InfluenzaNCT07798882
Rule-Based High-Risk Flu
A study testing Risk reduction in people with Influenza and Vaccination, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Vaccination, Risk Reduction
- What is being tested?
- Risk reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51,218 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Attended an appointment at Community Care between 9/1/2024 and 7/16/2026
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Encouraging Flu Vaccination Among High-Risk Patients Identified by a Rule-Based Additive Risk Index
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.
- Conditions
- Influenza, Vaccination, Risk Reduction, Health Behavior, Health Promotion
- Being tested
- Risk reduction
- Keywords
- Flu vaccine, Choice architecture
- Medical subject headings
- Influenza, Human, Risk Reduction Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk reductionBehavioural
Mailed letter, patient portal message and/or text message
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will not be sent high-risk flu shot messages, but will be sent normal system messages about flu shots. |
| High-risk outreach | Experimental | 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. Receives: Behavioral: Risk reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu vaccination (y/n)
Flu vaccine documented in the electronic health record
Measured: In the 29 days following the date the first messages were sent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients from the high-risk sample will be randomly assigned to one of 2 groups: * Control: Not sent high-risk flu messages. * High-risk outreach: Sent high-risk flu messages if they meet criteria set by the Marketing message campaign. Both groups will be sent additional system messages about flu shots that do not mention high-risk status.
- Masking
- None (open label)
- Enrolment
- 51,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Rosenbaum, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798882
- Sponsor's protocol ID
- 2026-0673
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Flu Vaccination Among High-Risk Patients Identified by a Rule-Based Additive Risk Index
- ClinicalTrials.gov ID
- NCT07798882
- Acronym / sponsor ID
- 2026-0673
- Conditions
- Influenza, Vaccination, Risk Reduction, Health Behavior, Health Promotion
- Keywords
- Flu vaccine, Choice architecture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51,218 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients from the high-risk sample will be randomly assigned to one of 2 groups: * Control: Not sent high-risk flu messages. * High-risk outreach: Sent high-risk flu messages if they meet criteria set by the Marketing message campaign. Both groups will be sent additional system messages about flu shots that do not mention high-risk status.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will not be sent high-risk flu shot messages, but will be sent normal system messages about flu shots. |
| High-risk outreach | Experimental | Behavioral: Risk reductionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Attended an appointment at Community Care between 9/1/2024 and 7/16/2026
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk reductionMailed letter, patient portal message and/or text message | Behavioural | High-risk outreach |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk reduction in people with Influenza and Vaccination, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flu vaccination (y/n) (time frame: In the 29 days following the date the first messages were sent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.