CClinicalTrials.gg
CompletedNCT04565353Updated Feb 1, 2022Results posted

Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

An interventional study of Flu shot text messages in Influenza, Human, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
74,811
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research aims to identify which behavioral science strategies are most effective at increasing flu vaccination rates overall and based on patients' individual characteristics. Past behavioral science interventions have shown promise in increasing flu vaccinations. For example, successful interventions have encouraged people to make concrete plans for when they will get a flu vaccination (Milkman et al. 2011), sent automated calls or text messages reminding patients to get a flu vaccination (Cutrona et al. 2018; Regan et al. 2017), or provided financial incentives for getting vaccinated (Nowalk et al. 2010). Although these results are promising, these studies have been conducted in isolation on different populations, which makes it difficult to compare their interventions' effectiveness or to have enough power to reliably detect differing responses to interventions based on individual characteristics.

This research will simultaneously test 19 different SMS interventions to increase flu vaccinations in a "mega-study" and apply machine learning to identify which interventions work best for whom. The interventions are designed by behavioral science experts from the Behavior Change for Good Initiative (BCFG), Penn Medicine Nudge Unit (PMNU), and Geisinger Behavioral Insights Team (BIT). We expect to include at least 80,000 participants.

The specific aims of this research are to identify (1) which behavioral science strategies effectively increase flu vaccination rates overall, and (2) which strategies are most effective for different subgroups (e.g., based on age, gender, race).

02

Conditions studied

  • Influenza, Human

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Keywords

  • Influenza vaccination
  • behavioral science interventions
  • vaccination promotion
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 74,811 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Penn Medicine and Geisinger patients will be included if they:

Inclusion criteria

Inclusion Criteria:

  • Have a cell phone number recorded in a Penn Medicine or Geisinger database
  • Have a new or routine primary care appointment during the study recruitment period (not a sick visit)

Exclusion criteria

Exclusion Criteria:

  • Have documentation of allergy or adverse event to influenza vaccination in medical records
  • Have documentation of already receiving their 2020 influenza vaccination prior to randomization in medical records
  • Have opted out of receiving text message appointment reminders
  • Have asked not to be contacted for research purposes
  • Have an appointment with someone other than their primary care physician
  • Have an appointment with someone other than a physician, resident, nurse practitioner, or physician assistant

We will recruit as many patients as possible starting in September 2020. We will stop enrolling participants with appointments scheduled to occur after December 31, 2020 if we have reached 4,000 participants per condition. If we do not have 4,000 participants per condition by December 31, 2020, we will continue enrolling participants until we have reached 4,000 per condition, or until March 31, 2021 (discontinuing enrollment at whichever milestone arrives sooner - 4,000 people enrolled or 3/31/21).

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
74,811 participants (actual)

Study arms

  • No intervention
    Holdout control

    Participants will only receive the standard appointment reminders from their providers.

  • Experimental
    Default Reservations Opt-Out Condition

    The day before their scheduled appointment, participants receive a text reading: "A flu shot has been reserved for you to receive at your appointment tomorrow. Reply Y if you want this shot held for you, N if you don't." The text will include a picture of a vial that says "Your Flu Shot" on it.

    Behavioral: Flu shot text messages

  • Experimental
    Default Reservations Opt-In Condition

    The day before their scheduled appointment, participants receive a text reading: "Reply Y if you would like to receive a flu shot at your appointment tomorrow, N if not." The text will include a picture of vial with no text on it.

    Behavioral: Flu shot text messages

  • Experimental
    Intergroup Competition Treatment Condition

    Three days before their scheduled appointment, participants will receive a text message with information about how much "your region" lagged behind "another region" in flu shot rate last year ("your region" and "another region" will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Intergroup Competition Control Condition

    Three days before their scheduled appointment, participants will receive a text message with information about how much "your region" lagged behind the target flu shot rate of 70% last year ("your region" will depend on the study site and include realistic flu shot rates based on historical CDC data). Participants will receive a reminder message on the day of the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Flu Shot for You Symbolic Condition

    Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity to dedicate getting the flu shot to someone by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Flu Shot for You Herd Immunity Condition

    Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also be told that they have the opportunity of getting the flu shot to protect a vulnerable loved one by texting back the initials of an individual. Participants will receive a reminder message on the day of the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Flu Shot for You Control Condition

    Three days before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. They will also receive a reminder message on the day of the appointment. They will not receive any further information, nor will they be asked to respond with initials of an individual.

