Behavior, HealthBE IMMUNENCT06057727

Behavioral Economics to Improve Flu Vaccination Using EHR Nudges

A study testing Pre-visit patient text messaging, Default pended order and Monthly peer comparison feedback in people with Behavior, Health and Flu, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Behavior, Health, Flu, Flu Vaccination
What is being tested?: Pre-visit patient text messaging, Default pended order and Monthly peer comparison feedback
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80,039 participants
Where: 2 sitesUnited States
Study dates: 25 Sep 2023to 20 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Patient Inclusion Criteria:

All 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 the Penn Medicine, UW Medicine, or Lancaster General Hospital
Have not received their annual flu vaccine during the active intervention period (September- February)
Eligible to receive the flu vaccine

For the high risk intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:

Age ≥ 70 years
Living in a lower income community (lowest quartile, zip-code based)
Did not receive a flu vaccine in the previous calendar year
Self-identifies as Non-Hispanic Black

Patient Exclusion Criteria:

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

Clinician Inclusion Criteria:

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, and
Practicing at a clinical site randomized to receive the clinic-level nudge interventions.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: BE IMMUNE: Behavioral Economics to IMprove and Motivate Vaccination Using Nudges Through the EHR

This study will be a multisite, cluster randomized, pragmatic 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 an additional, intensified nudge intervention 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.

Read the detailed description

Many older adults are at risk of illness, hospitalization, and death from vaccine-preventable diseases. More than half of older adults in the United States are not vaccinated for flu which has remained relatively constant over the past decade, and there are racial, ethnic, and socioeconomic disparities in care. In this study, we will evaluate personalized nudges to clinicians and patients to help increase flu vaccination rates during primary care visits among older adults, with a particular focus on population subgroups at high risk for vaccine noncompletion. In a partnership between Penn Medicine and University of Washington (UW) Medicine, this will be a 6-month, multisite, cluster randomized, pragmatic trial with an additional intensification arm for high-risk patients.

Conditions: Behavior, Health, Flu, Flu Vaccination
Being tested: Pre-visit patient text messaging, Default pended order, Monthly peer comparison feedback, High risk bidirectional pre-visit text messaging
Keywords: Flu Vaccine Uptake, EHR Nudge, Behavioral Economics, Health Disparities
Medical subject headings: Health Behavior, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre-visit patient text messagingBehavioural
Patients will be sent text message reminders 3 days and 24 hours prior to their scheduled primary care visit. The messages will inform the patient that a flu shot has been reserved for them at their upcoming appointment and encouraging the patient to ask their provider about receiving the vaccine.
Default pended orderBehavioural
A default pended order for the flu vaccine will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.
Monthly peer comparison feedbackBehavioural
Each month, clinicians will be sent an email containing what percent of their eligible patients received the flu vaccine and how that compares to other peer clinicians in the intervention.
High risk bidirectional pre-visit text messagingBehavioural
High risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component prior to their visit. This intervention will query the patient about common questions or concerns about receiving the flu vaccine. If the patient responds, it will provide additional educational materials based on the patient's specific concern(s).

Study groups in NCT06057727
Study group	Role	What they receive
Control	No intervention	Clinics randomized to the control arm will receive standard of care.
Intervention Arm	Experimental	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. Receives: Behavioral: Pre-visit patient text messaging; Behavioral: Default pended order; Behavioral: Monthly peer comparison feedback
High Risk Intensification Arm	Experimental	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. Receives: Behavioral: Pre-visit patient text messaging; Behavioral: Default pended order; Behavioral: Monthly peer comparison feedback; Behavioral: High risk bidirectional pre-visit text messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Who Receive the Flu Vaccine at the Visit
The primary outcome is flu vaccination completion during the first eligible primary care visit.
Measured: 4 days from enrollment, at the eligible visit

Secondary outcomes (1)

Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit
The secondary outcome is flu vaccination completion within 3 months after the first eligible primary care visit.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202320 May 2024

First posted28 Sep 2023
Study start25 Sep 2023
Primary completion20 Feb 2024
Study completion20 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Behavior, HealthStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: We will randomize primary care clinics 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of the flu vaccine will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 80,039 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06057727
Sponsor's protocol ID: 851838
Other IDs: R33AG068945
Acronym: BE IMMUNE
Status last verified: Apr 2025
First submitted: 18 Sep 2023
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share our analytical code(s).

