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Completed

NCT Number: NCT05508698

Flu Shot Pre-visit Questionnaire

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.

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Key information

Conditions

Influenza Behavior Health Behavior Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Precommitment Nudge

Behavioral

Ask participants to commit to a decision about getting a flu shot

Salience

Behavioral

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 outcomes

  1. Count of patients with a flu vaccination

    Time frame: Up to 21 days

    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.

Other outcomes

  1. Count of patients with a high confidence flu diagnosis

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 11 months

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

  5. Hospitalizations

    Time frame: Up to 11 months

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

  6. COVID-19 vaccination rates

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Pre-visit Questionnaire to Increase Influenza Vaccinations

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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