InfluenzaNCT05492786
High-risk Influenza Vaccine Alert
A study testing Alert, Salient alert features and High-risk Text in people with Influenza, run by Geisinger Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Alert, Salient alert features and High-risk Text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80,452 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alerts With Risk Information to Increase Influenza Vaccinations
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.
Read the detailed 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).
- Conditions
- Influenza
- Being tested
- Alert, Salient alert features, High-risk Text, Risk factors
- Keywords
- Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral, Risk Assessment
- Medical subject headings
- Influenza, Human, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlertBehavioural
Non-interruptive best practice alert in the electronic health record
Salient alert featuresBehavioural
Larger alert header and body font size, use of different font colors and boldface
High-risk TextBehavioural
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 factorsBehavioural
Alert body indicates the top 3 factors contributing to the high risk
| Study group | Role | What they receive |
|---|---|---|
| Standard Alert | Active comparator | Standard flu alert Receives: Behavioral: Alert |
| High-risk Alert | Experimental | Flu alert that indicates patient is at high risk for flu and its complications Receives: Behavioral: Alert; Behavioral: Salient alert features; Behavioral: High-risk Text |
| High-risk Alert with Risk Factors | Experimental | Flu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk Receives: Behavioral: Alert; Behavioral: Salient alert features; Behavioral: High-risk Text; Behavioral: Risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu Vaccination
Patient received a flu vaccine (yes/no)
Measured: At the 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, National Institute on Aging (NIA), National Bureau of Economic Research, Inc.
- Responsible party
- Principal investigator, Christopher F Chabris, PhD, Geisinger Clinic
- Investigators
- Christopher F Chabris, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492786
- Sponsor's protocol ID
- 2022-0502
- Other IDs
- P30AG034532
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2022
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alerts With Risk Information to Increase Influenza Vaccinations
- ClinicalTrials.gov ID
- NCT05492786
- Acronym / sponsor ID
- 2022-0502
- Conditions
- Influenza
- Keywords
- Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral, Risk Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80,452 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, National Institute on Aging (NIA), National Bureau of Economic Research, Inc.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Alert | Active comparator | Behavioral: AlertStandard flu alert |
| High-risk Alert | Experimental | Behavioral: Alert, Behavioral: Salient alert features, Behavioral: High-risk TextFlu alert that indicates patient is at high risk for flu and its complications |
| High-risk Alert with Risk Factors | Experimental | Behavioral: Alert, Behavioral: Salient alert features, Behavioral: High-risk Text, Behavioral: Risk factorsFlu alert that indicates patient is at high risk for flu and its complications and presents the factors contributing to this high risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AlertNon-interruptive best practice alert in the electronic health record | Behavioural | High-risk Alert, High-risk Alert with Risk Factors, Standard Alert |
| Salient alert featuresLarger alert header and body font size, use of different font colors and boldface | Behavioural | High-risk Alert, High-risk Alert with Risk Factors |
| High-risk TextAlert 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) | Behavioural | High-risk Alert, High-risk Alert with Risk Factors |
| Risk factorsAlert body indicates the top 3 factors contributing to the high risk | Behavioural | High-risk Alert with Risk Factors |
Primary outcome
Flu Vaccination
Time frame: At the 1 day visit
Patient received a flu vaccine (yes/no)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
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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.
Christopher F Chabris, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert, Salient alert features and High-risk Text in people with Influenza, 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?
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 30 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: At the 1 day visit). 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 30 Dec 2024.