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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Control | No Intervention | No change to the standard of care for flu vaccines | |
| Pre-visit Questionnaire | Experimental | One-item questionnaire in online patient portal and additional information in the flu shot alert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precommitment Nudge | Behavioral | Ask participants to commit to a decision about getting a flu shot |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Count of patients with a "likely flu" diagnosis |
Patient Inclusion Criteria:
Clinician Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christopher F Chabris, PhD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
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.
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
The data on the Open Science Framework will be open to anyone requesting that information.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2023 | Jul 21, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D015438 | Health Behavior |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Patient-participants will not be explicitly told about the different arms, although clinician-participants will see the different arms and may notice these differences.
| 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 |
|
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 |
| 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 |
| ER visits | Number of ER visits from the patient's message appointment date through July 31, 2023 | Up to 11 months |
| Hospitalizations | Number of hospitalizations from the patient's message appointment date through July 31, 2023 | Up to 11 months |
| 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 |
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |