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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509283
• Other study ID #: 2022-0410
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: October 26, 2022

Study information

• Verified date: December 2022
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40671
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Risk Reduction
Letter, patient portal, SMS and/or another modality

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Geisinger Clinic	Massachusetts Institute of Technology, National Bureau of Economic Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High confidence flu diagnosis	Patient 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).	Up to 8 months
Other	"Likely flu" diagnosis	Received 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.	Up to 8 months
Other	Flu complications	Diagnosed with flu-related complications (yes/no) from the patient's study start date through July 31, 2023.	Up to 11 months
Other	ER visits	Number of ER visits from the patient's study start date through July 31, 2023.	Up to 11 months
Other	Hospitalizations	Number of hospitalizations from the patient's study start date through July 31, 2023.	Up to 11 months
Other	COVID-19 vaccination rates	Received 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).	Up to 8 months
Primary	Flu vaccination	Received a flu vaccination within within 6 weeks of the patient's study start date	Within 6 weeks of the patient's study start date