Clinical trial NCT06626321: Behavioral Economics to Improve Flu Vaccination Using EHR Nudges Replication
Official title: BE IMMUNE: Behavioral Economics to IMprove and Motivate Vaccination Using Nudges Through the EHR, A Replication Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavior, Health
Flu
Flu Vaccination
Keywords: Flu Vaccine Uptake
EHR Nudge
Behavioral Economics
Health Disparities
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-03
Enrollment: 26249
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize clinics 2:1 to the nudge arm or control arm using covariate-constrained randomization. Within the high-risk patient subgroups, stratifying by intervention clinics, patients will be randomized 1:1 in Way to Health using permuted block randomization using random block sizes of 2, 4, and 6 to receive the additional intensification bidirectional text messaging nudge or standard messaging.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 Lancaster General 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 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:

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:

Patients will be excluded from the study if they:

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

Primary outcomes:
measure: Proportion of patients who receive the flu vaccine at the visit
timeFrame: 4 days from enrollment, at the eligible visit
Secondary outcomes:
measure: Proportion of patients who receive the flu vaccine within 3 months after the visit
timeFrame: 3 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD, MBA, MSHP
role: PRINCIPAL_INVESTIGATOR
References: