An interventional study of Risk reduction and Medical records-based recommendation in Influenza, Vaccination and Health Promotion, sponsored by Geisinger Clinic. Completed at 1 site in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Geisinger Clinic · Not applicable, Interventional, and Prevention
The purpose of the current study is to test different interventions to determine the most effective way to promote flu vaccine uptake in a high-risk population identified by an "artificial intelligence" (AI) or machine learning (ML) algorithm. The specific aims are:
Background
On average, 8% of the US population gets sick from flu each flu season (Tokars et al. 2018). Since 2010, the annual disease burden of influenza has included 9-45 million illnesses, 140,000-810,000 hospitalizations, and 12,000-61,000 deaths (CDC 2020). The CDC recommends the 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 (CDC 2019a). Flu vaccination will be especially important for high-risk patients during the COVID-19 pandemic so that flu cases are reduced and resources conserved.
While most recover from influenza without treatment, the elderly, those with comorbidities, and other high-risk individuals can experience complications such as pneumonia, other respiratory illness, and death. Geisinger, a large health system in Pennsylvania and New Jersey, has partnered with Medial EarlySign (Medial; www.earlysign.com) to develop a machine learning (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 deploy this system during the 2020-21 flu season and contact the identified patients with special messages (in addition to standard efforts made by the health system every flu season) to encourage vaccination. Flu vaccination will be especially important for high-risk patients during the COVID-19 pandemic so that flu cases are reduced and resources conserved.
Published results suggest Medial's ML systems identify high-risk patients in other contexts (Goshen et al., 2018; Zack et al., 2019). However, there is little evidence about (a) whether informing patients they are at high risk makes them more likely to receive vaccination; (b) how patients react to being told their risk status is the result of an analysis of their health records; and (c) whether informing patients their risk status has been determined by an "algorithm," by "machine learning," and/or by "artificial intelligence" will increase or decrease their likelihood of getting vaccinated. This study will address these gaps in the literature, which are especially important in light of the anticipated future growth of AI/ML system use throughout healthcare.
Medial's algorithm is an example of how interoperable health information exchange (HIE)-the ability for health information technology to share patient data-can improve the efficiency and effectiveness of healthcare. However, patients may not appreciate these benefits or the fact that healthcare has become substantially more integrated and collaborative. A systematic review of patient privacy concerns about HIE found that 15-74% of patients expressed privacy concerns, depending on the study, and concluded that patient perspectives remain poorly understood. A flu outreach message that explicitly references a review of patient medical records might backfire as patients react badly to a sense they have lost control of their health records.
There is conflicting evidence on how people respond to advice or information that comes from an algorithm or machine. Dietvorst et al. (2015) documented a pattern of "algorithm aversion," in which people choose inferior human over superior algorithmic forecasts, especially after they observed the algorithm make an error. In contrast, Logg et al. (2018) described "algorithm appreciation," in which people followed advice more when they thought it came from algorithms than when they thought it came from human beings. Finally, Bigman and Gray (2019) found aversion to algorithms that make "moral decisions," including a (fictitious) medical decision of choosing whether or not to operate on a high-risk patient. In the current setting, the algorithm is merely advising patients on taking an action (an annual flu shot) that is already the standard of care, and there is no opportunity to observe an erroneous recommendation, so the hypothesis is that "algorithm appreciation" will cause people to react positively to being informed of the algorithm's role. Thus, this study will address two important research questions:
Our specific aims are:
Research Strategy
Included in the study will be current Geisinger patients 17+ years of age with one or more visits to a Geisinger primary care physician (PCP) between January 1, 2008 and January 30, 2020 and no contraindications for flu vaccine. Medial will provide flu-complication risk scores from their ML algorithm (based on coded EHR data), on the basis of which the top 10% of patients at highest risk will be included. Based on prior behavior and other predictors in a second ML model, Medial will also provide the likelihood each patient will get vaccinated during the study flu season; these values and the primary risk scores will be used as covariates in exploratory data analyses. The anticipated number of patients in the top 10% of risk is 56,000.