Publications

Mehta SJ, Waddell KJ, Linn KA, Brophy C, Liang J, Park SH, Reitz C, Williams K, Couzens C, Staloff J, White AA, Rhodes C, Liao JM, Navathe AS. Nudges to Clinicians and Patients for Influenza Vaccines During Visits: The BE IMMUNE Randomized Clinical Trial. JAMA Intern Med. 2026 Mar 1;186(3):304-310. doi: 10.1001/jamainternmed.2025.7133.
PubMed 41490010
Waddell K, Mehta SJ, Navathe A, Linn K, Park SH, White A, Staloff J, Rhodes C, Couzens C, Goel K, McDonald C, Reitz C, Williams K, Liao JM. 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. BMJ Open. 2024 Nov 18;14(11):e086698. doi: 10.1136/bmjopen-2024-086698.
PubMed 39557547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BE IMMUNE: Behavioral Economics to IMprove and Motivate Vaccination Using Nudges Through the EHR
ClinicalTrials.gov ID: NCT06057727
Acronym / sponsor ID: BE IMMUNE / 851838
Conditions: Behavior, Health, Flu, Flu Vaccination
Keywords: Flu Vaccine Uptake, EHR Nudge, Behavioral Economics, Health Disparities
Study type: Interventional
Recruitment status: Completed
Enrolment: 80,039 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), University of Washington
Study start: 25 Sep 2023 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 20 May 2024 (actual)
First posted: 28 Sep 2023 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: We will randomize primary care clinics 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of the flu vaccine will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone.

Arm	Type	Receives
Control	No intervention	–Clinics randomized to the control arm will receive standard of care.
Intervention Arm	Experimental	Behavioral: Pre-visit patient text messaging, Behavioral: Default pended order, Behavioral: Monthly peer comparison feedbackClinics 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.
High Risk Intensification Arm	Experimental	Behavioral: Pre-visit patient text messaging, Behavioral: Default pended order, Behavioral: Monthly peer comparison feedback, Behavioral: High risk bidirectional pre-visit text messagingPatients 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pre-visit patient text messagingPatients will be sent text message reminders 3 days and 24 hours prior to their scheduled primary care visit. The messages will inform the patient that a flu shot has been reserved for them at their upcoming appointment and encouraging the patient to ask their provider about receiving the vaccine.	Behavioural	High Risk Intensification Arm, Intervention Arm
Default pended orderA default pended order for the flu vaccine will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.	Behavioural	High Risk Intensification Arm, Intervention Arm
Monthly peer comparison feedbackEach month, clinicians will be sent an email containing what percent of their eligible patients received the flu vaccine and how that compares to other peer clinicians in the intervention.	Behavioural	High Risk Intensification Arm, Intervention Arm
High risk bidirectional pre-visit text messagingHigh risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component prior to their visit. This intervention will query the patient about common questions or concerns about receiving the flu vaccine. If the patient responds, it will provide additional educational materials based on the patient's specific concern(s).	Behavioural	High Risk Intensification Arm

Primary outcome

Proportion of Patients Who Receive the Flu Vaccine at the Visit
Time frame: 4 days from enrollment, at the eligible visit
The primary outcome is flu vaccination completion during the first eligible primary care visit.

1 secondary outcome

Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit
Time frame: 3 months

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	27,513	27,513
Intervention	52,526	52,526
High Risk - Standard Messaging	0	0
High Risk - Intensification Messaging	0	0
High Risk - Not Individually Randomized	0	0

Primary outcome: Proportion of Patients Who Receive the Flu Vaccine at the Visit

Time frame: 4 days from enrollment, at the eligible visit. Count of participants. Unit: Participants

Measure	Control n = 27513	Intervention n = 52526	High Risk - Standard Messaging n = 20440	High Risk - Intensification Messaging n = 20412	High Risk - Not Individually Randomized n = 1057
Value	7305	16663	6142	6142	312

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each patient was monitored for adverse events for 3 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through the end of December 2023 and again at the end of the trial follow up period, 3 months after enrollment ended (May 2024), for all enrolled participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 27,513 (0%)	5 of 27,513 (0%)	0
Intervention	1 of 52,526 (0%)	817 of 52,526 (1.6%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41490010Mehta SJ, Waddell KJ, Linn KA, Brophy C, Liang J, Park SH, Reitz C, Williams K, Couzens C, Staloff J, White AA, Rhodes C, Liao JM, Navathe AS. Nudges to Clinicians and Patients for Influenza Vaccines During Visits: The BE IMMUNE Randomized Clinical Trial. JAMA Intern Med. 2026 Mar 1;186(3):304-310. doi: 10.1001/jamainternmed.2025.7133.
Derived from this study: PubMed 39557547Waddell K, Mehta SJ, Navathe A, Linn K, Park SH, White A, Staloff J, Rhodes C, Couzens C, Goel K, McDonald C, Reitz C, Williams K, Liao JM. 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. BMJ Open. 2024 Nov 18;14(11):e086698. doi: 10.1136/bmjopen-2024-086698.
Individual participant dataSharing planned: Yes. We will share our analytical code(s).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shivan Mehta, MD,MBA,MSHP principal investigator

University of Pennsylvania

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Receive the Flu Vaccine at the Visit (time frame: 4 days from enrollment, at the eligible visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057727, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.