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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
| National Bureau of Economic Research, Inc. | OTHER |
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The purpose of this study is to test whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination.
The CDC recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. Past work from the study team focused on encouraging flu shots for patients with upcoming appointments. However, many patients in the health system do not have any appointments during flu season.
Eligible patients without an upcoming appointment will be randomized to a passive control group (no message), an active control group (a basic message stating that the patient can get a flu shot at Geisinger) or one of several other messages informed by behavioral science ("ease", "waiting for you", "protect yourself - rare outcomes", or "protect yourself - frequent outcomes"). Patients will be randomly assigned to one of several message send dates. Messages sent via patient portal, short message service (SMS) text, email, and/or another modality, will include a link redirecting patients to a page where they can self-schedule a flu shot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive control | No Intervention | No message | |
| Active control message | Active Comparator | A message that simply states that patients can get a flu shot at Geisinger |
|
| Ease message | Experimental | A message emphasizing the ease of scheduling a flu shot at Geisinger |
|
| Waiting for you message | Experimental | A message that states the patient's flu shot is "waiting" for them at Geisinger |
|
| Protect yourself - rare message | Experimental | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes |
|
| Protect yourself - frequent message | Experimental | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminder | Behavioral | Patient portal, SMS, email, and/or another modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Self-scheduled a Flu Shot | Patient self-schedules a flu vaccine appointment through the patient portal. This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date. | Within 4 weeks of message send date |
| Measure | Description | Time Frame |
|---|---|---|
| Flu Vaccination | Number of patients who received a flu vaccine | Within 4 weeks of message send date |
| Measure | Description | Time Frame |
|---|---|---|
| High Confidence Flu Diagnosis | Patient received a flu diagnosis via a positive PCR/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). | Up to 7 months |
| "Likely Flu" Diagnosis |
Inclusion Criteria:
Included in one or both of the following two base patient lists:
Aged 18 or older as of October 2022
Has had a Geisinger encounter in the last 2 years as of October 2022
Either of the following, as of October 2022:
Has not received a flu-shot during the 2022-23 flu season as of ~1 week prior to the message date (timeline may be slightly different, depending on data pull logistics), according to the Electronic Health Record (EHR)
Does not have a scheduled in-person primary care or in-person flu-shot-eligible specialty appointment in the 12 weeks following their assigned message send date, as of ~1 week prior to the message date (timelines may be slightly different, depending on data pull logistics or clinical guidance)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher F Chabris, PhD | Geisinger Clinic | Principal Investigator |
| Michelle N Meyer, PhD JD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
The data on the Open Science Framework will be open to anyone requesting that information.
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| ID | Title | Description |
|---|---|---|
| FG000 | Passive Control - November | No message |
| FG001 | Active Control Message - November | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG002 | Ease Message - November | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG003 | Waiting for You Message - November | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG004 | Protect Yourself - Rare Message - November | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| FG005 | Protect Yourself - Frequent Message - November | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| FG006 | Passive Control - December | No message |
| FG007 | Active Control Message - December | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG008 | Ease Message - December | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG009 | Waiting for You Message - December | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| FG010 | Protect Yourself - Rare Message - December | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| FG011 | Protect Yourself - Frequent Message - December | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Passive Control - November | No message |
| BG001 | Active Control Message - November | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Patients Who Self-scheduled a Flu Shot | Patient self-schedules a flu vaccine appointment through the patient portal. This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date. | Posted | Count of Participants | Participants | Within 4 weeks of message send date |
|
Adverse events were not monitored. See description.
This is a minimal risk study, and has received expedited IRB review in keeping with 45 CFR § 46.110. EHR and claims data will report inputs (i.e., the subject's assigned arm) and outcomes (i.e., flu vaccination, flu diagnosis, flu-like symptoms). We therefore did not monitor the data for AE/SAEs.
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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 | Passive Control - November | No message | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Rosenbaum | Geisinger | 570-243-1199 | grosenbaum@geisinger.edu |
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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 25, 2022 | Dec 28, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2023 | Jan 3, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D015438 | Health Behavior |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Although patients will not be explicitly informed of which arm they were randomized to, they will be aware of the messages they receive.
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|
Received a "high confidence flu" diagnosis (with positive polymerase chain reaction [PCR]/antigen/molecular test) and/or "likely flu" diagnosis (as assessed via International Classification of Disease [ICD] codes or Tamiflu administration or positive PCR/antigen/molecular test) (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023).
