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High-risk Influenza Vaccine Alert

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alert
Salient alert features
High-risk Text
Risk factors
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral, Risk Assessment

Eligibility Criteria

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

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

Sites / Locations

  • Geisinger Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Alert

High-risk Alert

High-risk Alert with Risk Factors

Arm Description

Standard flu alert

Flu alert that indicates patient is at high risk for flu and its complications

Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk

Outcomes

Primary Outcome Measures

Flu vaccination
Patient received a flu vaccine (yes/no)

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
April 24, 2023
Sponsor
Geisinger Clinic
Collaborators
Massachusetts Institute of Technology, National Institute on Aging (NIA), National Bureau of Economic Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05492786
Brief Title
High-risk Influenza Vaccine Alert
Official Title
Alerts With Risk Information to Increase Influenza Vaccinations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

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

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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral, Risk Assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patient-participants will not be explicitly told about the different arms, although clinician-participants will see the different arms and may notice these differences.
Allocation
Randomized
Enrollment
80452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Alert
Arm Type
Active Comparator
Arm Description
Standard flu alert
Arm Title
High-risk Alert
Arm Type
Experimental
Arm Description
Flu alert that indicates patient is at high risk for flu and its complications
Arm Title
High-risk Alert with Risk Factors
Arm Type
Experimental
Arm Description
Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk
Intervention Type
Behavioral
Intervention Name(s)
Alert
Intervention Description
Non-interruptive best practice alert in the electronic health record
Intervention Type
Behavioral
Intervention Name(s)
Salient alert features
Intervention Description
Larger alert header and body font size, use of different font colors and boldface
Intervention Type
Behavioral
Intervention Name(s)
High-risk Text
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Risk factors
Intervention Description
Alert body indicates the top 3 factors contributing to the high risk
Primary Outcome Measure Information:
Title
Flu vaccination
Description
Patient received a flu vaccine (yes/no)
Time Frame
At the 1 day visit
Other Pre-specified Outcome Measures:
Title
High confidence flu diagnosis
Description
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)
Time Frame
Up to 8 months
Title
"Likely 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) (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.
Time Frame
Up to 8 months
Title
Flu complications
Description
Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Time Frame
Up to 8 months
Title
ER visits
Description
Number of ER visits from the patient's message appointment date through July 31, 2023
Time Frame
Up to 11 months
Title
Hospitalizations
Description
Number of hospitalizations from the patient's message appointment date through July 31, 2023
Time Frame
Up to 11 months
Title
COVID-19 vaccination rates
Description
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)
Time Frame
Up to 8 months
Title
Flu vaccination during the 2022-2023 season
Description
Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
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.

Learn more about this trial

High-risk Influenza Vaccine Alert

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