    Behavioral: Flu shot text messages

  • Experimental
    Prosocial Condition

    The day before their scheduled appointment, participants will receive a message describing the pro-social benefits of getting a flu shot, and a reminder to ask for their flu shot. The described pro-social benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting loved ones from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting loved ones from serious complications from the flu). Participants will also receive a reminder message on the day of the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Self-Oriented Condition

    The day before their scheduled appointment, participants will receive a message describing the self-oriented benefits of getting a flu shot, and a reminder to ask for their flu shot. The described self-oriented benefits will vary whether they emphasize the COVID-19 pandemic (e.g., protecting oneself from the risk of hospital-acquired COVID-19 infection) or not (e.g., protecting oneself from serious complications from the flu).

    Behavioral: Flu shot text messages

  • Experimental
    Information Vivid Condition

    Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain vivid information about getting the flu. Participants will also receive a reminder message the day before the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Information Basic Condition

    Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain basic information about getting the flu. Participants will also receive a reminder message the day before the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Information Control Condition

    Three days before their scheduled appointment, participants will receive a message inviting them to watch a 2-minute wellness video and answer some related questions, as well as encouragement to get the flu shot. In this condition, the video will contain information about exercising. Participants will also receive a reminder message the day before the appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Sharing Humor Condition

    The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. The message will include a joke about the flu and will encourage participants to share the joke with nurses, doctors, or pharmacists.

    Behavioral: Flu shot text messages

  • Experimental
    No Humor Condition

    The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.

    Behavioral: Flu shot text messages

  • Experimental
    Healthy Habits Easy Health Behavior Condition

    The day before their scheduled appointment, participants will be asked if they have completed a series of easy health behaviors (e.g., whether they walked 500 feet yesterday, at least two serving of fruits and vegetables in the last week, and slept at least 6 hours the previous night). They will then be encouraged to get a flu shot at their appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Healthy Habits Difficult Health Behavior Condition

    The day before their scheduled appointment, participants will be asked if they have completed a series of difficult health behaviors (e.g., whether they walked 3 miles yesterday, ate 4-6 servings of fruits and vegetables yesterday, and slept at least 9 hours the previous night). They will then be encouraged to get a flu shot at their appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Healthy Habits Control Condition

    The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.

    Behavioral: Flu shot text messages

  • Experimental
    Just-In-Time Reminders 24-Hour Condition

    Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 24 hours before their appointment.

    Behavioral: Flu shot text messages

  • Experimental
    Just-In-Time Reminders 15-Minute Condition

    Just-In-Time Reminders 15-Minute Condition: Seventy-two hours before their appointment, participants will receive a text message alerting them to the availability of the flu vaccine at their upcoming appointment. Participants will be told they'll receive a reminder, which they can opt-out from receiving. The text message reminder will be sent 15 minutes before their appointment.

    Behavioral: Flu shot text messages

Interventions

  • BehavioralFlu shot text messages

    Participants will receive text messages per descriptions listed in the arms.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Flu Shot Receipt at or Before Appointment

    Our field experiment will be conducted with Penn Medicine and Geisinger Health patients via SMS messages sent prior to their first primary care appointment during the study period, hereafter referred to as the "target appointment." The key dependent variable is whether participants receive a flu shot at or before their target appointment (as recorded in their electronic health records). If participants 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 primary care appointment becomes the target appointment. Participants who have been randomized to a treatment will be counted as not having received a flu shot if they cancel or do not show up for their target appointment and do not schedule a new appointment during the study period. Participants who receive a flu shot before they receive the SMS intervention will be excluded from the analyses.

