Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04590066
Other study ID # 843523-Trial B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 734383
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Have agreed to receive SMS messages from the pharmacy 2. Received a flu shot from the pharmacy in the 2019-2020 flu season, as documented in their pharmacy records. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Flu shot text messages
Participants will receive text messages per descriptions listed in the arms.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
37 days
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Completed NCT03275389 - A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years Phase 1
Completed NCT05981846 - A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19 Phase 2
Completed NCT05044195 - A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age Phase 3
Completed NCT02914275 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. Phase 3
Recruiting NCT03778203 - Development of Childhood Anti-influenza Immunity Phase 4
Completed NCT04527614 - Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection N/A
Terminated NCT03658629 - Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults Phase 2
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Completed NCT02998996 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU Phase 1/Phase 2
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
Completed NCT02545543 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age Phase 3
Completed NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents Phase 3
Completed NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02212106 - A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years Phase 4
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3
Completed NCT01674205 - Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines Phase 1