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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05009251
Other study ID # 2021-0483
Secondary ID P30AG034532
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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