Behavioral Economics to Improve Flu Vaccination Using EHR Nudges

Behavior, Health Clinical Trial

— BE IMMUNE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06057727
• Other study ID #: 851838
• Secondary ID: R33AG068945
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80215
• Est. completion date: May 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Flu

Intervention

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.
• 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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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