Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Conditions
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Influenza, Vaccination, Health Promotion, Health Behavior, Risk Reduction

Intervention / Treatment
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* Behavioral: Reminder
* Behavioral: Risk reduction
* Behavioral: Medical records-based recommendation
* Behavioral: Algorithm-based recommendation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or older Current Geisinger patient at the time of study Falls in the top 10% of patients at highest risk, as identified by the flu-complication risk scores of machine learning algorithm (which operates on coded EHR data) Exclusion Criteria: Has contraindications for flu vaccination Has opted out of receiving communications from Geisinger via all of the modalities being tested

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients from the high-risk sample will be randomly assigned to one of five arms: No-Contact Control Arm Reminder Control Arm High Risk Only Arm High Risk with Explanation Based on Medical Records Arm High Risk with Explanation Based on Algorithm Arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No-Contact Control<br>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. | |
| Experimental: Reminder Control<br>Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. | Behavioral: Reminder<br>* Mailed letter, short message service (SMS) text, and/or patient portal message<br>|
| Experimental: High Risk Only<br>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. | Behavioral: Reminder<br>* Mailed letter, short message service (SMS) text, and/or patient portal message<br>Behavioral: Risk reduction<br>* Mailed letter, SMS, and/or patient portal message<br>|
| Experimental: High Risk with Explanation Based on Medical Records<br>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. | Behavioral: Reminder<br>* Mailed letter, short message service (SMS) text, and/or patient portal message<br>Behavioral: Risk reduction<br>* Mailed letter, SMS, and/or patient portal message<br>Behavioral: Medical records-based recommendation<br>* Mailed letter, SMS, and/or patient portal message<br>* Other names: Credibility;|
| Experimental: High Risk with Explanation Based on Algorithm<br>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. | Behavioral: Reminder<br>* Mailed letter, short message service (SMS) text, and/or patient portal message<br>Behavioral: Risk reduction<br>* Mailed letter, SMS, and/or patient portal message<br>Behavioral: Medical records-based recommendation<br>* Mailed letter, SMS, and/or patient portal message<br>* Other names: Credibility;Behavioral: Algorithm-based recommendation<br>* Mailed letter, SMS, and/or patient portal message<br>* Other names: Credibility;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility, Personalized Risk Factors, Flu Complications