Nudge Communication for Flu Vaccination (KP-VACCINATE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kaiser Permanente
No Placebo Group
Approved in 1 jurisdiction
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.
12345Is 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.
12567How 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.
12578Eligibility 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
I am 18 years old or older.
Exclusion Criteria
I cannot or chose not to receive messages from my healthcare provider.
Participant Groups
The trial is testing whether a cardiovascular-focused 'nudge' communication can boost influenza vaccination uptake compared to usual care messages during the flu season.
4Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care/CV NudgeExperimental Treatment1 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 CareExperimental Treatment1 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 NudgeExperimental Treatment1 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 CareActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Kaiser Permanente Northern CaliforniaPleasanton, CA
Kaiser Permanente Mid Atlantic StatesBethesda, MD
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Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
References
Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. [2023]Influenza vaccines have been demonstrated to effectively reduce the incidence of influenza infection and potentially associated risks of cardiovascular events in patients with cardiovascular disease (CVD). Despite strong guideline and public health endorsements, global influenza vaccination rates in patients with CVD are highly variable. This prespecified analysis of NUDGE-FLU (Nationwide Utilization of Danish Government Electronic Letter System for Increasing Influenza Vaccine Uptake) examined the effect of digital behavioral nudges on influenza vaccine uptake based on the presence of CVD.
Electronic nudges to increase influenza vaccination uptake among patients with heart failure: A pre-specified analysis of the NUDGE-FLU trial. [2023]Seasonal influenza vaccination is strongly recommended in patients with heart failure (HF). The NUDGE-FLU trial recently found two electronic behavioural nudging letter strategies - a letter highlighting potential cardiovascular benefits of vaccination and a repeated letter at day 14 -effective in increasing influenza vaccination in Denmark. The aims of this pre-specified analysis was to further examine vaccination patterns and effects of these behavioural nudges in patients with HF including potential off-target effects on guideline-directed medical therapy (GDMT) use.
Behavioral Nudges as Patient Decision Support for Medication Adherence: The ENCOURAGE Randomized Controlled Trial. [2022]Medication adherence is generally low and challenging to address because patient actions control healthcare delivery outside of medical environments. Behavioral nudging changes clinician behavior, but nudging patient decision-making requires further testing. This trial evaluated whether behavioral nudges can increase statin adherence, measured as the proportion of days covered (PDC).
Designing Nudges for Success in Health Care. [2021]Nudges are subtle changes to the design of the environment or the framing of information that can influence our behaviors. There is significant potential to use nudges in health care to improve patient outcomes and transform health care delivery. However, these interventions must be tested and implemented using a systematic approach. In this article, we describe several ways to design nudges for success by focusing on optimizing and fitting them into the clinical workflow, engaging the right stakeholders, and rapid experimentation.
Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial. [2023]Annual influenza vaccination is widely recommended in older adults and other high-risk groups including patients with cardiovascular disease. The real-world effectiveness of influenza vaccination is limited by suboptimal uptake and effective strategies for increasing vaccination rates are therefore needed. The purpose of this trial is to investigate whether behavioral nudges digitally delivered via the Danish nationwide mandatory governmental electronic letter system can increase influenza vaccination uptake among older adults.
Why Health-enhancing Nudges Fail. [2023]Nudges are means to influence the will formation of people to make specific choices more likely. My focus is on nudges that are supposed to improve the health condition of individuals and populations over and above the direct prevention of disease. I point out epistemic and moral problems with these types of nudges, which lead to my conclusion that health-enhancing nudges fail. They fail because we cannot know which choices enhance individual health-properly understood in a holistic way-and because health-enhancing nudges are often themselves bad for our health. They can be bad for our health because they assume inferior agency in their targets and accordingly regularly lead to appropriate resentment and anger-strong emotions which go along with an increased risk of health impairments. Briefly, health-enhancing nudges fail because they are based on persistent ignorance and on a presumptuous attitude.
A 680,000-person megastudy of nudges to encourage vaccination in pharmacies. [2022]Encouraging vaccination is a pressing policy problem. To assess whether text-based reminders can encourage pharmacy vaccination and what kinds of messages work best, we conducted a megastudy. We randomly assigned 689,693 Walmart pharmacy patients to receive one of 22 different text reminders using a variety of different behavioral science principles to nudge flu vaccination or to a business-as-usual control condition that received no messages. We found that the reminder texts that we tested increased pharmacy vaccination rates by an average of 2.0 percentage points, or 6.8%, over a 3-mo follow-up period. The most-effective messages reminded patients that a flu shot was waiting for them and delivered reminders on multiple days. The top-performing intervention included two texts delivered 3 d apart and communicated to patients that a vaccine was "waiting for you." Neither experts nor lay people anticipated that this would be the best-performing treatment, underscoring the value of simultaneously testing many different nudges in a highly powered megastudy.
Nudging toward vaccination: a systematic review. [2021]Vaccine hesitancy (VH) and the global decline of vaccine coverage are a major global health threat, and novel approaches for increasing vaccine confidence and uptake are urgently needed. 'Nudging', defined as altering the environmental context in which a decision is made or a certain behaviour is enacted, has shown promising results in several health promotion strategies. We present a comprehensive synthesis of evidence regarding the value and impact of nudges to address VH.