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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG068945 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-visit patient text messaging | 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 visit and encourage the patient to ask their provider about receiving the vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 days from enrollment, at the eligible visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
All patients must meet the following criteria to be eligible:
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:
Clinicians must meet the following criteria to be eligible to receive peer comparison feedback:
Exclusion Criteria:
Patients will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD, MBA, MSHP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
We will share our analytical code(s).
Within one year of trial completion.
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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
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients in clinics randomized to the control arm will receive standard of care. |
| FG001 | Intervention | Patients in clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be previsit text message reminders (standard messaging content). Clinician nudges will be monthly peer comparison feedback and default pended orders. No clinicians were individually enrolled as participants and no clinician outcomes were evaluated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Clinic Level Randomization |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2024 | Jan 22, 2026 |
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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.
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| Default pended order | Behavioral | 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. |
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| Monthly peer comparison feedback | 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 |
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| High risk bidirectional pre-visit text messaging | 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). |
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| FG002 | High Risk - Standard Messaging | Patients in the intervention clinics identified as high risk for noncompletion of the flu vaccine were randomized 1:1 to receive the high risk intensification messaging or remain in the standard messaging arm. Patients in the high risk standard messaging arm received the same standard messaging as average risk patients. |
| FG003 | High Risk - Intensification Messaging | Patients in the intervention clinics identified as high risk for noncompletion of the flu vaccine were randomized 1:1 to receive the high risk intensification messaging or remain in the standard messaging arm. Patients in the high risk intensification group received an additional bidirectional texting component in addition to the standard messaging. |
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| NOT COMPLETED |
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| Individual Randomization |
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Baseline characteristics are reported for the Main Study Period only - Clinic Level Randomization (Control and Intervention). Patients in the High Risk arms are accounted for in the Intervention arm as a whole, but were additionally randomized at the Individual Level, as noted in the Participant Flow. Baseline Characteristics were not assessed for clinicians as no clinician outcomes were evaluated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients in clinics randomized to the control arm will receive standard of care. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Lowest Quartile Income by Zip Code | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 4 days from enrollment, at the eligible visit |
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| 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. | Posted | Count of Participants | Participants | 3 months |
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Each patient was monitored for adverse events for 3 months. Adverse events were collected at the end of the trial follow up period, 3 months after enrollment ended (May 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death would result from outreach or communication to encourage flu vaccination. Therefore, All-Cause Mortality was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total. AEs were not monitored or assessed for clinicians.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients in clinics randomized to the control arm will receive standard of care. | 0 | 0 | 0 | 8,226 | 2 | 8,226 |
| EG001 | 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. | 0 | 0 | 0 | 18,022 | 502 | 18,022 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu Vaccine Reaction | Injury, poisoning and procedural complications | Systematic Assessment | Reaction requiring emergency department or hospital care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Messaging Opt-out | Social circumstances | Systematic Assessment | Patient frustration with messaging or outreach. Messaging opt-out was not assessed for control patients as they did not receive any messaging. |
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| Duplicate Vaccination | Surgical and medical procedures | Systematic Assessment | Duplicate flu vaccination within the recommended interval. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shivan Mehta | University of Pennsylvania | 2679726027 | shivan.mehta@pennmedicine.upenn.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2025 | Jan 22, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hispanic or Latino |
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| Lowest Income Quartile by Zip Code |
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Patients in the intervention clinics identified as high risk for noncompletion of the flu vaccine were randomized 1:1 to receive the high risk intensification messaging or remain in the standard messaging arm. Patients in the high risk intensification group received an additional bidirectional texting component in addition to the standard messaging. |
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