge Communication for flu vaccination?

Research from the NUDGE-FLU trial shows that electronic nudges, such as letters highlighting cardiovascular benefits of flu vaccination, effectively increased vaccination rates among patients with heart conditions in Denmark. ^{1 2 3 4 5}

Is nudge communication for flu vaccination safe for humans?

The research on nudge communication for flu vaccination, such as the NUDGE-FLU trial, does not report any safety concerns for humans. These studies focus on increasing vaccination rates through digital reminders and do not involve any direct medical interventions. ^{1 2 5 6 7}

How is Cardiovascular-Focused Nudge Communication different from other treatments for flu vaccination?

Cardiovascular-Focused Nudge Communication is unique because it uses digital behavioral nudges, specifically electronic letters, to increase flu vaccination rates by highlighting the cardiovascular benefits of vaccination, which is particularly targeted at patients with cardiovascular disease. This approach differs from traditional methods by focusing on personalized communication to encourage vaccination uptake. ^{1 2 5 7 8}

Research Team

Ankeet Bhatt, MD

Principal Investigator

The Permanente Medical Group

Natalia Berry, MD

Principal Investigator

Mid-Atlantic Permanente Medical Group

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Designing Nudges for Success in Health Care. [2021]

5. United States 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Why Health-enhancing Nudges Fail. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A 680,000-person megastudy of nudges to encourage vaccination in pharmacies. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Nudging toward vaccination: a systematic review. [2021]