Back to resultsFlu Shot Pre-visit Questionnaire
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precommitment Nudge
Salience
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral
Eligibility Criteria
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
Clinician Inclusion Criteria
- Any Geisinger clinician who sees patient-participants in our study for a flu shot-eligible outpatient visit
Sites / Locations
- Geisinger Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Passive Control
Pre-visit Questionnaire
Arm Description
No change to the standard of care for flu vaccines
One-item questionnaire in online patient portal and additional information in the flu shot alert
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05508698
Brief Title
Flu Shot Pre-visit Questionnaire
Official Title
Pre-visit Questionnaire to Increase Influenza Vaccinations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2022 (Actual)
Primary Completion Date
April 8, 2023 (Actual)
Study Completion Date
April 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Vaccination, Health Promotion, Health Behavior, Reminder Systems, Economics, Behavioral
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patient-participants will not be explicitly told about the different arms, although clinician-participants will see the different arms and may notice these differences.
Allocation
Randomized
Enrollment
230962 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
No change to the standard of care for flu vaccines
Arm Title
Pre-visit Questionnaire
Arm Type
Experimental
Arm Description
One-item questionnaire in online patient portal and additional information in the flu shot alert
Intervention Type
Behavioral
Intervention Name(s)
Precommitment Nudge
Intervention Description
Ask participants to commit to a decision about getting a flu shot
Intervention Type
Behavioral
Intervention Name(s)
Salience
Intervention Description
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
Primary Outcome Measure Information:
Title
Count of patients with a flu vaccination
Description
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.
Time Frame
Up to 21 days
Other Pre-specified Outcome Measures:
Title
Count of patients with a high confidence flu diagnosis
Description
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)
Time Frame
Up to 8 months
Title
Count of patients with a "likely flu" diagnosis
Description
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
Time Frame
Up to 8 months
Title
Count of patients with flu complications
Description
Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Time Frame
Up to 8 months
Title
ER visits
Description
Number of ER visits from the patient's message appointment date through July 31, 2023
Time Frame
Up to 11 months
Title
Hospitalizations
Description
Number of hospitalizations from the patient's message appointment date through July 31, 2023
Time Frame
Up to 11 months
Title
COVID-19 vaccination rates
Description
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)
Time Frame
Up to 8 months
Title
Count of patients with a flu vaccination during the 2022-2023 season
Description
Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)
Time Frame
Up to 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher F Chabris, PhD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Flu Shot Pre-visit Questionnaire
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