Behavioral Economics to Improve Flu Vaccination Using EHR Nudges

NCT ID: NCT06057727

Last Updated: 2025-04-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80039 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2024-05-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Behavior, Health Flu Flu Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Clinics randomized to the control arm will receive standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Pre-visit patient text messaging

Intervention Type 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.

Default pended order

Intervention Type 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.

Monthly peer comparison feedback

Intervention Type 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

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.

Group Type EXPERIMENTAL

Pre-visit patient text messaging

Intervention Type 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.

Default pended order

Intervention Type 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.

Monthly peer comparison feedback

Intervention Type 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

Intervention Type 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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 Lancaster General Hospital
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


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.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Shivan J Mehta

Associate Chief Innovation Officer, Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shivan Mehta, MD,MBA,MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39557547 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R33AG068945

Identifier Type: NIH

Identifier Source: secondary_id

View Link

851838

Identifier Type: -

Identifier Source: org_study_id

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