Flu Shot Pre-visit Questionnaire

Influenza Clinical Trial

Official title:

Pre-visit Questionnaire to Increase Influenza Vaccinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508698
• Other study ID #: 2022-0419
• Status: Completed
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: April 8, 2023

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230962
• Est. completion date: April 8, 2023
• Est. primary completion date: April 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Behavioral:
• Precommitment Nudge
Ask participants to commit to a decision about getting a flu shot
• 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

Locations

Country	Name	City	State
United States	Geisinger Clinic	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	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
Other	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
Other	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
Other	ER visits	Number of ER visits from the patient's message appointment date through July 31, 2023	Up to 11 months
Other	Hospitalizations	Number of hospitalizations from the patient's message appointment 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 appointment date through April 30, 2023)	Up to 8 months
Other	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
Primary	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