Behavioral Nudges for Flu Shot Uptake

(BE IMMUNE Rep Trial)

Overseen By Shivan Mehta, MD, MBA, MSHP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Flu vaccine allergy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if personalized reminders can increase flu vaccination rates among older adults. By sending text message reminders to patients and providing doctors with feedback on vaccination rates, the researchers hope to encourage more people to get their flu shots. This approach draws on principles of Behavioral Economics, which examines how psychological factors influence economic decision-making. Individuals with a primary care appointment at Lancaster General Health who have not yet received a flu vaccine may be eligible for this trial. Those at high risk, such as residents of lower-income areas or those who missed last year's flu shot, may receive additional reminders. As an unphased trial, this study offers a unique opportunity to contribute to innovative research aimed at improving public health.

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 these behavioral nudges are safe for increasing flu vaccination rates?

Research has shown that simple reminders, such as text messages, can safely increase flu vaccination rates. In one study, these reminders led to more people getting vaccinated without harmful effects. Another study found that text reminders slightly increased vaccination rates among pregnant women, again with no safety issues. These reminders work by sending clear messages to both patients and healthcare providers, prompting them to remember flu shots. Overall, studies indicate these reminders are well-received and have not caused serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how behavioral nudges can improve flu shot uptake, a fresh angle compared to traditional reminders and advertising. The intervention arm uses a combination of text message reminders for patients and peer comparison feedback for clinicians to encourage vaccinations. Moreover, the high-risk intensification arm adds a bidirectional texting feature for patients less likely to complete their flu shots, providing a more personalized and interactive approach. This trial aims to discover if these behavioral economics strategies can significantly boost vaccination rates by engaging both patients and healthcare providers in a new way.

What evidence suggests that these behavioral nudges are effective for increasing flu vaccination rates?

Research has shown that simple reminders, such as text messages and automatic appointment scheduling, can increase flu vaccination rates. In this trial, clinics in the intervention arm will receive a toolkit of clinician and patient-facing nudges, including pre-visit text message reminders and clinician feedback. One study found that text reminders increased flu shot rates from 26.2% to 38.6%. For those at high risk, the high-risk intensification arm in this trial will include additional bidirectional texting, which has shown small improvements in other studies, particularly when many people were already getting vaccinated. The evidence suggests these reminders can significantly boost flu vaccination rates. ^{1 6 7 8 9}

Who Is on the Research Team?

Shivan Mehta, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for older adults who are due to receive their flu vaccine, following CDC guidelines. It's designed to see if reminders and prompts (nudges) can help increase vaccination rates. People in the study will get text messages or have orders set up in their health records to remind them.

Inclusion Criteria

Patients must meet the following criteria to be eligible: Age ≥ 50 years, A scheduled new or return (non-urgent/sick) primary care appointment at one of the study practices at Lancaster General Health, Have not received their annual flu vaccine during the active intervention period (September- February), Eligible to receive the flu vaccine

Clinicians must meet the following criteria to be eligible to receive peer comparison feedback: Practicing physician (MD, DO) or advanced practice provider (NP, PA) with the exception of residents and fellows, Have a minimum patient panel of at least 50 patients, Practicing at a clinical site randomized to receive the clinic-level nudge interventions.

I am over 70, live in a low-income area, didn't get last year's flu shot, or I am Non-Hispanic Black.

Exclusion Criteria

Patients will be excluded from the study if they: Have a documented allergy to flu vaccine, Have a flu vaccine exclusion modifier in Health Maintenance, Have opted out of research according to individual site guidelines and policies, Have no phone number (home or mobile) listed in their chart

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinics receive clinician and patient facing nudges, including pre-visit text message reminders and monthly peer comparison feedback for clinicians. High-risk patients receive additional bidirectional texting.

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for flu vaccination completion within 3 months after the first eligible primary care visit

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Economics

Trial Overview The study tests whether different types of 'nudges' like pre-visit texts and monthly feedback to clinicians can boost flu shot numbers. Some high-risk patients will get extra nudges. Clinics are randomly chosen for standard reminders or these intensified efforts.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 3 Interventions

Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be pre-visit text message reminders (standard messaging content). Clinician nudges will be monthly peer comparison feedback and default pended orders.

Group II: High Risk Intensification Arm Experimental Treatment 4 Interventions

Patients in the intervention clinics identified as high risk for noncompletion of the flu vaccine will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.

Group III: Control Active Control 1 Intervention

Clinics randomized to the control arm will receive standard of care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A nationwide trial in Denmark involving over 964,000 older adults showed that electronic letters emphasizing the cardiovascular benefits of influenza vaccination significantly increased vaccination rates compared to usual care, with a notable increase of 0.89 percentage points.

The use of repeated electronic reminders also improved vaccination uptake, demonstrating that simple, low-cost behavioral nudges can effectively enhance public health initiatives, especially among those who were previously unvaccinated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. Johansen, ND., Vaduganathan, M., Bhatt, AS., et al.[2023]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06057727

Behavioral Economics to Improve Flu Vaccination Using ... In this study, we will evaluate personalized nudges to clinicians and patients to help increase flu vaccination rates during primary care visits among older ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11574401/

Behavioural economics to improve and motivate ... The purpose of this trial is to evaluate multicomponent behavioural economic nudge interventions to clinicians and patients to increase influenza vaccination.

3. withpower.com withpower.com/trial/phase-flu-vaccination-9-2024-6c3bf

Behavioral Nudges for Flu Shot Uptake · Info for Participants Research shows that behavioral nudges, like text reminders and default appointments, can effectively increase flu vaccination rates. For example, text reminders ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06057727?keyword=%22Flu%22

Behavioral Economics to Improve Flu Vaccination Using ... This study will be a multisite, cluster randomized, pragmatic trial to evaluate the effectiveness of personalized nudges to clinicians and patients, ...

5. researchgate.net researchgate.net/publication/385918782_Behavioural_economics_to_improve_and_motivate_vaccination_in_primary_care_using_nudges_through_the_electronic_health_record_rationale_and_design_of_the_BE_IMMUNE_randomised_clinical_trial

(PDF) Behavioural economics to improve and motivate ... Purpose To evaluate if nudges delivered by text message prior to an upcoming primary care visit can increase influenza vaccination rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10798571/

A Randomized Trial of Behavioral Nudges Delivered ... Among the interventions, 5 of 19 (26.3%) had a significantly greater vaccination rate than the control group using a B-H adjusted threshold of P < .05. On ...

7. pnas.org pnas.org/doi/10.1073/pnas.2115126119

A 680000-person megastudy of nudges to encourage ... We tested 22 different text reminders using a variety of different behavioral science principles to nudge flu vaccination. Reminder texts increased vaccination ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/14/11/e086698

Behavioural economics to improve and motivate ... The purpose of this trial is to evaluate multicomponent behavioural economic nudge interventions to clinicians and patients to increase influenza vaccination.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25007741

Randomised controlled trials of behavioural nudges ... The nudges delivered via SMS resulted in small increases in COVID-19 and influenza vaccination uptake among pregnant women.