NCT05508698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230,962

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

August 16, 2022

Last Update Submit

July 21, 2023

Conditions

Keywords

VaccinationHealth PromotionHealth BehaviorReminder SystemsEconomics, Behavioral

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (7)

  • Count of patients with a high confidence flu diagnosis

    Up to 8 months

  • Count of patients with a "likely flu" diagnosis

    Up to 8 months

  • Count of patients with flu complications

    Up to 8 months

  • +4 more other outcomes

Study Arms (2)

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

Behavioral: Precommitment NudgeBehavioral: Salience

Interventions

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

Pre-visit Questionnaire
SalienceBEHAVIORAL

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

Pre-visit Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Any Geisinger clinician who sees patient-participants in our study for a flu shot-eligible outpatient visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Influenza, HumanHealth BehaviorBehavior

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Christopher F Chabris, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient-participants will not be explicitly told about the different arms, although clinician-participants will see the different arms and may notice these differences.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 19, 2022

Study Start

August 18, 2022

Primary Completion

April 8, 2023

Study Completion

April 8, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.

Locations