On average in the last 3 flu seasons, 55% of Geisinger patients aged 65+ are vaccinated each season, so we will use this as a proxy base rate for a control condition in our power analysis. The study will have 92% power to detect a 2% absolute difference or greater in the vaccination outcome between conditions (55% vs 57%, two-tailed alpha of .05), on the assumption that each condition will have 56,000/4=14,000 patients. For the rarer outcome of flu diagnosis, we have 95% power to detect a 0.8% absolute difference or greater-from an estimated 3.9% rate in this high-risk population (based on the CDC estimate for people age 65+ [Tokars et al., 2018]) to a 3.1% rate.
The primary study outcomes will be the rates of flu vaccination and flu diagnoses during the 2020-21 season (September-March) by targeted patients. Secondary, exploratory outcomes will also be measured: Rates of flu vaccination and diagnoses by fellow household members of targeted patients; rates of flu vaccination and diagnoses by non-targeted patients who were assigned a risk score that fell just below the cutoff of targeted patients ("sub-threshold risk"); rates of flu complications and flu-like symptoms among targeted patients, household members, and those at sub-threshold risk; and rates of other relevant healthcare utilization outcomes such as ER visits and hospitalizations.
Generalized linear mixed models (GLMMs) will examine the primary study outcomes as a function of the study arms (between-subjects), with patient-visited PCPs and/or clinics included as random effects variables, assuming high intraclass correlation coefficients. GLMMs will specify a binary distribution and log-link function in the case of dichotomous outcome variables (e.g., flu vaccination, flu diagnosis), and a negative binomial distribution and log-link function in the case of any highly positively skewed count variables such as ER visits and hospitalizations (where over-dispersion typically remains in the case of a Poisson distribution model). For these exploratory analyses, within-patient change (from the same period one year earlier) will also be analyzed. Also, each patient will receive the same type of communication (a/b/c/d) via up to three modalities-printed letter to their mailing address, SMS to their mobile phone, and/or secure message via Geisinger's patient portal-depending on what information is on file for each patient. The communication channels used for each patient will be covariates in later analyses.
*Note: The study will not necessarily use the terms "AI," "ML," or "algorithm" in the messages to groups b, c, and d; instead, these messages will be designed to be readable and comprehensible by the patient audience while still including the key concepts that differentiate the interventions from one another.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 117,649 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Geisinger Clinic is the lead sponsor of 127 studies on the registry; 19 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
This group receives 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 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.
This group receives 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.
Behavioral: Risk reduction
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records.
Behavioral: Risk reduction · Behavioral: Medical records-based recommendation
This group receives messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by an AI/ML system.
Behavioral: Risk reduction · Behavioral: Medical records-based recommendation · Behavioral: Algorithm-based recommendation
Patients in this group is in the top 11-20% of risk for flu and complications, slightly lower risk than those included in the intervention, who are in the top 10% of risk for flu and complications. This group of patients does not receive an intervention, but are monitored for flu shots as a comparison to target patients.
This group of patients share an address with target high-risk patients (in arms 1-4). This group does not receive an intervention but is monitored for spillover effects of the intervention.
Mailed letter, SMS, and/or patient portal message
Mailed letter, SMS, and/or patient portal message
Also known as: Credibility
Mailed letter, SMS, and/or patient portal message
Also known as: Credibility
Flu Vaccination Rate
Patient received a flu vaccination
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
Flu Vaccination Rate by Risk Level
Patient received a flu vaccination Note: For patients who received risk communications, those in the top 3% were always told they were in the top 3% of risk. Those in the top 4-10% of risk were randomized to be told that they were in the top 10% of risk or high risk. Control patients in the top 3% and top 4-10% of risk were allocated to the top 3% and randomized to either top 10% or high risk groups, respectively, at the same time as those in the patient contact groups, even though these control patients were not contacted.
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
High Confidence Flu Diagnosis Rate
Patient received a flu diagnosis via a positive PCR/antigen/molecular test
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
"Likely Flu" Diagnosis Rate
Patient received a diagnosis that was likely flu, as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test. Note that this outcome is a superset of the "high confidence flu diagnosis rate" outcome.
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
Flu Complications Rate
Patient was diagnosed with flu-related complications
Time frame: Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration
Change in ER Visits From Pre- to Post-intervention
Number of patient visits to the ER, examining relative rate of visits across Time 1 and 2
Time frame: Within 12 months pre-intervention (Time 1) and within 12 months post-intervention (Time 2)
Change in Hospitalizations From Pre- to Post-intervention
Number of patient hospital visits, examining relative rate of visits across Time 1 and 2
Time frame: Within 12 months pre-intervention (Time 1) and within 12 months post-intervention (Time 2)
Flu Vaccination Among Fellow Household Members
Non-targeted fellow household members of targeted patients received a flu vaccination
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
High Confidence Flu Diagnosis Among Fellow Household Members
Non-targeted fellow household members of targeted patients received a flu diagnosis (via a positive PCR/antigen/molecular test)
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
"Likely Flu" Diagnosis Among Fellow Household Members
Non-targeted fellow household members of targeted patients received a diagnosis that was likely flu (as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test)
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
Flu Complications Among Fellow Household Members
Non-targeted fellow household members of targeted patients were diagnosed with flu-related complications
Time frame: Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration
Flu Vaccination Among Those at Sub-threshold Risk
Non-targeted sub-threshold risk patients received a flu vaccination
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
High Confidence Flu Diagnosis Among Those at Sub-threshold Risk
Non-targeted sub-threshold risk patients received a flu diagnosis (via a positive PCR/antigen/molecular test)
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
"Likely Flu" Diagnosis Among Those at Sub-threshold Risk
Non-targeted sub-threshold risk patients received a diagnosis that was likely flu (as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test)
Time frame: Through the the end of the flu season (May 31st 2021), approximately 9 months assessment duration
Flu Complications Among Those at Sub-threshold Risk
Non-targeted sub-threshold risk patients were diagnosed with flu-related complications
Time frame: Through 3 months after the end of the flu season (August 31st 2021), approximately 12 months assessment duration
| Milestone | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members |
|---|---|---|---|---|---|---|
| Started | 11667 | 11639 | 11652 | 11644 | 46898 | 24149 |
| Completed | 11667 | 11639 | 11652 | 11644 | 46898 | 24149 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Patient received a flu vaccination
| Participants | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm |
|---|---|---|---|---|
| Flu Vaccination Rate | 4901 | 5042 | 5087 | 5090 |
Patient received a flu vaccination Note: For patients who received risk communications, those in the top 3% were always told they were in the top 3% of risk. Those in the top 4-10% of risk were randomized to be told that they were in the top 10% of risk or high risk. Control patients in the top 3% and top 4-10% of risk were allocated to the top 3% and randomized to either top 10% or high risk groups, respectively, at the same time as those in the patient contact groups, even though these control patients were not contacted.
| Participants | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm |
|---|---|---|---|---|
| Top 3% | 1485 | 1536 | 1513 | 1537 |
| Top 10% | 1658 | 1749 | 1795 | 1799 |
| High risk | 1758 | 1757 | 1779 | 1754 |
Patient received a flu diagnosis via a positive PCR/antigen/molecular test
No measurements were reported for this outcome.
Patient received a diagnosis that was likely flu, as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test. Note that this outcome is a superset of the "high confidence flu diagnosis rate" outcome.
No measurements were reported for this outcome.
Patient was diagnosed with flu-related complications
No measurements were reported for this outcome.
Number of patient visits to the ER, examining relative rate of visits across Time 1 and 2
No measurements were reported for this outcome.
Number of patient hospital visits, examining relative rate of visits across Time 1 and 2
No measurements were reported for this outcome.
Non-targeted fellow household members of targeted patients received a flu vaccination
| Participants | Control - Household Members | High Risk Only - Household Members | High Risk Based on Medical Records - Household Members | High Risk Based on Algorithm - Household Members |
|---|---|---|---|---|
| Flu Vaccination Among Fellow Household Members | 2136 | 2207 | 2165 | 2175 |
Non-targeted fellow household members of targeted patients received a flu diagnosis (via a positive PCR/antigen/molecular test)
No measurements were reported for this outcome.
Non-targeted fellow household members of targeted patients received a diagnosis that was likely flu (as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test)
No measurements were reported for this outcome.
Non-targeted fellow household members of targeted patients were diagnosed with flu-related complications
No measurements were reported for this outcome.
