Flu Shot Pre-visit Questionnaire

Sponsor
Geisinger Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05508698
Collaborator
(none)
165,000
2
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Precommitment Nudge
  • Behavioral: Salience
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
165000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Primary Purpose:
Prevention
Official Title:
Pre-visit Questionnaire to Increase Influenza Vaccinations
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Count of patients with a flu vaccination [Up to 21 days]

    Patient received a flu vaccine (yes/no) in the 21 days after pre-visit questionnaires become available for the patient's first scheduled flu-shot-eligible appointment. Questionnaires are available 14 days prior to the appointment date. Note that control patients will not receive a flu shot questionnaire, but they may receive other questionnaires from the health system 14 days before their appointment. The investigators will also conduct subgroup analyses for people who have previously responded to MyGeisinger pre-visit messages in the previous year and those who have not.

Other Outcome Measures

  1. Count of patients with a high confidence flu diagnosis [Up to 8 months]

    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)

  2. Count of patients with a "likely flu" diagnosis [Up to 8 months]

    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

  3. Count of patients with flu complications [Up to 8 months]

    Diagnosed with flu-related complications (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)

  4. ER visits [Up to 11 months]

    Number of ER visits from the patient's message appointment date through July 31, 2023

  5. Hospitalizations [Up to 11 months]

    Number of hospitalizations from the patient's message appointment date through July 31, 2023

  6. COVID-19 vaccination rates [Up to 8 months]

    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)

  7. Count of patients with a flu vaccination during the 2022-2023 season [Up to 8 months]

    Patient receives a flu vaccine (yes/no) during the 2022-23 flu season (from the patient's appointment date through April 30, 2023)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Geisinger Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher F Chabris, PhD, Professor, Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT05508698
Other Study ID Numbers:
  • 2022-0419
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christopher F Chabris, PhD, Professor, Geisinger Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022