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Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565353
Enrollment
74811
Registered
2020-09-25
Start date
2020-09-20
Completion date
2021-03-31
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

Keywords

Influenza vaccination, behavioral science interventions, vaccination promotion

Brief 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).

Interventions

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

Sponsors

Geisinger Clinic
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

As treated participants will receive text messages, there is no scope for blinding. Care providers will not be made aware of subjects' participation in the study, or assigned treatment arms. The study team will only receive data on subjects' assigned arms at the end of the study.

Intervention model description

Participants will be randomly assigned to the different arms. Randomization will be stratified by age (65+ vs. 18-64), vaccine receipt in 2019-2020 flu season (yes vs. no/unknown), and study site (Penn Medicine vs. Geisinger).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Penn Medicine and Geisinger patients will be included if they: 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

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Flu Shot Receipt at or Before AppointmentThe 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)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.

Secondary

MeasureTime frameDescription
Number of Participants With Flu Shot Receipt Before March 31, 2021Up to 6 months after randomization.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.

Countries

United States

Participant flow

Pre-assignment details

A small number of patients in each experimental condition did not receive any intervention messages due to technical malfunctions. These patients are excluded from analyses since they were, for all practical purposes, not a part of of our study

Participants by arm

ArmCount
Holdout Control
Participants will only receive the standard appointment reminders from their providers.
3,742
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,737
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,709
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,735
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,758
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,769
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,719
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,732
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,728
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). Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,777
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,672
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,751
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,737
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,714
No Humor Condition
The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,773
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,739
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,776
Healthy Habits Control Condition
The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,744
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,741
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. Flu shot text messages: Participants will receive text messages per descriptions listed in the arms.
3,758
Total74,811

