Influenza, HumanNCT04565353
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates
A study testing Flu shot text messages in people with Influenza, Human, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Flu shot text messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74,811 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Health
Danville, Pennsylvania, 17822
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
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).
- Conditions
- Influenza, Human
- Being tested
- Flu shot text messages
- Keywords
- Influenza vaccination, behavioral science interventions, vaccination promotion
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu shot text messagesBehavioural
Participants will receive text messages per descriptions listed in the arms.
| Study group | Role | What they receive |
|---|---|---|
| Holdout control | No intervention | Participants will only receive the standard appointment reminders from their providers. |
| Default Reservations Opt-Out Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Default Reservations Opt-In Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Intergroup Competition Treatment Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Intergroup Competition Control Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Flu Shot for You Symbolic Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Flu Shot for You Herd Immunity Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Flu Shot for You Control Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Prosocial Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Self-Oriented Condition | Experimental | 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). Receives: Behavioral: Flu shot text messages |
| Information Vivid Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Information Basic Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Information Control Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Sharing Humor Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| No Humor Condition | Experimental | The day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. Receives: Behavioral: Flu shot text messages |
| Healthy Habits Easy Health Behavior Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Healthy Habits Difficult Health Behavior Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Healthy Habits Control Condition | Experimental | The day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. Receives: Behavioral: Flu shot text messages |
| Just-In-Time Reminders 24-Hour Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
| Just-In-Time Reminders 15-Minute Condition | Experimental | 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. Receives: Behavioral: Flu shot text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start20 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 74,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565353
- Sponsor's protocol ID
- 843523
- Status last verified
- Jan 2022
- First submitted
- 10 Sep 2020
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 29383550Milkman 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 21670283Regan 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 29133488Nowalk 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 20036102Buttenheim 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 at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates
- ClinicalTrials.gov ID
- NCT04565353
- Acronym / sponsor ID
- 843523
- Conditions
- Influenza, Human
- Keywords
- Influenza vaccination, behavioral science interventions, vaccination promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74,811 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Geisinger Clinic
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 11 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 20
- 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).
| Arm | Type | Receives |
|---|---|---|
| Holdout control | No intervention | –Participants will only receive the standard appointment reminders from their providers. |
| Default Reservations Opt-Out Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| Default Reservations Opt-In Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| Intergroup Competition Treatment Condition | Experimental | Behavioral: Flu shot text messagesThree 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. |
| Intergroup Competition Control Condition | Experimental | Behavioral: Flu shot text messagesThree 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 for You Symbolic Condition | Experimental | Behavioral: Flu shot text messagesThree 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 for You Herd Immunity Condition | Experimental | Behavioral: Flu shot text messagesThree 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 for You Control Condition | Experimental | Behavioral: Flu shot text messagesThree 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. |
| Prosocial Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| Self-Oriented Condition | Experimental | Behavioral: Flu shot text messagesThe 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). |
| Information Vivid Condition | Experimental | Behavioral: Flu shot text messagesThree 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. |
| Information Basic Condition | Experimental | Behavioral: Flu shot text messagesThree 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. |
| Information Control Condition | Experimental | Behavioral: Flu shot text messagesThree 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. |
| Sharing Humor Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| No Humor Condition | Experimental | Behavioral: Flu shot text messagesThe day before their scheduled appointment, participants will receive a text message encouraging them to get the flu shot. |
| Healthy Habits Easy Health Behavior Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| Healthy Habits Difficult Health Behavior Condition | Experimental | Behavioral: Flu shot text messagesThe 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. |
| Healthy Habits Control Condition | Experimental | Behavioral: Flu shot text messagesThe day before their scheduled appointment, participants will receive a text message encouraging them to get a flu shot. |
| Just-In-Time Reminders 24-Hour Condition | Experimental | Behavioral: Flu shot text messagesSeventy-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 | Experimental | Behavioral: Flu shot text messagesJust-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu shot text messagesParticipants will receive text messages per descriptions listed in the arms. | Behavioural | Default Reservations Opt-In Condition, Default Reservations Opt-Out Condition, Flu Shot for You Control Condition, Flu Shot for You Herd Immunity Condition, Flu Shot for You Symbolic Condition, Healthy Habits Control Condition, Healthy Habits Difficult Health Behavior Condition, Healthy Habits Easy Health Behavior Condition, Information Basic Condition, Information Control Condition, Information Vivid Condition, Intergroup Competition Control Condition, Intergroup Competition Treatment Condition, Just-In-Time Reminders 15-Minute Condition, Just-In-Time Reminders 24-Hour Condition, No Humor Condition, Prosocial Condition, Self-Oriented Condition, Sharing Humor Condition |
Primary outcome
Number of Participants With Flu Shot Receipt at or Before Appointment
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)
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.
1 secondary outcome
Number of Participants With Flu Shot Receipt Before March 31, 2021
Time frame: Up to 6 months after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29383550Cutrona 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.
- Background: PubMed 21670283Milkman 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.
- Background: PubMed 29133488Regan 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.
- Background: PubMed 20036102Nowalk 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.
- Derived from this study: PubMed 35175346Buttenheim 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flu shot text messages in people with Influenza, Human, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Flu Shot Receipt at or Before Appointment (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565353, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.