Behavioral Economics to Improve Flu Vaccination Using EHR Nudges (BE IMMUNE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Flu; Behavior, Health; Flu Vaccination
• Intervention / Treatment: Behavioral: Pre-visit patient text messaging; Behavioral: Default pended order; Behavioral: Monthly peer comparison feedback; Behavioral: High risk bidirectional pre-visit 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, 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.

• Study Type: Interventional
• Enrollment (Actual): 80215
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shivan Mehta, MD,MBA,MSHP; Phone Number: 215-898-9807; Email: Shivan.Mehta@pennmedicine.upenn.edu
• Study Contact Backup: Name: Caitlin McDonald, MPH; Email: cmcdona@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
      • Contact: Andrew White, MD; Phone Number: 999-999-9999; Email: andwhite@uw.edu
      • Contact: Chaylin Couzens, MPH; Phone Number: 999-999-9999; Email: ccouzens@uw.edu
      • Principal Investigator: Joshua Liao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

All patients must meet the following criteria to be eligible:

1. Age >50 years
2. A scheduled new or return (non-urgent/sick) primary care appointment at one of the study practices at the Penn Medicine, UW Medicine, or Sutter Health
3. Have not received their annual flu vaccine during the active intervention period (September- February)
4. 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:

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

Patient Exclusion Criteria:

1. Have a documented allergy to flu vaccine
2. Have a flu vaccine exclusion modifier in Health Maintenance
3. Have opted out of research according to individual site guidelines and policies
4. 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:

1. Practicing physician (MD, DO) or advanced practice provider (NP, PA) with the exception of residents and fellows
2. Have a minimum patient panel of at least 50 patients, and
3. Practicing at a clinical site randomized to receive the clinic-level nudge interventions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Clinics randomized to the control arm will receive standard of care.
Experimental: Intervention Arm; 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; 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.; Behavioral: Default pended order; 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.; Behavioral: Monthly peer comparison feedback; 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.
Experimental: High Risk Intensification Arm; 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; 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.; Behavioral: Default pended order; 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.; Behavioral: Monthly peer comparison feedback; 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.; Behavioral: High risk bidirectional pre-visit text messaging; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA); University of Washington
• Investigators: Principal Investigator: Shivan Mehta, MD,MBA,MSHP, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Health Disparities; Behavioral Economics; Flu Vaccine Uptake; EHR Nudge
• Other Study ID Numbers: 851838; R33AG068945 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No