Nudging Flu Vaccination by Making it Easy for Patients to Schedule a Flu Shot

Influenza Clinical Trial

Official title:

Nudging Flu Vaccination by Making it Easy for Patients to Schedule a Flu Shot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493787
• Other study ID #: 2022-0500
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: January 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination.

Description:

The 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. Past work from the study team focused on encouraging flu shots for patients with upcoming appointments. However, many patients in the health system do not have any appointments during flu season. Eligible patients without an upcoming appointment will be randomized to a passive control group (no message), an active control group (a basic message stating that the patient can get a flu shot at Geisinger) or one of several other messages informed by behavioral science ("ease", "waiting for you", "protect yourself - rare outcomes", or "protect yourself - frequent outcomes"). Patients will be randomly assigned to one of several message send dates. Messages sent via patient portal, short message service (SMS) text, email, and/or another modality, will include a link redirecting patients to a page where they can self-schedule a flu shot.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139503
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Included in one or both of the following two base patient lists:

1. Geisinger patient portal flu outreach list for Fall 2022

2. A list of patients obtained from Geisinger's Phenomics and Clinical Data Core (PACDC). This list will include 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 as of October 2022
• Has had a Geisinger encounter in the last 2 years as of October 2022
• Either of the following, as of October 2022:

1. Has a Geisinger PCP assigned in the Community Medicine, Pediatrics, or Internal Medicine service line

2. In the last 2 years, has completed an appointment in a Geisinger specialty on a list of specialties approved by system leadership for flu shot communications

• Has not received a flu-shot during the 2022-23 flu season as of ~1 week prior to the message date (timeline may be slightly different, depending on data pull logistics), according to the Electronic Health Record (EHR)
• Does not have a scheduled in-person primary care or in-person flu-shot-eligible specialty appointment in the 12 weeks following their assigned message send date, as of ~1 week prior to the message date (timelines may be slightly different, depending on data pull logistics or clinical guidance)
• As of this writing, the team plans to define a flu-shot-eligible specialty appointments as appointments in departments that have historically documented or administered flu vaccine. However, this approach may change slightly based on changing clinical guidance.

Exclusion Criteria:

• The CMSL/Marketing list will include patients in Geisinger's 65Forward or Community Care populations. If necessary due to logistical constraints, we may exclude these 65Forward and/or Community Care patients from our study.
• Cannot be contacted via the communication modality being used in the study (e.g., patient portal, SMS), e.g., due to insufficient/missing contact information in the EHR or because they opted out
• Has an allergy to flu vaccines according to any EHR allergy table known to the study team
• Has a health maintenance modifier indicating they are permanently discontinued from receiving a seasonal flu shot
• Is on a list of dismissed patients

Related Conditions & MeSH terms

• Influenza

Intervention

Behavioral:
• Reminder
Patient portal, SMS, email, and/or another modality

Locations

Country	Name	City	State
United States	Geisinger Clinic	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 PCR/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023).	Up to 7 months
Other	"Likely flu" diagnosis	Received a "high confidence flu" diagnosis (with positive polymerase chain reaction [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 message send date through April 30, 2023).; Note that "likely flu" is a superset of the "high confidence flu" diagnoses.	Up to 7 months
Other	Flu complications	Diagnosed with flu-related complications (yes/no) from the patient's message send date through July 31, 2023.	Up to 10 months
Other	ER visits	Number of ER visits from the patient's message send date through July 31, 2023.	Up to 10 months
Other	Hospitalizations	Number of hospitalizations from the patient's message send date through July 31, 2023.	Up to 10 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 message send date through April 30, 2023).	Up to 7 months
Primary	Flu shot self-scheduling	Patient self-schedules a flu vaccine appointment through the patient portal (yes/no); This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date.	Within 4 weeks of message send date
Secondary	Flu vaccination	Patient receives a flu vaccine (yes/no)	Within 4 weeks of message send date