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NCT Number: NCT07798882

Rule-Based High-Risk Flu

Previous work by the study team has shown that informing patients of their high risk of flu and flu-related complications increases their likelihood of getting a flu shot (Rosenbaum et al., 2026). In this work, an artificial intelligence (AI)-based algorithm determined which patients were at high risk for flu. This year, the team will test whether risk messages remain effective when a non-algorithmic rule-based additive risk index (McGovern et al., 2024) is used to identify patients at high risk.

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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 Health

Danville, Pennsylvania, 17822, United States

About this study

While most individuals recover from influenza without complications, certain populations-including older adults and those with underlying medical conditions-are at increased risk for severe outcomes such as pneumonia, other respiratory complications, and death. Identifying these high-risk patients is therefore important for targeting outreach and improving vaccination uptake.

Over the past three influenza seasons, Geisinger has sent as standard of care messages to patients identified as high risk for flu and flu-related complications, informing them of their risk and encouraging vaccination. These messages were implemented following a series of four randomized controlled trials conducted by the study team, which demonstrated that such messages increased influenza vaccination rates (Rosenbaum et al., 2026).

Previously, high-risk patients were identified using an AI-based model. Patients were considered high risk if they were in the top 15% of risk among Geisinger patients eligible for scoring by the model. Due to logistical and resource constraints, this model is no longer available for use. As a result, an alternative, scalable approach is needed to identify high-risk patients for upcoming influenza seasons.

Recent evidence suggests that a simple count of Center for Disease Control (CDC)-defined influenza risk factors is predictive of severe influenza outcomes (McGovern et al., 2024). This approach constructs a rule-based additive risk index by summing the number of CDC-defined high-risk conditions present in each patient's electronic health record. Results indicate that this simple index is highly informative for identifying patients at increased risk of influenza-related complications.

This study will evaluate whether a rule-based additive risk index derived from Electronic Health Record (EHR) data can be used to identify patients at high risk for influenza and influenza-related complications and support targeted outreach. Specifically, the study will assess whether informing patients with four or more CDC risk factors (representing approximately the top 15% of the distribution of scores for eligible patients) of their elevated risk increases influenza vaccination uptake.

Of the 51218 patients who met inclusion criteria, 8750 (17.1%) were randomized to the control group to allow for 80% power to detect a 1.4 percentage-point difference in vaccination rate between control and high-risk outreach groups, with a baseline of 23% and 2-tailed p<.05.

Outreach in the high-risk outreach group will be completed by the Marketing team, using filters for each study modality (mailed letter, patient portal message, text message) including filters for patient contact preferences for patients in the outreach group. In addition to a letter if eligible, patients will be sent either a portal message or a text message (not both) based on their preferences. Marketing cannot apply the same filters to patients in the control group, so to keep analyses unbiased, the primary analyses will be intent-to-treat.

If possible, the study team will attempt to rebuild the filters applied by the Marketing team, and apply them consistently to both high-risk outreach and control groups for a focused exploratory analysis among patients eligible for the messages.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Has four or more CDC risk factors for influenza reflected in EHR data
  • Has a primary care physician employed by Geisinger
  • Attended at least one appointment at Geisinger between 7/17/2024 and 7/16/2026
  • Attended at least one primary care appointment at Geisinger between 10/1/2008 and 7/16/2026

Exclusion criterion:

  • Attended an appointment at Community Care between 9/1/2024 and 7/16/2026

Treatment and study plan

Risk reduction

Behavioral

Mailed letter, patient portal message and/or text message

Primary outcomes

  1. Flu vaccination (y/n)

    Time frame: In the 29 days following the date the first messages were sent

    Flu vaccine documented in the electronic health record

Study contacts

Contact information is provided by the study sponsor or research team.

Gail Rosenbaum, PhD

CONTACT

[email protected]

570-243-1199

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Encouraging Flu Vaccination Among High-Risk Patients Identified by a Rule-Based Additive Risk Index

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

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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