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OpenTrials
Completed

NCT Number: NCT05492786

High-risk Influenza Vaccine Alert

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alert

Behavioral

Non-interruptive best practice alert in the electronic health record

Salient alert features

Behavioral

Larger alert header and body font size, use of different font colors and boldface

High-risk Text

Behavioral

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

Behavioral

Alert body indicates the top 3 factors contributing to the high risk

Primary outcomes

  1. Flu Vaccination

    Time frame: At the 1 day visit

    Patient received a flu vaccine (yes/no)

Other outcomes

  1. High Confidence Flu Diagnosis

    Time frame: Up to 8 months

    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)

  2. "Likely Flu" Diagnosis

    Time frame: 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.

  3. Flu Complications

    Time frame: 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)

  4. ER Visits

    Time frame: Up to 11 months

    Number of ER visits from the patient's message appointment date through July 31, 2023

  5. Hospitalizations

    Time frame: Up to 11 months

    Number of hospitalizations from the patient's message appointment date through July 31, 2023

  6. COVID-19 Vaccination Rates

    Time frame: 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)

  7. Flu Vaccination During the 2022-2023 Season

    Time frame: 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)

  8. Flu Vaccination by Sex

    Time frame: At the 1 day visit

    Patient received a flu vaccine (yes/no)

  9. Flu Vaccination by Race

    Time frame: At the 1 day visit

    Patient received a flu vaccine (yes/no)

  10. Flu Vaccination by Ethnicity

    Time frame: At the 1 day visit

    Patient received a flu vaccine (yes/no)

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Massachusetts Institute of Technology
  • National Bureau of Economic Research, Inc.
  • National Institute on Aging (NIA)

Registry information

Official study title

Alerts With Risk Information to Increase Influenza Vaccinations

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2022
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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