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Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flu shot text messages
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza, Human focused on measuring Influenza vaccination, behavioral science interventions, vaccination promotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Geisinger Health
  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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

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.

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.

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2020
Last Updated
January 25, 2022
Sponsor
University of Pennsylvania
Collaborators
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04565353
Brief Title
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates
Official Title
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Influenza vaccination, behavioral science interventions, vaccination promotion

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
74811 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holdout control
Arm Type
No Intervention
Arm Description
Participants will only receive the standard appointment reminders from their providers.
Arm Title
Default Reservations Opt-Out Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Default Reservations Opt-In Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Intergroup Competition Treatment Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Intergroup Competition Control Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Flu Shot for You Symbolic Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Flu Shot for You Herd Immunity Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Flu Shot for You Control Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Prosocial Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Oriented Condition
Arm Type
Experimental
Arm Description
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).
Arm Title
Information Vivid Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Basic Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Control Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Sharing Humor Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
No Humor Condition
Arm Type
Experimental
Arm Description
The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot.
Arm Title
Healthy Habits Easy Health Behavior Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Habits Difficult Health Behavior Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Habits Control Condition
Arm Type
Experimental
Arm Description
The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot.
Arm Title
Just-In-Time Reminders 24-Hour Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Just-In-Time Reminders 15-Minute Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Flu shot text messages
Intervention Description
Participants will receive text messages per descriptions listed in the arms.
Primary Outcome Measure Information:
Title
Number of Participants With Flu Shot Receipt at or Before Appointment
Description
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 Outcome Measure Information:
Title
Number of Participants With Flu Shot Receipt Before March 31, 2021
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
29383550
Citation
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.
Results Reference
background
PubMed Identifier
21670283
Citation
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.
Results Reference
background
PubMed Identifier
29133488
Citation
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.
Results Reference
background
PubMed Identifier
20036102
Citation
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.
Results Reference
background
PubMed Identifier
35175346
Citation
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.
Results Reference
derived

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Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates

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