    Time frame: The dependent variable will be assessed during a 4-day period after randomization starting three days prior to the participant's target primary care appointment through the date of the target appointment (including the date of the appointment)

Secondary outcomes

  1. Number of Participants With Flu Shot Receipt Before March 31, 2021

    The secondary dependent variable is whether participants receive the flu shot at or before their target appointment or at any time after this appointment (by March 31, 2021), as recorded in their electronic health records. Participants who receive a flu shot before they receive the SMS intervention will be excluded from the analyses.

    Time frame: Up to 6 months after randomization.

07

Results

Posted Aug 11, 2021

Participant flow

Participant flow — Overall Study
MilestoneHoldout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute Condition
Started37423737370937353758376937193732372837773672375137373714377337393776374437413758
Completed37423688367036933717371636653693366237343623371036853664373636903734369636983712
Not completed049394241535439664349415250374942484346

Outcome measures

PrimaryNumber of Participants With Flu Shot Receipt at or Before Appointment

Our field experiment will be conducted with Penn Medicine and Geisinger Health patients via SMS messages sent prior to their first primary care appointment during the study period, hereafter referred to as the "target appointment." The key dependent variable is whether participants receive a flu shot at or before their target appointment (as recorded in their electronic health records). If participants 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 primary care appointment becomes the target appointment. Participants who have been randomized to a treatment will be counted as not having received a flu shot if they cancel or do not show up for their target appointment and do not schedule a new appointment during the study period. Participants who receive a flu shot before they receive the SMS intervention will be excluded from the analyses.

Time frame:
The dependent variable will be assessed during a 4-day period after randomization starting three days prior to the participant's target primary care appointment through the date of the target appointment (including the date of the appointment)
Reported as:
Count of participants · Participants
Number of Participants With Flu Shot Receipt at or Before Appointment
ParticipantsHoldout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute Condition
Number of Participants With Flu Shot Receipt at or Before Appointment11131210115011631183120011921191115712241144123111711135119911811193113012401227
SecondaryNumber of Participants With Flu Shot Receipt Before March 31, 2021

The secondary dependent variable is whether participants receive the flu shot at or before their target appointment or at any time after this appointment (by March 31, 2021), as recorded in their electronic health records. Participants who receive a flu shot before they receive the SMS intervention will be excluded from the analyses.

Time frame:
Up to 6 months after randomization.
Reported as:
Count of participants · Participants
Number of Participants With Flu Shot Receipt Before March 31, 2021
ParticipantsHoldout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute Condition
Number of Participants With Flu Shot Receipt Before March 31, 202112961391133013431338137113691370136014181316138513421310135113701360129713881388

