Clinical trial NCT03287830: Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine
Official title: Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Vaccination
Keywords: text message
Short message service (SMS)
mHealth
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: American Academy of Pediatrics
name: Children's Hospital of Philadelphia
First posted: 2017-09-19
Enrollment: 2105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

Detailed description: The study is to be conducted over the 1st season (September 2017-April 2018) as an effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. Eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. Current recommendations require 2 doses for certain children 6 months through 8 years old. Within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (Spanish, English).

Eligibility criteria: Inclusion Criteria:

* Parenting adult (or legal guardian) of a child that:

  * is between 6 months through 8 years at the time of enrollment (or the age for which 2 doses of influenza are recommended should Centers for Disease Control and Prevention (CDC) recommendations change)
  * received 1st dose of influenza vaccine within last 7 days
  * receives care at study site
  * needs 2 doses of influenza vaccine that season as determined by their clinician at the study site
  * plan to continue to receive care through April 30 of that season (to the best of their knowledge) (season 2017-18 only)
* Ability to speak and read English or Spanish
* Has a cell phone that has text message capability

Exclusion Criteria:

* Parenting adult of a child that:

  * already enrolled in the study in this or the previous season
  * will leave practice before end of season (April 30) (to their best knowledge) (2017-18 season only)
* Was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only)
* Unable to speak and read English or speak and read Spanish
* Unable to receive or read text messages on their cell phone

Primary outcomes:
measure: Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
timeFrame: Up to receipt of second dose, an average of 6 months
Secondary outcomes:
measure: Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
timeFrame: Up to 42 days after first dose
Other outcomes:
Locations:
city: Itasca
country: United States
facility: American Academy of Pediatrics
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Alex Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.