Behavior, Health, Flu, Flu Vaccination
Conditions
Keywords
Flu Vaccine Uptake, EHR Nudge, Behavioral Economics, Health Disparities
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.
Interventions
BEHAVIORALPre-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 visit and encourage the patient to ask their provider about receiving the vaccine.
BEHAVIORALDefault pended order
A default pended order for the flu vaccine will be pended to the patients 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.
BEHAVIORALMonthly 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 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).
Sponsors
University of Pennsylvania
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Receive the Flu Vaccine at the Visit | 4 days from enrollment, at the eligible visit | The primary outcome is flu vaccination completion during the first eligible primary care visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 3 months | The secondary outcome is flu vaccination completion within 3 months after the first eligible primary care visit. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShivan Mehta, MD, MBA, MSHP
University of Pennsylvania
Participant flow
Recruitment details
Waiver of informed consent obtained. Patients were identified via Epic Clarity Query 4 days prior to their eligible primary care visit between October 21, 2024 - February 28, 2025. Patients were only counted once within the study window at their first primary care visit. Total protocol enrollment: 26,248 patients. No clinicians were individually enrolled as participants and no clinician outcomes were evaluated.
Pre-assignment details
Clinics were randomized 2:1 to intervention and control. Patients seen at an intervention clinic and identified as high risk were further randomized 1:1 to standard messaging or an intensification nudge. The high risk individual randomization is nested within the intervention arm resulting in an overlap of patients where high risk individuals (15,163 of the 18,022) contribute both to estimation of the overall intervention effect and comparison of text messaging intensity among high risk patients
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.99 years STANDARD_DEVIATION 10.8 |
| Lowest Quartile Income by Zip Code Above Lowest Income Quartile by Zip Code | 13529 Participants |
| Lowest Quartile Income by Zip Code Lowest Income Quartile by Zip Code | 2561 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1193 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino/Unknown | 16829 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 37 Participants |
| Race (NIH/OMB) Asian | 358 Participants |
| Race (NIH/OMB) Black or African American | 891 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1409 Participants |
| Race (NIH/OMB) White | 7400 Participants |
| Sex: Female, Male Female | 9416 Participants |
| Sex: Female, Male Male | 3958 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2 / 8,226 | 502 / 18,022 |
| serious Total, serious adverse events | 0 / 8,226 | 0 / 18,022 |
Outcome results
None listed