Efficacy of Communication Modalities for Promoting Flu Shots

Health Behavior Clinical Trial

Official title:

Assessing the Relative Efficacy of Communication Modalities for Messages Promoting Flu Shots

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509270
• Other study ID #: 2022-0373
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: October 4, 2022

Study information

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

Clinical Trial Summary

The purpose of this study is to test which modalities (mailed letter, short message service [SMS] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients.

Description:

The Centers for Disease Control (CDC) 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. Flu shots are particularly important for patients at high risk of experiencing severe outcomes. During 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 told patients they were at high risk significantly increased their likelihood of getting vaccinated. The present study will extend previous work by testing which modality or modalities are most effective at boosting flu shot rates in patients at high risk. In previous campaigns, patients received messages via all communication modalities patients were eligible for (mailed letter, SMS text, and/or patient portal message). In this study, patients will be randomized to receive high-risk messages in one or more modalities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43225
• Est. completion date: October 4, 2022
• Est. primary completion date: October 4, 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 10% 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 Vaccination
• Risk Reduction

Intervention

Behavioral:
• Letter
Mailed letter about flu vaccination
• Patient portal
Patient portal message about flu vaccination
• SMS
SMS about flu vaccination

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

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 first message send 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 first message send 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 first message send date through July 31, 2023.	Up to 11 months
Other	ER visits	Number of ER visits from the first message send date through July 31, 2023.	Up to 11 months
Other	Hospitalizations	Number of hospitalizations from the first message send 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 first message send date through April 30, 2023).	Up to 8 months
Primary	Flu vaccination	Flu vaccination within 4 weeks of the first message send date	4 weeks after the first messages are sent in the study