NCT04590066

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, 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
734,383

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

October 2, 2020

Last Update Submit

January 29, 2021

Conditions

Keywords

Influenza vaccinationbehavioral science interventionsvaccination promotion

Outcome Measures

Primary Outcomes (1)

  • Whether participants receive a flu shot vaccination at our pharmacy partner by December 31, 2020

    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

Secondary Outcomes (1)

  • Whether participants receive a flu shot vaccination at our pharmacy partner by October 31, 2020

    37 days

Study Arms (23)

Holdout control

NO INTERVENTION

Participants will only receive the standard pharmacy messaging.

Unpacking Risks Treatment

EXPERIMENTAL

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).

Behavioral: Flu shot text messages

Unpacking Risks Control

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Active Commitment Treatment

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Active Commitment Control

EXPERIMENTAL

Participants receive a gain framed notification that they are eligible for a flu shot. Participants receive a general reminder 3 days later.

Behavioral: Flu shot text messages

Self-Generated Social Norms Treatment

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Self-Generated Social Norms Control

EXPERIMENTAL

articipants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later.

Behavioral: Flu shot text messages

Foot-in-the-Door Treatment

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Foot-in-the-Door Control

EXPERIMENTAL

Participants will be informed of the opportunity to receive a flu vaccine at their appointment. They will receive a reminder 3 days later.

Behavioral: Flu shot text messages

Prosocial Condition

EXPERIMENTAL

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).

Behavioral: Flu shot text messages

Self-Oriented Condition

EXPERIMENTAL

Participants will receive a message describing the condition-specific benefit of getting a flu shot, and a reminder to ask for their flu shot.

Behavioral: Flu shot text messages

Prosocial + COVID-19

EXPERIMENTAL

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).

Behavioral: Flu shot text messages

Self-Oriented + COVID-19

EXPERIMENTAL

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).

Behavioral: Flu shot text messages

Dynamic + Static Norm

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Dynamic Norm

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Dynamic Norms Control

EXPERIMENTAL

Participants will only receive a text message encouraging them to get a flu shot. They will not receive any norm information.

Behavioral: Flu shot text messages

Sharing Humor

EXPERIMENTAL

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

Behavioral: Flu shot text messages

Humor Placebo

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

No Humor Condition

EXPERIMENTAL

Participants will receive a text message encouraging them to get the flu shot.

Behavioral: Flu shot text messages

Connecting the Past Self to the Future Self Treatment

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Connecting the Past Self to the Future Self Control

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Reverse Inference Condition

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Reverse Inference Control Condition

EXPERIMENTAL

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.

Behavioral: Flu shot text messages

Interventions

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

Active Commitment ControlActive Commitment TreatmentConnecting the Past Self to the Future Self ControlConnecting the Past Self to the Future Self TreatmentDynamic + Static NormDynamic NormDynamic Norms ControlFoot-in-the-Door ControlFoot-in-the-Door TreatmentHumor PlaceboNo Humor ConditionProsocial + COVID-19Prosocial ConditionReverse Inference ConditionReverse Inference Control ConditionSelf-Generated Social Norms ControlSelf-Generated Social Norms TreatmentSelf-Oriented + COVID-19Self-Oriented ConditionSharing HumorUnpacking Risks ControlUnpacking Risks Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

    PMID: 29383550BACKGROUND
  • 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.

    PMID: 21670283BACKGROUND
  • 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.

    PMID: 29133488BACKGROUND
  • 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.

    PMID: 20036102BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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 and outcomes at the end of the study.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to the different arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 19, 2020

Study Start

September 25, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations