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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG034532 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
| Massachusetts Institute of Technology | OTHER |
| National Institute on Aging (NIA) | NIH |
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The study team previously demonstrated that patients are more likely to receive flu vaccine after learning that they are at high risk for flu complications. Building on this past work, the present study will explore whether providing reasons that patients are considered high risk for flu complications (a) further increases the likelihood they will receive flu vaccine and (b) decreases the likelihood that they receive diagnoses of flu and/or flu-like symptoms in the ensuing flu season. It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving the flu vaccine or diagnoses of flu and/or flu-like symptoms.
Geisinger has partnered with Medial EarlySign and developed an ML algorithm to identify patients at risk for serious (moderate to severe) flu-associated complications on the basis of their existing electronic health record (EHR) data. Geisinger will apply this algorithm to current patients during the 2021-22 flu season.
This study will evaluate the effect of contacting patients identified as high risk with special messages to encourage vaccination. These communications will inform patients they are at high risk with either (a) no additional explanation, (b) an explanation that this determination comes from an analysis of their medical records, along with a short list of the top factors from their medical record that explain their risk, and (c) the additional explanation that an AI or ML algorithm made this determination, along with a short list of the top factors from their medical record that explain their risk.
Included in the study will be current Geisinger patients 18+ years of age with no contraindications for flu vaccine and who have been assessed by the Medial algorithm and assigned a risk score. The primary study outcomes will be the rates of flu vaccination and flu diagnosis during the 2020-21 season by targeted patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-Contact Control | No Intervention | Subjects in the no-contact control arm will receive no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a conventional non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted. | |
| Reminder Control | Experimental | Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. |
|
| High Risk Only | Experimental | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. |
|
| High Risk with Explanation Based on Medical Records | Experimental | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminder | Behavioral | Mailed letter, short message service (SMS) text, and/or patient portal message |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flu Vaccination at 2 Weeks After Final Outreach Date | Received flu vaccination | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
| Measure | Description | Time Frame |
|---|---|---|
| Flu Vaccination at 9 Weeks After Final Outreach Date | Received a flu vaccination | Within 9 weeks of the final outreach date, 106 days (15.14 weeks) after the study start |
| 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) Note that "likely flu" is a superset of the "high confidence flu" diagnoses. |
| Measure | Description | Time Frame |
|---|---|---|
| Flu Vaccination at 2 Weeks After Final Outreach Date by Gender | Received a flu vaccination | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
| Flu Vaccination at 2 Weeks After Final Outreach Date by Race |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle N Meyer, PhD JD | Geisinger Clinic | Principal Investigator |
| Christopher F Chabris, PhD | 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 and code are available in the below repository in the folder ClinicalTrials.gov data/Study 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | No-Contact Control | Subjects in the no-contact control arm will receive no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a conventional non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted. |
| FG001 | Reminder Control | Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message |
| FG002 | High Risk Only | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message |
| FG003 | High Risk With Explanation Based on Medical Records | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message |
| FG004 | High Risk With Explanation Based on Algorithm | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message Algorithm-based recommendation: Mailed letter, SMS, and/or patient portal message |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No-Contact Control | Subjects in the no-contact control arm will receive no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a conventional non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted. |
| 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 | Flu Vaccination at 2 Weeks After Final Outreach Date | Received flu vaccination | Patients were excluded from analyses if they died before or during the study, if they were contraindicated for flu vaccine, if they were sent protective risk reasons, or if they were vaccinated prior to the study beginning. See the Statistical Analysis Plan for more information on exclusions. | Posted | Count of Participants | Participants | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
|
Roughly 1 month (9/9/21 - 10/7/21)
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. However, on 10/7/2021, we completed a data pull with an updated death record check, and patients who died during the study as of that data pull are indicated under All-Cause Mortality.
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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 | No-Contact Control | Subjects in the no-contact control arm will receive no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a conventional non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Rosenbaum | Geisinger | 800-275-6401 | 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 | Jun 28, 2021 | Nov 4, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2021 | Nov 10, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D015438 | Health Behavior |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D061366 | Numbers Needed To Treat |
| ID | Term |
|---|---|
| D018401 | Sample Size |
| D012107 | Research Design |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Patients from the high-risk sample will be randomly assigned to one of five arms:
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Providers who prescribe vaccination and diagnose conditions will not be randomized to study arms or informed of patient assignment. Although patients will not be explicitly informed which arm they have been randomized to, they will be aware of the messages they receive.
| High Risk with Explanation Based on Algorithm | Experimental | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. |
|
| Risk reduction | Behavioral | Mailed letter, SMS, and/or patient portal message |
|
| Medical records-based recommendation | Behavioral | Mailed letter, SMS, and/or patient portal message |
|
|
| Algorithm-based recommendation | Behavioral | Mailed letter, SMS, and/or patient portal message |
|
|
| 8 months (between September 9, 2021 and April 30, 2022) |
| Flu Complications | Diagnosed with flu-related complications | 11 months (between September 9, 2021 and July 31, 2022) |
| Healthcare Utilization | Visited ER or was hospitalized NOTE: Our prespecified outcome was description was "Visited ER, was hospitalized, or had flu-related insurance claims." We did not receive claims data, so this outcomes includes only ER visits and hospitalizations. | 11 months (between September 9, 2021 and July 31, 2022) |
Received Flu Vaccination
| Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
| Flu Vaccination at 2 Weeks After Final Outreach Date by Ethnicity | Received flu vaccination | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
| Death |
|
| BG001 | Reminder Control | Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message |
| BG002 | High Risk Only | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message |
| BG003 | High Risk With Explanation Based on Medical Records | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message |
| BG004 | High Risk With Explanation Based on Algorithm | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message Algorithm-based recommendation: Mailed letter, SMS, and/or patient portal message |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Reminder Control | Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message |
| OG002 | High Risk Only | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message |
| OG003 | High Risk With Explanation Based on Medical Records | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message |
| OG004 | High Risk With Explanation Based on Algorithm | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message Algorithm-based recommendation: Mailed letter, SMS, and/or patient portal message |
|
|
|
| Secondary | Flu Vaccination at 9 Weeks After Final Outreach Date | Received a flu vaccination | Posted | Count of Participants | Participants | Within 9 weeks of the final outreach date, 106 days (15.14 weeks) after the study start |
|
|
|
| Secondary | 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) Note that "likely flu" is a superset of the "high confidence flu" diagnoses. | Posted | Count of Participants | Participants | 8 months (between September 9, 2021 and April 30, 2022) |
|
|
|
| Secondary | Flu Complications | Diagnosed with flu-related complications | Posted | Count of Participants | Participants | 11 months (between September 9, 2021 and July 31, 2022) |
|
|
|
| Secondary | Healthcare Utilization | Visited ER or was hospitalized NOTE: Our prespecified outcome was description was "Visited ER, was hospitalized, or had flu-related insurance claims." We did not receive claims data, so this outcomes includes only ER visits and hospitalizations. | Posted | Count of Participants | Participants | 11 months (between September 9, 2021 and July 31, 2022) |
|
|
|
| Other Pre-specified | Flu Vaccination at 2 Weeks After Final Outreach Date by Gender | Received a flu vaccination | Patients were excluded from analyses if they died before or during the study, if they were contraindicated for flu vaccine, if they were sent protective risk reasons, or if they were vaccinated prior to the study beginning. See the Statistical Analysis Plan for more information on exclusions. | Posted | Count of Participants | Participants | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
|
|
|
| Other Pre-specified | Flu Vaccination at 2 Weeks After Final Outreach Date by Race | Received Flu Vaccination | Patients were excluded from analyses if they died before or during the study, if they were contraindicated for flu vaccine, if they were sent protective risk reasons, or if they were vaccinated prior to the study beginning. See the Statistical Analysis Plan for more information on exclusions. | Posted | Count of Participants | Participants | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
|
|
|
| Other Pre-specified | Flu Vaccination at 2 Weeks After Final Outreach Date by Ethnicity | Received flu vaccination | Patients were excluded from analyses if they died before or during the study, if they were contraindicated for flu vaccine, if they were sent protective risk reasons, or if they were vaccinated prior to the study beginning. See the Statistical Analysis Plan for more information on exclusions. | Posted | Count of Participants | Participants | Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start |
|
|
|
| 25 |
| 9,017 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Reminder Control | Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message | 22 | 9,013 | 0 | 0 | 0 | 0 |
| EG002 | High Risk Only | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message | 24 | 9,011 | 0 | 0 | 0 | 0 |
| EG003 | High Risk With Explanation Based on Medical Records | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message | 19 | 9,003 | 0 | 0 | 0 | 0 |
| EG004 | High Risk With Explanation Based on Algorithm | Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message Algorithm-based recommendation: Mailed letter, SMS, and/or patient portal message | 17 | 9,017 | 0 | 0 | 0 | 0 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| Vaccinated |
|
| Flu diagnosis |
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| Flu complications |
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| Utilization |
|
|
| Male |
|
|
|
| Asian |
|
|
| Black |
|
|
| Native Hawaiian or Other Pacific Islander |
|
|
| Unknown |
|
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| White |
|
|
|
| Not Hispanic or Latino |
|
|
| Unable to Obtain |
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|