High-risk Influenza Vaccine Alert

NCT05492786 | Completed Results DMC

• 2 other identifiers: 2022-0502P30AG034532
• Study Type: interventional
• Target: 80,452
• Locations: 1 country
• Sites: 1

Brief 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. The investigators hypothesize that the salient alerts will lead to increased flu vaccination compared with a standard flu alert.

Conditions

Influenza

Keywords

Vaccination; Health Promotion; Health Behavior; Reminder Systems; Economics, Behavioral; Risk Assessment

Outcome Measures

Primary Outcomes (1)

• Flu Vaccination

  Patient received a flu vaccine (yes/no)

  At the 1 day visit

Other Outcomes (10)

• High Confidence Flu Diagnosis

  Up to 8 months

• "Likely Flu" Diagnosis

  Up to 8 months

• Flu Complications

  Up to 8 months

Study Arms (3)

Standard Alert

ACTIVE COMPARATOR

Standard flu alert

Behavioral: Alert

High-risk Alert

EXPERIMENTAL

Flu alert that indicates patient is at high risk for flu and its complications

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

Behavioral: Alert; Behavioral: Salient alert features; Behavioral: High-risk Text; Behavioral: Risk factors

Interventions

Alert BEHAVIORAL

Non-interruptive best practice alert in the electronic health record

High-risk Alert; High-risk Alert with Risk Factors; Standard Alert

Salient alert features BEHAVIORAL

Larger alert header and body font size, use of different font colors and boldface

High-risk Alert; High-risk Alert with Risk Factors

High-risk Text BEHAVIORAL

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)

High-risk Alert; High-risk Alert with Risk Factors

Risk factors BEHAVIORAL

Alert body indicates the top 3 factors contributing to the high risk

High-risk Alert with Risk Factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Any Geisinger clinician who sees patient-participants in our study for an appointment where their flu shot alert fires

Sponsors & Collaborators

• Geisinger Clinic: lead
• Massachusetts Institute of Technology: collaborator
• National Institute on Aging (NIA): collaborator
• National Bureau of Economic Research, Inc.: collaborator

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Influenza, Human; Health Behavior; Behavior

Interventions

Caffeine; Risk Factors

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Results Point of Contact

• Title: Gail Rosenbaum
• Organization: Geisinger health

grosenbaum@geisinger.edu

570-243-1199

Study Officials

• Christopher F Chabris, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient-participants will not be explicitly told about the different arms, although clinician-participants will see the different arms and may notice these differences.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 30, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
• Access Criteria: The data on the Open Science Framework will be open to anyone requesting that information.

Locations

US (1)