Behavioral Economics to Improve Flu Vaccination Using EHR Nudges

NCT06057727 | Completed Results DMC

• 2 other identifiers: 851838R33AG068945
• Study Type: interventional
• Target: 80,039
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Behavior, Health; Flu; Flu Vaccination

Keywords

Flu Vaccine Uptake; EHR Nudge; Behavioral Economics; Health Disparities

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  3 months

Study Arms (3)

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.

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.

Behavioral: Pre-visit patient text messaging; Behavioral: Default pended order; Behavioral: Monthly peer comparison feedback; Behavioral: High risk bidirectional pre-visit text messaging

Interventions

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 appointment and encouraging the patient to ask their provider about receiving the vaccine.

High Risk Intensification Arm; Intervention Arm

Default pended order BEHAVIORAL

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.

High Risk Intensification Arm; Intervention Arm

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 Intensification Arm; Intervention Arm

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).

High Risk Intensification Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have a documented allergy to flu vaccine
• Have opted out of research according to individual site guidelines and policies
• Have no phone number (home or mobile) listed in their chart
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator
• University of Washington: collaborator

Study Sites (2)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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 Jan 5:e257133. doi: 10.1001/jamainternmed.2025.7133. Online ahead of print.

  PMID: 41490010 DERIVED

• 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.

  PMID: 39557547 DERIVED

MeSH Terms

Conditions

Health Behavior; Influenza, Human

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Shivan Mehta
• Organization: University of Pennsylvania

shivan.mehta@pennmedicine.upenn.edu

2679726027

Study Officials

• Shivan Mehta, MD,MBA,MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Innovation Officer, Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 28, 2023
• Study Start: September 25, 2023
• Primary Completion: February 20, 2024
• Study Completion: May 20, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Within one year of trial completion
• Access Criteria: All inquiries related to the code should be directed to the PI.

Locations

US (2)