Non-targeted sub-threshold risk patients received a flu vaccination
| Participants | Sub-threshold Patients |
|---|---|
| Flu Vaccination Among Those at Sub-threshold Risk | 18268 |
Non-targeted sub-threshold risk patients received a flu diagnosis (via a positive PCR/antigen/molecular test)
No measurements were reported for this outcome.
Non-targeted sub-threshold risk patients received a diagnosis that was likely flu (as assessed via ICD codes or Tamiflu administration or positive PCR/antigen/molecular test)
No measurements were reported for this outcome.
Non-targeted sub-threshold risk patients were diagnosed with flu-related complications
No measurements were reported for this outcome.
Patient received a flu vaccination
| Participants | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm |
|---|---|---|---|---|
| American Indian or Alaska Native | 6 | 9 | 6 | 7 |
| Asian | 19 | 14 | 15 | 13 |
| Black or African American | 115 | 134 | 143 | 142 |
| Native Hawaiian or Other Pacific Islander | 5 | 9 | 7 | 7 |
| White | 4751 | 4871 | 4916 | 4914 |
| Unknown | 5 | 5 | 0 | 7 |
Patient received a flu vaccination
| Participants | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm |
|---|---|---|---|---|
| Female | 3118 | 3245 | 3235 | 3197 |
| Male | 1783 | 1797 | 1852 | 1893 |
Patient received a flu vaccination
| Participants | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm |
|---|---|---|---|---|
| Hispanic or Latino | 118 | 173 | 136 | 146 |
| Not Hispanic or Latino | 4778 | 4860 | 4943 | 4938 |
| Unable to obtain | 5 | 9 | 8 | 6 |
Collected over Adverse events were not monitored. See description.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| High Risk Only | — | — | — |
| High Risk Based on Medical Records | — | — | — |
| High Risk Based on Algorithm | — | — | — |
This is the number of participants who were randomized to each arm. Some randomized participants were excluded from analysis if they were vaccinated prior to the study start date or if they were contraindicated for flu vaccine.
| Age, Continuous(years) | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members | Total |
|---|---|---|---|---|---|---|---|
| Mean | 58.0 ± 19.3 | 57.9 ± 19.3 | 57.9 ± 19.2 | 57.6 ± 19.4 | 55.7 ± 19.5 | 47.1 ± 20 | 54.8 ± 19.9 |
| Sex: Female, Male(Participants) | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members | Total |
|---|---|---|---|---|---|---|---|
| Female | 7535 | 7514 | 7533 | 7438 | 29226 | 10744 | 69990 |
| Male | 4132 | 4125 | 4119 | 4206 | 17672 | 13405 | 47659 |
| Ethnicity (NIH/OMB)(Participants) | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 402 | 457 | 395 | 413 | 1684 | 1113 | 4464 |
| Not Hispanic or Latino | 11253 | 11159 | 11240 | 11207 | 45120 | 22777 | 112756 |
| Unknown or Not Reported | 12 | 23 | 17 | 24 | 94 | 259 | 429 |
| Race/Ethnicity, Customized(Participants) | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 22 | 21 | 15 | 22 | 47 | 32 | 159 |
| Asian | 32 | 37 | 28 | 31 | 189 | 124 | 441 |
| Native Hawaiian or Other Pacific Islander | 18 | 26 | 20 | 26 | 126 | 129 | 345 |
| Black or African American | 362 | 382 | 389 | 416 | 1603 | 1116 | 4268 |
| White | 11223 | 11159 | 11194 | 11136 | 44859 | 22674 | 112245 |
| Unknown or Not Reported | 10 | 14 | 6 | 13 | 74 | 72 | 189 |
| Region of Enrollment(participants) | Control | High Risk Only | High Risk Based on Medical Records | High Risk Based on Algorithm | Sub-threshold Patients | Household Members | Total |
|---|---|---|---|---|---|---|---|
| United States | 11667 | 11639 | 11652 | 11644 | 46898 | 24149 | 44602 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: 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.
Access criteria: The data and code are available in the OSF repository at the url below in the folder ClinicalTrials.gov data/Study 1.
Data sharing details ↗ · osf.io
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