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| Name | Class |
|---|---|
| National Bureau of Economic Research, Inc. | OTHER |
| Massachusetts Institute of Technology | OTHER |
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This study will test the relative efficacy of high-risk messages in increasing flu shot rates in patients at moderately high risk for flu and complications (those in the top 11-20% of risk). 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 a flu vaccine.
Almost everyone age 6 months or older can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death by reducing the likelihood of contracting influenza. Flu shots are particularly important for patients at high risk of experiencing severe outcomes.
In the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that disclosed patients' risk status significantly increased flu vaccination rates. Additionally, messages that included risk information were most effective in patients at relatively lower risk (those in the top 4-10%) compared with those at the highest risk (top 3%).
The present work will test the effectiveness of high-risk messages in patients who are in the top 11-20% of risk, at high risk but lower than previous studies. 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, or (c) the additional explanation that an AI or ML algorithm made this determination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive control | No Intervention | Patients in the passive 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. | |
| Active control | Experimental | Patients in the active control arm will receive messages reminding them to get a flu shot without being advised of their risk status. |
|
| High risk only | Experimental | Patients 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. |
|
| Risk based on medical records | Experimental | Patients 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. |
|
| High risk based on algorithm | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Reduction | Behavioral | Letter, patient portal, SMS and/or another modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flu vaccination | Received a flu vaccination within within 6 weeks of the patient's study start date | Within 6 weeks of the patient's study start date |
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| Measure | Description | Time Frame |
|---|---|---|
| High confidence flu diagnosis | Patient received a flu diagnosis via a positive polymerase chain reaction (PCR)/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's study start date through April 30, 2023). | Up to 8 months |
| "Likely flu" diagnosis |
Inclusion Criteria:
Exclusion criteria:
- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Chabris, PhD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger | 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.
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
The data on the Open Science Framework will be open to anyone requesting that information.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2022 | Oct 25, 2022 | Prot_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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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.
Patients 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.
|
Received a "high confidence flu" diagnosis (with positive 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 study start date through April 30, 2023). Note that "likely flu" is a superset of the "high confidence flu" diagnoses. |
| Up to 8 months |
| Flu complications | Diagnosed with flu-related complications (yes/no) from the patient's study start date through July 31, 2023. | Up to 11 months |
| ER visits | Number of ER visits from the patient's study start date through July 31, 2023. | Up to 11 months |
| Hospitalizations | Number of hospitalizations from the patient's study start date through July 31, 2023. | Up to 11 months |
| COVID-19 vaccination rates | Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's study start date through April 30, 2023). | Up to 8 months |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |