Influenza, Vaccination
Conditions
Keywords
text message, Short message service (SMS), mHealth
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).
Interventions
BEHAVIORALText message influenza vaccine reminders
Text message reminders for second dose of influenza vaccination
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American Academy of Pediatrics
Children's Hospital of Philadelphia
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The care provider, primary statistician and analyst will be blinded to participant status.
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year | Up to receipt of second dose, an average of 6 months | Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination | Up to 42 days after first dose | Receipt of second dose influenza vaccine by 42 days after first dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination | 1,044 |
| Usual Care 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. | 1,042 |
| Total | 2,086 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not meeting inclusion criteria | 5 | 12 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Customized 2-8 years | 78 Participants | 77 Participants | 155 Participants |
| Age, Customized age 6-23 month | 966 Participants | 965 Participants | 1931 Participants |
| Preferred Language for Texting English | 966 Participants | 964 Participants | 1930 Participants |
| Preferred Language for Texting Spanish | 78 Participants | 78 Participants | 156 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 521 Participants | 492 Participants | 1013 Participants |
| Sex: Female, Male Male | 523 Participants | 550 Participants | 1073 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,044 | 0 / 1,042 |
| other Total, other adverse events | 0 / 1,044 | 0 / 1,042 |
| serious Total, serious adverse events | 0 / 1,044 | 0 / 1,042 |
Outcome results
Primary
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
Time frame: Up to receipt of second dose, an average of 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year | 875 Participants |
| Usual Care | Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year | 843 Participants |
Secondary
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
Time frame: Up to 42 days after first dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination | 651 Participants |
| Usual Care | Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination | 580 Participants |