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

26249 Participants Needed

Trial Summary

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 Behavioral Economics for increasing flu shot uptake?

Research shows that behavioral nudges, like text reminders and default appointments, can effectively increase flu vaccination rates. For example, text reminders increased vaccination rates by 2% in a large study, and default appointments boosted rates by 10% in a medical practice. ^{1 2 3 4 5}

Is it safe for humans to participate in clinical trials involving behavioral nudges to increase flu shot uptake?

Behavioral nudges, such as text reminders and default appointments, have been used in large studies to increase flu vaccination rates without any reported safety concerns for participants. ^{1 2 4 5 6}

How does the treatment Behavioral Economics differ from other treatments for increasing flu shot uptake?

Behavioral Economics uses 'nudges' like reminders and default appointments to encourage people to get flu shots, which is different from traditional methods that rely on direct persuasion or incentives. This approach leverages subtle psychological cues to influence decision-making, making it a unique and innovative way to increase vaccination rates. ^{1 2 3 4 6}

What is the purpose of this trial?

This study will be a 6-month, cluster randomized, pragmatic replication trial to evaluate the effectiveness of personalized nudges to clinicians and patients, relative to a control, to increase flu vaccination rates among older adults in accordance with CDC guidelines. This will include clinician and patient level nudge interventions, with additional, intensified nudge interventions for patients identified as high risk for not receiving a flu vaccine. Among the intervention clinics, patients will receive pre-visit text message reminders about the flu vaccine, and clinicians will receive a default pended order in the visit encounter in the EHR, along with monthly peer comparison feedback about their flu vaccine completion rate. Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging

Research Team

Shivan Mehta, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Default clinic appointments promote influenza vaccination uptake without a displacement effect. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Nudging influenza vaccination among health care workers. [2021]

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

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

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

A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. [2023]

6. 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]