Behavior, Health, Flu, Flu Vaccination
Conditions
Keywords
Flu Vaccine Uptake, EHR Nudge, Behavioral Economics, Health Disparities
Brief 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.
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, 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.
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 appointment and encouraging 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 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.
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
National Institute on Aging (NIA)
University of Washington
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 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 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.
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
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 September 25, 2023 - February 20, 2024. Patients were only counted once within the study window at their first primary care visit. Total protocol enrollment: 80,039 patients.
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 (41,909 of the 52,526) contribute both to estimation of the overall intervention effect and comparison of text messaging intensity among high risk patients
Participants by arm
| Arm | Count |
|---|---|
| Control Patients in clinics randomized to the control arm will receive standard of care. | 27,513 |
| Intervention Patients in 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. | 52,526 |
| Total | 80,039 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 10.3 | 65.8 years STANDARD_DEVIATION 10.2 | 65.1 years STANDARD_DEVIATION 10 |
| Lowest Quartile Income by Zip Code Above Lowest Income Quartile by Zip Code | 37064 Participants | 56470 Participants | 19406 Participants |
| Lowest Quartile Income by Zip Code Lowest Income Quartile by Zip Code | 15462 Participants | 23569 Participants | 8107 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1793 Participants | 3145 Participants | 1352 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino/ Unknown | 50733 Participants | 76894 Participants | 26161 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 266 Participants | 404 Participants | 138 Participants |
| Race (NIH/OMB) Asian | 3412 Participants | 5579 Participants | 2167 Participants |
| Race (NIH/OMB) Black or African American | 11928 Participants | 18695 Participants | 6767 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 144 Participants | 279 Participants | 135 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3138 Participants | 4910 Participants | 1772 Participants |
| Race (NIH/OMB) White | 33638 Participants | 50172 Participants | 16534 Participants |
| Sex/Gender, Customized Female | 29640 Participants | 44802 Participants | 15162 Participants |
| Sex/Gender, Customized Male | 22747 Participants | 34875 Participants | 12128 Participants |
| Sex/Gender, Customized Unknown | 139 Participants | 362 Participants | 223 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 | 5 / 27,513 | 817 / 52,526 |
| serious Total, serious adverse events | 0 / 27,513 | 1 / 52,526 |
Outcome results
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.
Time frame: 4 days from enrollment, at the eligible visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Proportion of Patients Who Receive the Flu Vaccine at the Visit | 7305 Participants |
| Intervention | Proportion of Patients Who Receive the Flu Vaccine at the Visit | 16663 Participants |
| High Risk - Standard Messaging | Proportion of Patients Who Receive the Flu Vaccine at the Visit | 6142 Participants |
| High Risk - Intensification Messaging | Proportion of Patients Who Receive the Flu Vaccine at the Visit | 6142 Participants |
| High Risk - Not Individually Randomized | Proportion of Patients Who Receive the Flu Vaccine at the Visit | 312 Participants |
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 9371 Participants |
| Intervention | Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 19892 Participants |
| High Risk - Standard Messaging | Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 7329 Participants |
| High Risk - Intensification Messaging | Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 7371 Participants |
| High Risk - Not Individually Randomized | Proportion of Patients Who Receive the Flu Vaccine Within 3 Months After the Visit | 385 Participants |