Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Flu shot text messages

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

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:

-

Sites / Locations

University of Pennsylvania

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 21

Arm 22

Arm 23

Arm Type

No Intervention

Experimental

Arm Label

Holdout control

Unpacking Risks Treatment

Unpacking Risks Control

Active Commitment Treatment

Active Commitment Control

Self-Generated Social Norms Treatment

Self-Generated Social Norms Control

Foot-in-the-Door Treatment

Foot-in-the-Door Control

Prosocial Condition

Self-Oriented Condition

Prosocial + COVID-19

Self-Oriented + COVID-19

Dynamic + Static Norm

Dynamic Norm

Dynamic Norms Control

Sharing Humor

Humor Placebo

No Humor Condition

Connecting the Past Self to the Future Self Treatment

Connecting the Past Self to the Future Self Control

Reverse Inference Condition

Reverse Inference Control Condition

Arm Description

Participants will only receive the standard pharmacy messaging.

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).

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.

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.

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

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.

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

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.

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

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).

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

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).

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).

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.

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.

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

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.

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.

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

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT04590066

First Posted

October 2, 2020

Last Updated

January 29, 2021

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT04590066

Brief Title

Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy

Official Title

Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

September 25, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

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, 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).

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.

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 and outcomes at the end of the study.

Allocation

Randomized

Enrollment

734383 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Holdout control

Arm Type

No Intervention

Arm Description

Participants will only receive the standard pharmacy messaging.

Arm Title

Unpacking Risks Treatment

Arm Type

Experimental

Arm Description

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).

Arm Title

Unpacking Risks Control

Arm Type

Experimental

Arm Description

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.

Arm Title

Active Commitment Treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Active Commitment Control

Arm Type

Experimental

Arm Description

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

Arm Title

Self-Generated Social Norms Treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Self-Generated Social Norms Control

Arm Type

Experimental

Arm Description

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

Arm Title

Foot-in-the-Door Treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Foot-in-the-Door Control

Arm Type

Experimental

Arm Description

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

Arm Title

Prosocial Condition

Arm Type

Experimental

Arm Description

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).

Arm Title

Self-Oriented Condition

Arm Type

Experimental

Arm Description

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

Arm Title

Prosocial + COVID-19

Arm Type

Experimental

Arm Description

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).

Arm Title

Self-Oriented + COVID-19

Arm Type

Experimental

Arm Description

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).

Arm Title

Dynamic + Static Norm

Arm Type

Experimental

Arm Description

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.

Arm Title

Dynamic Norm

Arm Type

Experimental

Arm Description

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.

Arm Title

Dynamic Norms Control

Arm Type

Experimental

Arm Description

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

Arm Title

Sharing Humor

Arm Type

Experimental

Arm Description

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

Humor Placebo

Arm Type

Experimental

Arm Description

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.

Arm Title

No Humor Condition

Arm Type

Experimental

Arm Description

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

Arm Title

Connecting the Past Self to the Future Self Treatment

Arm Type

Experimental

Arm Description

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.

Arm Title

Connecting the Past Self to the Future Self Control

Arm Type

Experimental

Arm Description

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.

Arm Title

Reverse Inference Condition

Arm Type

Experimental

Arm Description

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.

Arm Title

Reverse Inference Control Condition

Arm Type

Experimental

Arm Description

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.

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

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

Description

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.

Time Frame

98 days

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

37 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

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

Influenza, Human

About this trial

Eligibility Criteria

Sites / Locations

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 21

Arm 22

Arm 23

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial