Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Influenza Clinical Trial

Official title:

Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009251
• Other study ID #: 2021-0483
• Secondary ID: P30AG034532
• Status: Completed
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2023
• Source: National Bureau of Economic Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45061
• Est. completion date: July 31, 2022
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Health Promotion
• Influenza
• Influenza, Human
• Risk Reduction
• Vaccination

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Geisinger Clinic	Danville	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
National Bureau of Economic Research, Inc.	Geisinger Clinic, Massachusetts Institute of Technology, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Flu Vaccination at 2 Weeks After Final Outreach Date by Race	Received Flu Vaccination	Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start
Other	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
Primary	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	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
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.	8 months (between September 9, 2021 and April 30, 2022)
Secondary	Flu Complications	Diagnosed with flu-related complications	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.	11 months (between September 9, 2021 and July 31, 2022)