High-risk Influenza Vaccine Alert

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05492786

Collaborator

(none)

60,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Behavioral: Alert Behavioral: Salient alert features Behavioral: High-risk Text Behavioral: Risk factors	N/A

Detailed Description

The CDC 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.

Eligible 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 Design

Study Type:

Interventional

Anticipated Enrollment :

60000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Prevention

Official Title:

Alerts With Risk Information to Increase Influenza Vaccinations

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Flu vaccination [At the 1 day visit]
Patient receives a flu vaccine (yes/no)

Other Outcome Measures

High confidence flu diagnosis [Up to 8 months]
Patient received a flu diagnosis via a positive PCR/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023).
"Likely flu" diagnosis [Up to 8 months]
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.
Flu complications [Up to 8 months]
Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023).
ER visits [Up to 11 months]
Number of ER visits from the patient's message appointment date through July 31, 2023
Hospitalizations [Up to 11 months]
Number of hospitalizations from the patient's message appointment date through July 31, 2023
COVID-19 vaccination rates [Up to 8 months]
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).
Flu vaccination during the 2022-2023 season [Up to 8 months]
Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patient Inclusion Criteria:

Age 18+
On a list of active Geisinger patients (patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the electronic health record since at least September 2021 and had at least one encounter in 2020-2022)
Has been determined to be high risk via a machine learning algorithm among eligible patients (about 20% of patients are expected to be at significantly elevated risk)
Attend an appointment where the flu alert fires (Geisinger sets when flu alerts start and ends--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)