Clinical trial NCT04565353: 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
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Keywords: Influenza vaccination
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
First posted: 2020-09-25
Enrollment: 74811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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).

Primary outcomes:
measure: Number of Participants With Flu Shot Receipt at or Before Appointment
timeFrame: 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:
measure: Number of Participants With Flu Shot Receipt Before March 31, 2021
timeFrame: Up to 6 months after randomization.
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References:
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.
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.
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.
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.
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.