NCT06566534

Brief Summary

The purpose of this study is to prospectively test whether personalized, message-based nudges can increase flu vaccination compared with nudges that are not personalized or no nudges.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77,482

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

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 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

August 20, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

vaccinationhealth promotionhealth behaviorreminder systemsbehavioral economicsbehavioral risk assessmentmachine learningpersonalizationnudges

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Flu Shot Receipt Between Enrollment Date and Target Appointment Date

    Our field experiment will be conducted with Geisinger Health patients via SMS messages sent prior to their first flu shot-eligible appointment during the study period, referred to as the "target appointment." The key dependent variable is whether patients receive a flu shot at or before their target appointment (as recorded in their electronic health records). If patients cancel or do not show up for their target appointment after they have been randomized to a treatment and then schedule a new appointment during the study period, their new flu-shot eligible appointment becomes the target appointment and the outcome window extends from three days prior to the original appointment through the date of the appointment. Patients who miss their target appointment and do not reschedule within the study period will still be included in the analysis. Their outcome window is from three days prior to the original appointment through the date of the original canceled appointment.

    Between the enrollment date and target appointment date (at least 4 days and up to 4 months)

Other Outcomes (4)

  • Number of Patients With Flu Shot Receipt On or Before December 31, 2024

    Up to 4 months after randomization

  • Number of Patients with Flu Shot Receipt Between Enrollment Date and First Eligible Appointment

    4 Days

  • Number of Patients with Flu Diagnosis (encounter diagnosis or flu test)

    Up to 8 months after randomization

  • +1 more other outcomes

Study Arms (4)

Passive Control

NO INTERVENTION

Patients randomized to this arm will receive no special communications, beyond what Geisinger sends out as standard practice.

Active Control

EXPERIMENTAL

Patients will receive a simple message encouraging them to get a flu shot at their appointment.

Behavioral: Reminder

Best Nudge

EXPERIMENTAL

Patients will receive the nudge found to be numerically most effective in the megastudy, including language that a flu vaccine is "reserved" for them at their upcoming appointment.

Behavioral: Reminder

Personalized Nudge

EXPERIMENTAL

Patients will receive the nudge predicted to be most effective for them on the basis of the machine learning-derived treatment assignment trees.

Behavioral: Reminder

Interventions

ReminderBEHAVIORAL

Flu shot messages via SMS

Active ControlBest NudgePersonalized Nudge

Eligibility Criteria

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

You may qualify if:

  • Age 18+
  • Has not received the 2024 flu vaccine according to the Geisinger electronic health record (EHR) prior to randomization
  • Has a non-acute, flu-shot eligible, in-person Geisinger appointment scheduled with enough time to be randomized
  • Has a Geisinger primary care provider

You may not qualify if:

  • Cannot be contacted by SMS (e.g., due to insufficient/missing contact information in the EHR or because they opted out)
  • Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach
  • Has an allergy to flu vaccines according to any EHR allergy table known to the study team
  • Has a health maintenance modifier indicating they are permanently discontinued from receiving a seasonal flu shot
  • Shares a phone number with someone who has already been enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Related Publications (2)

  • Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.

    PMID: 33926993BACKGROUND
  • Patel MS, Milkman KL, Gandhi L, Graci HN, Gromet D, Ho H, Kay JS, Lee TW, Rothschild J, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris C, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Lee SH, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A Randomized Trial of Behavioral Nudges Delivered Through Text Messages to Increase Influenza Vaccination Among Patients With an Upcoming Primary Care Visit. Am J Health Promot. 2023 Mar;37(3):324-332. doi: 10.1177/08901171221131021. Epub 2022 Oct 4.

    PMID: 36195982BACKGROUND

Related Links

MeSH Terms

Conditions

Influenza, HumanHealth Behavior

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Christopher F Chabris, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Although patients will not be explicitly informed of which arm they were randomized to, they will be aware of the messages they receive. The care provider will be provided an information sheet describing the intervention, but they will not be explicitly told which patients are enrolled or their randomized arm assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start

September 9, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

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