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Clinical Trials/NCT06626321
NCT06626321CompletedNot Applicable

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

University of Pennsylvania1 site in 1 country26,248 target enrollmentStarted: October 21, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26,248
Locations
1
Primary Endpoint
Proportion of patients who receive the flu vaccine at the visit

Study Overview

Brief Summary

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

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Pre-visit patient text messaging (Behavioral)

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.

Intervention: Default pended order (Behavioral)

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.

Intervention: Monthly peer comparison feedback (Behavioral)

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.

Intervention: Pre-visit patient text messaging (Behavioral)

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.

Intervention: Default pended order (Behavioral)

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.

Intervention: Monthly peer comparison feedback (Behavioral)

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.

Intervention: High risk bidirectional pre-visit text messaging (Behavioral)

Outcomes

Primary Outcomes

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

  • Proportion of patients who receive the flu vaccine within 3 months after the visit(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shivan J Mehta

Associate Chief Innovation Officer, Associate Professor of Medicine

University of Pennsylvania

Study Sites (1)

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