Behavior, HealthBE IMMUNE RepNCT06626321
Behavioral Economics to Improve Flu Vaccination Using EHR Nudges Replication
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 1 site in United States.
Trial summary
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. Read more about this study
- 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
- 26,248 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 28 May 2025
- 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
Who may be able to join
- 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 Lancaster General Health
- Have not received their annual flu vaccine during the active intervention period (September- February)
- Eligible to receive the flu vaccine
- For the patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
Show all 14Show fewer
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Health
Lancaster, Pennsylvania, 17602
About this study
Official title: BE IMMUNE: Behavioral Economics to IMprove and Motivate Vaccination Using Nudges Through the EHR, A Replication 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
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 at three distinct health systems, 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, a 6-month, multisite, cluster randomized, pragmatic trial with an additional intensification arm for high-risk patients was conducted from September 2023-February 2024. We will now conduct a 6-month replication trial at Lancaster General Health for the 2024-2025 flu season.
- 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 visit and encourage 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 patients 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 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.
- First posted3 Oct 2024
- Study start21 Oct 2024
- Primary completion28 Feb 2025
- Study completion28 May 2025
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.
- 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 clinics 2:1 to the nudge arm or control arm using covariate-constrained randomization. Within the high-risk patient subgroups, stratifying by intervention clinics, patients will be randomized 1:1 in Way to Health using permuted block randomization using random block sizes of 2, 4, and 6 to receive the additional intensification bidirectional text messaging nudge or standard messaging.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, MD, MBA, MSHP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626321
- Sponsor's protocol ID
- 856739
- Other IDs
- R33AG068945
- Acronym
- BE IMMUNE Rep
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2024
- Last updated
- 30 Mar 2026
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. 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, A Replication Trial
- ClinicalTrials.gov ID
- NCT06626321
- Acronym / sponsor ID
- BE IMMUNE Rep / 856739
- Conditions
- Behavior, Health, Flu, Flu Vaccination
- Keywords
- Flu Vaccine Uptake, EHR Nudge, Behavioral Economics, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,248 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Posted 30 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 at three distinct health systems, 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, a 6-month, multisite, cluster randomized, pragmatic trial with an additional intensification arm for high-risk patients was conducted from September 2023-February 2024. We will now conduct a 6-month replication trial at Lancaster General Health for the 2024-2025 flu season.
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 clinics 2:1 to the nudge arm or control arm using covariate-constrained randomization. Within the high-risk patient subgroups, stratifying by intervention clinics, patients will be randomized 1:1 in Way to Health using permuted block randomization using random block sizes of 2, 4, and 6 to receive the additional intensification bidirectional text messaging nudge or standard messaging.
| 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
Key inclusion criteria (14 listed)
- 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
- For the patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
Key exclusion criteria (5 listed)
- 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
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 visit and encourage 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 patients 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will share our analytical code(s).
Related trials for Behavior, Health
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Mar 2026). 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?
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 30 Mar 2026.