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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05508698
Other study ID # 2022-0419
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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