Baseline characteristics

CharacteristicDefault 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 ConditionHoldout ControlInformation 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
Age, Categorical
<=18 years
24 Participants21 Participants20 Participants31 Participants21 Participants21 Participants15 Participants24 Participants24 Participants22 Participants22 Participants31 Participants24 Participants14 Participants24 Participants19 Participants16 Participants19 Participants20 Participants28 Participants440 Participants
Age, Categorical
>=65 years
793 Participants767 Participants775 Participants785 Participants807 Participants782 Participants794 Participants772 Participants798 Participants748 Participants770 Participants772 Participants752 Participants750 Participants807 Participants793 Participants804 Participants793 Participants774 Participants771 Participants15607 Participants
Age, Categorical
Between 18 and 65 years
2920 Participants2921 Participants2940 Participants2942 Participants2941 Participants2916 Participants2923 Participants2932 Participants2955 Participants2902 Participants2950 Participants2948 Participants2961 Participants2950 Participants2942 Participants2927 Participants2956 Participants2932 Participants2947 Participants2959 Participants58764 Participants
Age, Continuous50.7 years
STANDARD_DEVIATION 16.4
50.5 years
STANDARD_DEVIATION 16.3
50.7 years
STANDARD_DEVIATION 16.2
50.5 years
STANDARD_DEVIATION 16.2
50.9 years
STANDARD_DEVIATION 16.3
50.5 years
STANDARD_DEVIATION 16.4
50.8 years
STANDARD_DEVIATION 16.6
50.9 years
STANDARD_DEVIATION 16.2
50.6 years
STANDARD_DEVIATION 16.2
50.8 years
STANDARD_DEVIATION 16.1
50.3 years
STANDARD_DEVIATION 16.2
50.8 years
STANDARD_DEVIATION 16.1
50.7 years
STANDARD_DEVIATION 16.1
50.5 years
STANDARD_DEVIATION 16.2
50.9 years
STANDARD_DEVIATION 16.3
51.0 years
STANDARD_DEVIATION 16.3
51.0 years
STANDARD_DEVIATION 16
50.7 years
STANDARD_DEVIATION 16.3
50.7 years
STANDARD_DEVIATION 16.2
50.5 years
STANDARD_DEVIATION 16
50.7 years
STANDARD_DEVIATION 16.2
Race/Ethnicity, Customized
Race category
Asian
82 Participants91 Participants99 Participants86 Participants75 Participants87 Participants88 Participants93 Participants83 Participants90 Participants86 Participants91 Participants87 Participants88 Participants93 Participants84 Participants80 Participants89 Participants85 Participants77 Participants1734 Participants
Race/Ethnicity, Customized
Race category
Black
729 Participants736 Participants688 Participants730 Participants717 Participants711 Participants705 Participants719 Participants755 Participants676 Participants751 Participants667 Participants713 Participants673 Participants741 Participants676 Participants722 Participants714 Participants698 Participants701 Participants14222 Participants
Race/Ethnicity, Customized
Race category
Hispanic
177 Participants173 Participants168 Participants157 Participants180 Participants156 Participants174 Participants174 Participants177 Participants181 Participants187 Participants143 Participants177 Participants183 Participants154 Participants160 Participants162 Participants175 Participants145 Participants188 Participants3391 Participants
Race/Ethnicity, Customized
Race category
Other
114 Participants149 Participants126 Participants134 Participants147 Participants130 Participants116 Participants140 Participants108 Participants139 Participants140 Participants128 Participants144 Participants131 Participants128 Participants135 Participants113 Participants144 Participants134 Participants138 Participants2638 Participants
Race/Ethnicity, Customized
Race category
White
2635 Participants2560 Participants2654 Participants2651 Participants2650 Participants2635 Participants2649 Participants2602 Participants2654 Participants2586 Participants2578 Participants2722 Participants2616 Participants2639 Participants2657 Participants2684 Participants2699 Participants2622 Participants2679 Participants2654 Participants52826 Participants
Sex: Female, Male
Female
2109 Participants2079 Participants2067 Participants2096 Participants2097 Participants2018 Participants2091 Participants2083 Participants2120 Participants2030 Participants2056 Participants2107 Participants2060 Participants2104 Participants2098 Participants2085 Participants2159 Participants2120 Participants2101 Participants2091 Participants41771 Participants
Sex: Female, Male
Male
1628 Participants1630 Participants1668 Participants1662 Participants1672 Participants1701 Participants1641 Participants1645 Participants1657 Participants1642 Participants1686 Participants1644 Participants1677 Participants1610 Participants1675 Participants1654 Participants1617 Participants1624 Participants1640 Participants1667 Participants33040 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
EG015
affected / at risk
EG016
affected / at risk
EG017
affected / at risk
EG018
affected / at risk
EG019
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holdout ControlNumber of Participants With Flu Shot Receipt at or Before Appointment1113 Participants
Default Reservations Opt-Out ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1210 Participants
Default Reservations Opt-In ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1150 Participants
Intergroup Competition Treatment ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1163 Participants
Intergroup Competition Control ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1183 Participants
Flu Shot for You Symbolic ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1200 Participants
Flu Shot for You Herd Immunity ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1192 Participants
Flu Shot for You Control ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1191 Participants
Prosocial ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1157 Participants
Self-Oriented ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1224 Participants
Information Vivid ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1144 Participants
Information Basic ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1231 Participants
Information Control ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1171 Participants
Sharing Humor ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1135 Participants
No Humor ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1199 Participants
Healthy Habits Easy Health Behavior ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1181 Participants
Healthy Habits Difficult Health Behavior ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1193 Participants
Healthy Habits Control ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1130 Participants
Just-In-Time Reminders 24-Hour ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1240 Participants
Just-In-Time Reminders 15-Minute ConditionNumber of Participants With Flu Shot Receipt at or Before Appointment1227 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holdout ControlNumber of Participants With Flu Shot Receipt Before March 31, 20211296 Participants
Default Reservations Opt-Out ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211391 Participants
Default Reservations Opt-In ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211330 Participants
Intergroup Competition Treatment ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211343 Participants
Intergroup Competition Control ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211338 Participants
Flu Shot for You Symbolic ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211371 Participants
Flu Shot for You Herd Immunity ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211369 Participants
Flu Shot for You Control ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211370 Participants
Prosocial ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211360 Participants
Self-Oriented ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211418 Participants
Information Vivid ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211316 Participants
Information Basic ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211385 Participants
Information Control ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211342 Participants
Sharing Humor ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211310 Participants
No Humor ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211351 Participants
Healthy Habits Easy Health Behavior ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211370 Participants
Healthy Habits Difficult Health Behavior ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211360 Participants
Healthy Habits Control ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211297 Participants
Just-In-Time Reminders 24-Hour ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211388 Participants
Just-In-Time Reminders 15-Minute ConditionNumber of Participants With Flu Shot Receipt Before March 31, 20211388 Participants

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026