- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04590066
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
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, sent automated calls or text messages reminding patients to get a flu vaccination , or provided financial incentives for getting vaccinated. 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 22 different SMS interventions to increase flu vaccinations compared to a holdout control condition 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). Customers of a large retail pharmacy who received a flu shot from the pharmacy last year and receive SMS notifications will be included in this study. We expect this to include approximately 1.2 million 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have agreed to receive SMS messages from the pharmacy
- Received a flu shot from the pharmacy in the 2019-2020 flu season, as documented in their pharmacy records.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Holdout control
Participants will only receive the standard pharmacy messaging.
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EXPERIMENTAL: Unpacking Risks Treatment
Participants will be asked to think about the risks of catching the flu this flu season and to respond with the location they are most likely to catch the flu out of a list of given options (e.g. at work, at home).
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Unpacking Risks Control
Participants will be asked to think about the risks of catching the flu this flu season and to respond to confirm that they have received the message.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Active Commitment Treatment
Participants receive a gain framed notification that they are eligible for a flu shot.
In addition, participants are told "Many people find it helpful to make a plan to get their shot" and are asked to commit by texting back "I will get a flu shot."
Depending on their response, participants receive a general reminder or a commitment reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Active Commitment Control
Participants receive a gain framed notification that they are eligible for a flu shot.
Participants receive a general reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Self-Generated Social Norms Treatment
Participants will first receive a message enjoining them to consider 2 peers who would want them to vaccinate.
Then they will be asked to do those peers a favor by getting a vaccine at their next opportunity.
They will receive a reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Self-Generated Social Norms Control
articipants will be informed of the opportunity to receive a flu vaccine at their appointment.
They will receive a reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Foot-in-the-Door Treatment
Participants will first receive a message enjoining them to encourage someone else to receive a flu vaccine this year.
They will then be given a message that they might copy-paste to forward to friends, thereby lowering the effort costs of messaging others.
They will receive a reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Foot-in-the-Door Control
Participants will be informed of the opportunity to receive a flu vaccine at their appointment.
They will receive a reminder 3 days later.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Prosocial Condition
Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot.
The message will also give prosocial reasons for vaccinating (i.e., protecting loved ones; preserving scarce resources).
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Self-Oriented Condition
Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Prosocial + COVID-19
Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot.
The message will also give prosocial reasons for vaccinating (e.g., protecting loved ones; preserving scarce resources).
The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources).
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Self-Oriented + COVID-19
Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot.
The message will also emphasize the pandemic (e.g., risk of hospital-acquired COVID-19 infection; wasting scarce resources).
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Dynamic + Static Norm
Participants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before and how many Americans got their flu shot last year.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Dynamic Norm
Participants will receive a text message encouraging them to get a flu shot and informing them that more American adults are getting their flu shot than ever before.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Dynamic Norms Control
Participants will only receive a text message encouraging them to get a flu shot.
They will not receive any norm information.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Sharing Humor
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.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Humor Placebo
Participants will receive a text message encouraging them to get the flu shot.
This message will include the same joke but participants will not be encouraged to share it.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: No Humor Condition
Participants will receive a text message encouraging them to get the flu shot.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Connecting the Past Self to the Future Self Treatment
Participants will receive a text message prompt to recall the negative experience of getting sick.
When asked, "Do you wish you could have avoided getting sick by getting a simple shot?", participants will have the chance to respond Y for yes or N for no.
Regardless of their response, they will be prompted with a second text message to connect their past experience with present-day opportunities for preventative care (getting a flu shot) to protect the future self from the flu.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Connecting the Past Self to the Future Self Control
In the first text message, participants will receive a simple text message encouragement to receive a flu shot.
In the second text message, they will receive a reminder of the appointment time and provider name.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Reverse Inference Condition
Participants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are healthier, wealthier, and more educated.
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Participants will receive text messages per descriptions listed in the arms.
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EXPERIMENTAL: Reverse Inference Control Condition
Participants will receive a text message encouraging them to get a flu shot and informing them that Americans who get flu shots are less likely to get the flu.
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Participants will receive text messages per descriptions listed in the arms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether participants receive a flu shot vaccination at our pharmacy partner by December 31, 2020
Time Frame: 98 days
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The primary outcome measure is whether participants receive a flu shot at our retail pharmacy partner by December 31, 2020 (as recorded in their pharmacy records) after receiving the SMS intervention on September 25, 2020. Participants who receive a flu shot before September 25, 2020 when they received the SMS intervention will be excluded from the analyses. |
98 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether participants receive a flu shot vaccination at our pharmacy partner by October 31, 2020
Time Frame: 37 days
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The secondary outcome measure is whether participants receive a flu shot at our retail pharmacy partner by October 31, 2020 (as recorded in their pharmacy records) after receiving the SMS intervention on September 25, 2020. Participants who receive a flu shot before they receive the SMS intervention on September 25, 2020 will be excluded from the analyses. |
37 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 843523-Trial B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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