Adverse events

Collected over 9/20/20 - 3/31/21 -- A period of over six months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Holdout Control———
Default Reservations Opt-Out Condition———
Default Reservations Opt-In Condition———
Intergroup Competition Treatment Condition———
Intergroup Competition Control Condition———
Flu Shot for You Symbolic Condition———
Flu Shot for You Herd Immunity Condition———
Flu Shot for You Control Condition———
Prosocial Condition———
Self-Oriented Condition———
Information Vivid Condition———
Information Basic Condition———
Information Control Condition———
Sharing Humor Condition———
No Humor Condition———
Healthy Habits Easy Health Behavior Condition———
Healthy Habits Difficult Health Behavior Condition———
Healthy Habits Control Condition———
Just-In-Time Reminders 24-Hour Condition———
Just-In-Time Reminders 15-Minute Condition———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Holdout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute ConditionTotal
<=18 years2224212031212115242422312414241916192028440
Between 18 and 65 years2950292029212940294229412916292329322955290229482961295029422927295629322947295958764
>=65 years77079376777578580778279477279874877275275080779380479377477115607
Age, Continuous
Age, Continuous(years)Holdout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute ConditionTotal
Mean50.3 ± 16.250.7 ± 16.450.5 ± 16.350.7 ± 16.250.5 ± 16.250.9 ± 16.350.5 ± 16.450.8 ± 16.650.9 ± 16.250.6 ± 16.250.8 ± 16.150.8 ± 16.150.7 ± 16.150.5 ± 16.250.9 ± 16.351.0 ± 16.351.0 ± 16.050.7 ± 16.350.7 ± 16.250.5 ± 16.050.7 ± 16.2
Sex: Female, Male
Sex: Female, Male(Participants)Holdout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute ConditionTotal
Female2056210920792067209620972018209120832120203021072060210420982085215921202101209141771
Male1686162816301668166216721701164116451657164216441677161016751654161716241640166733040
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Holdout ControlDefault Reservations Opt-Out ConditionDefault Reservations Opt-In ConditionIntergroup Competition Treatment ConditionIntergroup Competition Control ConditionFlu Shot for You Symbolic ConditionFlu Shot for You Herd Immunity ConditionFlu Shot for You Control ConditionProsocial ConditionSelf-Oriented ConditionInformation Vivid ConditionInformation Basic ConditionInformation Control ConditionSharing Humor ConditionNo Humor ConditionHealthy Habits Easy Health Behavior ConditionHealthy Habits Difficult Health Behavior ConditionHealthy Habits Control ConditionJust-In-Time Reminders 24-Hour ConditionJust-In-Time Reminders 15-Minute ConditionTotal
Race category — Asian86829199867587889383909187889384808985771734
Race category — Black75172973668873071771170571975567666771367374167672271469870114222
Race category — Hispanic1871771731681571801561741741771811431771831541601621751451883391
Race category — Other1401141491261341471301161401081391281441311281351131441341382638
Race category — White2578263525602654265126502635264926022654258627222616263926572684269926222679265452826
08

Study locations

2 sites
  • Geisinger Health
    Danville, Pennsylvania 17822, United States
  • University of Pennsylvania Health System
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • Cutrona SL, Golden JG, Goff SL, Ogarek J, Barton B, Fisher L, Preusse P, Sundaresan D, Garber L, Mazor KM. Improving Rates of Outpatient Influenza Vaccination Through EHR Portal Messages and Interactive Automated Calls: A Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):659-667. doi: 10.1007/s11606-017-4266-9. Epub 2018 Jan 30. PubMed 29383550 ↗
  • Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13. PubMed 21670283 ↗
  • Regan AK, Bloomfield L, Peters I, Effler PV. Randomized Controlled Trial of Text Message Reminders for Increasing Influenza Vaccination. Ann Fam Med. 2017 Nov;15(6):507-514. doi: 10.1370/afm.2120. PubMed 29133488 ↗
  • Nowalk MP, Lin CJ, Toback SL, Rousculp MD, Eby C, Raymund M, Zimmerman RK. Improving influenza vaccination rates in the workplace: a randomized trial. Am J Prev Med. 2010 Mar;38(3):237-46. doi: 10.1016/j.amepre.2009.11.011. Epub 2009 Dec 24. PubMed 20036102 ↗
  • Buttenheim A, Milkman KL, Duckworth AL, Gromet DM, Patel M, Chapman G. Effects of Ownership Text Message Wording and Reminders on Receipt of an Influenza Vaccination: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2143388. doi: 10.1001/jamanetworkopen.2021.43388. PubMed 35175346 ↗

Study documents

  • Study protocol · Jun 11, 2021
  • Statistical analysis plan · Jul 15, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Aggregate data and code used for analyses conducted on participants enrolled from September through December is available at https://osf.io/tucjs/?view_only=c491df37a33840abbdedda4e60176f34. This reflects the analyses and data included in this paper: https://www.pnas.org/content/118/20/e2101165118. Researchers interested in using individual-level data to replicate our results should contact the Behavior Change for Good Initiative at the University of Pennsylvania (bcfg@wharton.upenn.edu) and must sign a standard medical data nondisclosure agreement to access the data on a protected medical server.

Supporting information: Study protocol, Sap, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04565353
Lead sponsor
University of Pennsylvania
Collaborators
Geisinger Clinic
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Sep 20, 2020
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Results posted
Aug 11, 2021
Last update
Feb 1, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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