ClinicalTrials.gg
CompletedNCT07798882Updated Oct 16, 2026

Rule-Based High-Risk Flu

An interventional study of Risk reduction in Influenza, Vaccination and Risk Reduction, sponsored by Geisinger Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Prevention

Updated Oct 16, 2026Now CompletedStudy documents posted+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
51,218
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Influenza
  • Vaccination
  • Risk Reduction
  • Health Behavior
  • Health Promotion

Keywords

  • Flu vaccine
  • Choice architecture
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's enrollment of 51,218 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Geisinger Clinic is the lead sponsor of 127 studies on the registry; 17 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 criteria

Exclusion criterion:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51,218 participants (actual)

Study arms

  • No intervention
    Control

    This group will not be sent high-risk flu shot messages, but will be sent normal system messages about flu shots.

  • Experimental
    High-risk outreach

    This group will be sent messages informing them of their high risk for flu and flu-related complications, in addition to the normal system messages sent to the control group.

    Behavioral: Risk reduction

Interventions

  • BehavioralRisk reduction

    Mailed letter, patient portal message and/or text message

06

What researchers measure

Primary outcomes

  1. Flu vaccination (y/n)

    Flu vaccine documented in the electronic health record

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

07

Study locations

1 site
  • Geisinger Health
    Danville, Pennsylvania 17822, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 16, 2026
Enrollment
51215 (estimated)→51218 (actual)
Oct 16, 2026
Documents
Show all 1 update
  1. Oct 16, 2026
    Not yet recruiting→Completed
    Enrollment 51215 (estimated)→51218 (actual)
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07798882
Lead sponsor
Geisinger Clinic
Responsible party
Gail Rosenbaum (Program Director, Behavioral Insights Team, Geisinger Clinic) — Principal investigator
First posted
Sep 2, 2026
Start date
Sep 1, 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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