Flu Shot Pre-visit Questionnaire

Pre-visit Questionnaire to Increase Influenza Vaccinations

The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of a pre-visit questionnaire that asks patients to indicate their preferences for a flu shot. Responses to the questionnaire will also be shown to clinicians via additional text in an existing flu shot alert. The investigators hypothesize that the pre-visit questionnaire will lead to increased flu vaccination compared with standard practices.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Behavioral: Precommitment Nudge; Behavioral: Salience

Detailed Description

The CDC (Centers for Disease Control and Prevention) 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. One barrier to vaccination is a lack of "cues to action," which could be overcome by asking patients for a pre-visit commitment to get a flu shot and additional reminders for the clinician to act on this commitment.

Eligible patients will be randomized to either receive or not receive a one-item, pre-visit questionnaire about the flu shot (that will show responses to clinicians in an existing flu shot alert).

• Study Type: Interventional
• Enrollment (Actual): 230962
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

• 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)
• Has an upcoming flu shot-eligible outpatient visit with a provider
• Has activated Geisinger's patient portal
• Has not yet received a flu vaccine at the time the questionnaire became available, according to the EHR

Clinician Inclusion Criteria

• Any Geisinger clinician who sees patient-participants in our study for a flu shot-eligible outpatient visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Passive Control; No change to the standard of care for flu vaccines
Experimental: Pre-visit Questionnaire; One-item questionnaire in online patient portal and additional information in the flu shot alert	Behavioral: Precommitment Nudge; Ask participants to commit to a decision about getting a flu shot; Behavioral: Salience; Additional text and icon in the flu shot alert makes the pre-visit questionnaire response salient to the clinician, which could facilitate action or further discussion with the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of patients with a flu vaccination	Patient received a flu vaccine (yes/no) between the day questionnaires became available for the patient's first scheduled flu-shot-eligible appointment and 7 days following the appointment. Questionnaires were available 14 days prior to the appointment date for appointments scheduled at least 14 days in advance. Questionnaires were available on the day the appointment was scheduled for appointments scheduled less than 14 days in advance. Note that control patients did not receive a flu shot questionnaire, but they may have received other questionnaires from the health system 14 days before their appointment. We will conduct subgroup analyses for people who had responded to MyGeisinger pre-visit messages in the previous year and those who did not.	Up to 21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of patients with a 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 appointment date through April 30, 2023)	Up to 8 months
Count of patients with a "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 appointment date through April 30, 2023) Note that "likely flu" is a superset of the "high confidence flu" diagnoses	Up to 8 months
Count of patients with flu complications	Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months
ER visits	Number of ER visits from the patient's message appointment date through July 31, 2023	Up to 11 months
Hospitalizations	Number of hospitalizations from the patient's message appointment date through July 31, 2023	Up to 11 months
COVID-19 vaccination rates	Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months
Count of patients with a flu vaccination during the 2022-2023 season	Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)	Up to 8 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Christopher F Chabris, PhD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): April 8, 2023
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Health Promotion; Vaccination; Health Behavior; Economics, Behavioral; Reminder Systems
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 2022-0419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
• IPD Sharing Time Frame: By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
• IPD Sharing Access Criteria: The data on the Open Science Framework will be open to anyone requesting that information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No