Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine

Study Overview
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Brief Summary
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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
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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).

Official Title
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Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine

Conditions
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Influenza, Vaccination

Intervention / Treatment
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* Behavioral: Text message influenza vaccine reminders


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Text message influenza vaccine reminders | Behavioral: Text message influenza vaccine reminders<br>* Text message reminders for second dose of influenza vaccination<br>|
| No Intervention: Usual care<br>Season 2017-18: Usual care has no text message Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year | Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year | Up to receipt of second dose, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination | Receipt of second dose influenza vaccine by 42 days after first dose | Up to 42 days after first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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text message, Short message service (SMS), mHealth