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Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Primary Purpose

Influenza, Vaccination, Health Promotion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reminder
Risk reduction
Medical records-based recommendation
Algorithm-based recommendation
Sponsored by
National Bureau of Economic Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility, Personalized Risk Factors, Flu Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

No-Contact Control

Reminder Control

High Risk Only

High Risk with Explanation Based on Medical Records

High Risk with Explanation Based on Algorithm

Arm Description

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.

Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status.

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.

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.

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.

Outcomes

Primary Outcome Measures

Flu Vaccination at 2 Weeks After Final Outreach Date
Received flu vaccination

Secondary Outcome Measures

Flu Vaccination at 9 Weeks After Final Outreach Date
Received a flu vaccination
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.
Flu Complications
Diagnosed with flu-related complications
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.

Full Information

First Posted
August 4, 2021
Last Updated
July 20, 2023
Sponsor
National Bureau of Economic Research, Inc.
Collaborators
Geisinger Clinic, Massachusetts Institute of Technology, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05009251
Brief Title
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
Official Title
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Bureau of Economic Research, Inc.
Collaborators
Geisinger Clinic, Massachusetts Institute of Technology, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Vaccination, Health Promotion, Health Behavior, Risk Reduction
Keywords
Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility, Personalized Risk Factors, Flu Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
45061 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No-Contact Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Reminder Control
Arm Type
Experimental
Arm Description
Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status.
Arm Title
High Risk Only
Arm Type
Experimental
Arm Description
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.
Arm Title
High Risk with Explanation Based on Medical Records
Arm Type
Experimental
Arm Description
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.
Arm Title
High Risk with Explanation Based on Algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reminder
Intervention Description
Mailed letter, short message service (SMS) text, and/or patient portal message
Intervention Type
Behavioral
Intervention Name(s)
Risk reduction
Intervention Description
Mailed letter, SMS, and/or patient portal message
Intervention Type
Behavioral
Intervention Name(s)
Medical records-based recommendation
Other Intervention Name(s)
Credibility
Intervention Description
Mailed letter, SMS, and/or patient portal message
Intervention Type
Behavioral
Intervention Name(s)
Algorithm-based recommendation
Other Intervention Name(s)
Credibility
Intervention Description
Mailed letter, SMS, and/or patient portal message
Primary Outcome Measure Information:
Title
Flu Vaccination at 2 Weeks After Final Outreach Date
Description
Received flu vaccination
Time Frame
Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start
Secondary Outcome Measure Information:
Title
Flu Vaccination at 9 Weeks After Final Outreach Date
Description
Received a flu vaccination
Time Frame
Within 9 weeks of the final outreach date, 106 days (15.14 weeks) after the study start
Title
Flu Diagnosis
Description
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.
Time Frame
8 months (between September 9, 2021 and April 30, 2022)
Title
Flu Complications
Description
Diagnosed with flu-related complications
Time Frame
11 months (between September 9, 2021 and July 31, 2022)
Title
Healthcare Utilization
Description
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.
Time Frame
11 months (between September 9, 2021 and July 31, 2022)
Other Pre-specified Outcome Measures:
Title
Flu Vaccination at 2 Weeks After Final Outreach Date by Gender
Description
Received a flu vaccination
Time Frame
Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start
Title
Flu Vaccination at 2 Weeks After Final Outreach Date by Race
Description
Received Flu Vaccination
Time Frame
Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start
Title
Flu Vaccination at 2 Weeks After Final Outreach Date by Ethnicity
Description
Received flu vaccination
Time Frame
Within 2 weeks of the final outreach date, 57 days (8.14 weeks) after the study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle N Meyer, PhD JD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher F Chabris, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
IPD Sharing Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
IPD Sharing URL
http://osf.io

Learn more about this trial

Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

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