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Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications

Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05509283
Enrollment
40671
Registered
2022-08-22
Start date
2022-09-13
Completion date
2022-10-26
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Health Promotion, Influenza, Risk Reduction, Vaccination

Keywords

Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility

Brief summary

This study will test the relative efficacy of high-risk messages in increasing flu shot rates in patients at moderately high risk for flu and complications (those in the top 11-20% of risk). It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving a flu vaccine.

Detailed description

Almost everyone age 6 months or older can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death by reducing the likelihood of contracting influenza. Flu shots are particularly important for patients at high risk of experiencing severe outcomes. In the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that disclosed patients' risk status significantly increased flu vaccination rates. Additionally, messages that included risk information were most effective in patients at relatively lower risk (those in the top 4-10%) compared with those at the highest risk (top 3%). The present work will test the effectiveness of high-risk messages in patients who are in the top 11-20% of risk, at high risk but lower than previous studies. These communications will inform patients they are at high risk with either (a) no additional explanation, (b) an explanation that this determination comes from an analysis of their medical records, or (c) the additional explanation that an AI or ML algorithm made this determination.

Interventions

BEHAVIORALRisk Reduction

Letter, patient portal, SMS and/or another modality

Sponsors

National Bureau of Economic Research, Inc.
CollaboratorOTHER
Massachusetts Institute of Technology
CollaboratorOTHER
Geisinger Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

Providers who prescribe vaccination and diagnose conditions will not be randomized to study arms or informed of patient assignment. Although patients will not be explicitly informed which arm they have been randomized to, they will be aware of the messages they receive.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record \[EHR\] since at least September 2021 and had at least one encounter in 2020-2022) * Aged 18 or older * In the top 11-20% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data) * Has a Geisinger PCP assigned as of August 2022 * Has had an encounter in the last 2 years as of August 2022

Exclusion criteria

\- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities

Design outcomes

Primary

MeasureTime frameDescription
Flu vaccinationWithin 6 weeks of the patient's study start dateReceived a flu vaccination within within 6 weeks of the patient's study start date

Other

MeasureTime frameDescription
Likely flu diagnosisUp to 8 monthsReceived a high confidence flu diagnosis (with positive 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 study start date through April 30, 2023). Note that likely flu is a superset of the high confidence flu diagnoses.
Flu complicationsUp to 11 monthsDiagnosed with flu-related complications (yes/no) from the patient's study start date through July 31, 2023.
High confidence flu diagnosisUp to 8 monthsPatient 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 study start date through April 30, 2023).
HospitalizationsUp to 11 monthsNumber of hospitalizations from the patient's study start date through July 31, 2023.
COVID-19 vaccination ratesUp to 8 monthsReceived at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's study start date through April 30, 2023).
ER visitsUp to 11 monthsNumber of ER visits from the patient's study start date through July 31, 2023.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026