High-risk Influenza Vaccine Alert

Influenza Clinical Trial

Official title:

Alerts With Risk Information to Increase Influenza Vaccinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492786
• Other study ID #: 2022-0502
• Secondary ID: P30AG034532
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2024
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80452
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Behavioral:
• Alert
Non-interruptive best practice alert in the electronic health record
• Salient alert features
Larger alert header and body font size, use of different font colors and boldface
• 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)
• Risk factors
Alert body indicates the top 3 factors contributing to the high risk

Locations

Country	Name	City	State
United States	Geisinger Clinic	Danville	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Geisinger Clinic	Massachusetts Institute of Technology, National Bureau of Economic Research, Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	"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
Other	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
Other	ER Visits	Number of ER visits from the patient's message appointment date through July 31, 2023	Up to 11 months
Other	Hospitalizations	Number of hospitalizations from the patient's message appointment date through July 31, 2023	Up to 11 months
Other	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
Other	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
Other	Flu Vaccination by Sex	Patient received a flu vaccine (yes/no)	At the 1 day visit
Other	Flu Vaccination by Race	Patient received a flu vaccine (yes/no)	At the 1 day visit
Other	Flu Vaccination by Ethnicity	Patient received a flu vaccine (yes/no)	At the 1 day visit
Primary	Flu Vaccination	Patient received a flu vaccine (yes/no)	At the 1 day visit