High-risk Influenza Vaccine Alert

Alerts With Risk Information to Increase Influenza Vaccinations

The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of salient alerts in the electronic health record that indicate a patient's high risk for flu and its complications. The investigators hypothesize that the salient alerts will lead to increased flu vaccination compared with a standard flu alert.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Behavioral: Alert; Behavioral: Salient alert features; Behavioral: High-risk Text; Behavioral: Risk factors

Detailed Description

The CDC (Centers for Disease Control) recommends a 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. One barrier to vaccination is a lack of "cues to action," and, in particular, the lack of direct recommendation from medical personnel; this barrier is arguably the most effectively overcome by a simple nudge of clinicians, compared with barriers such as negative attitudes toward vaccination, low perceived utility of vaccination, and less experience with having received the vaccine.

Geisinger partnered with Medial EarlySign (Medial) to develop a machine learning (ML) algorithm to help identify people at risk for serious flu-associated complications based on existing electronic health record data. Eligible at-risk patients will be randomized to an active control group (clinician will be shown a standard flu alert) or one of two experimental groups (clinician will be shown an alert indicating patient's high risk, with or without describing the patient's factors contributing to that risk).

• Study Type: Interventional
• Enrollment (Actual): 80452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• Age 18+
• Have been determined to be in the top 20% of risk through Medial's ML algorithm
• Attend an appointment where the flu alert fires (Geisinger sets when flu alerts start and end--between ~9/1/2022 and ~4/30/2023, as well as the trigger conditions for the alert, which includes valid departments and visits and excludes contraindications like Guillain-Barre syndrome)

Clinician Inclusion Criteria:

• Any Geisinger clinician who sees patient-participants in our study for an appointment where their flu shot alert fires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Alert; Standard flu alert	Behavioral: Alert; Non-interruptive best practice alert in the electronic health record
Experimental: High-risk Alert; Flu alert that indicates patient is at high risk for flu and its complications	Behavioral: Alert; Non-interruptive best practice alert in the electronic health record; Behavioral: Salient alert features; Larger alert header and body font size, use of different font colors and boldface; Behavioral: High-risk Text; Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk)
Experimental: High-risk Alert with Risk Factors; Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk	Behavioral: Alert; Non-interruptive best practice alert in the electronic health record; Behavioral: Salient alert features; Larger alert header and body font size, use of different font colors and boldface; Behavioral: High-risk Text; Alert header indicates patient is at high risk for flu and its complications; alert body indicates the percentage of risk (e.g., in the top 3% of risk); Behavioral: Risk factors; Alert body indicates the top 3 factors contributing to the high risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flu vaccination	Patient received a flu vaccine (yes/no)	At the 1 day visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ER visits	Number of ER visits from the patient's message appointment date through July 31, 2023	Up to 11 months
Hospitalizations	Number of hospitalizations from the patient's message appointment date through July 31, 2023	Up to 11 months
COVID-19 vaccination rates	Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months
High confidence flu diagnosis	Patient received a flu diagnosis via a positive polymerase chain reaction [PCR]/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months
"Likely 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) (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023) Note that "likely flu" is a superset of the "high confidence flu" diagnoses.	Up to 8 months
Flu complications	Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months
Flu vaccination during the 2022-2023 season	Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: National Institute on Aging (NIA); Massachusetts Institute of Technology; National Bureau of Economic Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Health Promotion; Vaccination; Risk Assessment; Health Behavior; Economics, Behavioral; Reminder Systems
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 2022-0502; P30AG034532 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No