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OpenTrials
Completed

NCT Number: NCT06626321

Behavioral Economics to Improve Flu Vaccination Using EHR Nudges Replication

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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:

  • 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.

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

Treatment and study plan

Pre-visit patient text messaging

Behavioral

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 order

Behavioral

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 feedback

Behavioral

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 messaging

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit

    Time frame: 3 months

    The secondary outcome is flu vaccination completion within 3 months after the first eligible primary care visit.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

BE IMMUNE: Behavioral Economics to IMprove and Motivate Vaccination Using Nudges Through the EHR, A Replication Trial

Acronym: BE IMMUNE Rep

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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