Note that "likely flu" is a superset of the "high confidence flu" diagnoses.
| Up to 7 months |
| Flu Complications | Diagnosed with flu-related complications (yes/no) from the patient's message send date through July 31, 2023. | Up to 10 months |
| ER Visits | Number of ER visits from the patient's message send date through July 31, 2023. | Up to 10 months |
| Hospitalizations | Number of hospitalizations from the patient's message send date through July 31, 2023. | Up to 10 months |
| COVID-19 Vaccination Rates | Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). | Up to 7 months |
| Number of Patients Who Self-Scheduled a Flu Shot by Sex | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | Within 4 weeks of the message send date |
| Number of Patients Who Self-Scheduled a Flu Shot by Race | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | Within 4 weeks of the message send date |
| Number of Patients Who Self-Scheduled a Flu Shot by Ethnicity | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | Within 4 weeks of the message send date |
| BG002 | Ease Message - November | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| BG003 | Waiting for You Message - November | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| BG004 | Protect Yourself - Rare Message - November | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| BG005 | Protect Yourself - Frequent Message - November | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| BG006 | Passive Control - December | No message |
| BG007 | Active Control Message - December | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| BG008 | Ease Message - December | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| BG009 | Waiting for You Message - December | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| BG010 | Protect Yourself - Rare Message - December | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| BG011 | Protect Yourself - Frequent Message - December | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| BG012 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Ease Message - November |
A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| OG003 | Waiting for You Message - November | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| OG004 | Protect Yourself - Rare Message | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| OG005 | Protect Yourself - Frequent Message - November | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| OG006 | Passive Control - December | No message |
| OG007 | Active Control Message - December | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| OG008 | Ease Message - December | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| OG009 | Waiting for You Message - December | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality |
| OG010 | Protect Yourself - Rare Message - December | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
| OG011 | Protect Yourself - Frequent Message - December | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality |
|
|
|
| Secondary | Flu Vaccination | Number of patients who received a flu vaccine | Posted | Count of Participants | Participants | Within 4 weeks of message send date |
|
|
|
| Other Pre-specified | High Confidence Flu Diagnosis | Patient received a flu diagnosis via a positive PCR/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). | Not Posted | Up to 7 months | Participants |
| Other Pre-specified | "Likely Flu" Diagnosis | Received a "high confidence flu" diagnosis (with positive polymerase chain reaction [PCR]/antigen/molecular test) and/or "likely flu" diagnosis (as assessed via International Classification of Disease [ICD] codes or Tamiflu administration or positive PCR/antigen/molecular test) (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). Note that "likely flu" is a superset of the "high confidence flu" diagnoses. | Not Posted | Up to 7 months | Participants |
| Other Pre-specified | Flu Complications | Diagnosed with flu-related complications (yes/no) from the patient's message send date through July 31, 2023. | Not Posted | Up to 10 months | Participants |
| Other Pre-specified | ER Visits | Number of ER visits from the patient's message send date through July 31, 2023. | Not Posted | Up to 10 months | Participants |
| Other Pre-specified | Hospitalizations | Number of hospitalizations from the patient's message send date through July 31, 2023. | Not Posted | Up to 10 months | Participants |
| Other Pre-specified | COVID-19 Vaccination Rates | Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). | Not Posted | Up to 7 months | Participants |
| Other Pre-specified | Number of Patients Who Self-Scheduled a Flu Shot by Sex | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | This outcome divides the population by sex (as listed in the electronic health record) | Posted | Count of Participants | Participants | Within 4 weeks of the message send date |
|
|
|
| Other Pre-specified | Number of Patients Who Self-Scheduled a Flu Shot by Race | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | This outcome divides the population by race (as listed in the electronic health record) | Posted | Count of Participants | Participants | Within 4 weeks of the message send date |
|
|
|
| Other Pre-specified | Number of Patients Who Self-Scheduled a Flu Shot by Ethnicity | Patient self-schedules a flu vaccine through the patient portal This outcome measures whether the patient schedules an appointment within 4 weeks of the message send date, but the appointment can occur more than 4 weeks past the send date. | This outcome divides the population by ethnicity (as listed in the electronic health record) | Posted | Count of Participants | Participants | Within 4 weeks of the message send date |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Active Control Message - November | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Ease Message - November | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Waiting for You Message - November | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Protect Yourself - Rare Message - November | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Protect Yourself - Frequent Message - November | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Passive Control - December | No message | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | Active Control Message - December | A message that simply states that patients can get a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG008 | Ease Message - December | A message emphasizing the ease of scheduling a flu shot at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Waiting for You Message - December | A message that states the patient's flu shot is "waiting" for them at Geisinger Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG010 | Protect Yourself - Rare Message - December | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
| EG011 | Protect Yourself - Frequent Message - December | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Reminder: Patient portal, SMS, email, and/or another modality | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Male |
|
|
|
| Asian |
|
|
| Native Hawaiian or Other Pacific Islander |
|
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| Black or African American |
|
|
| White |
|
|
| Two or More |
|
|
| Unknown |
|
|
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| Not Hispanic or Latino |
|
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| Unable to Obtain |
|
|