Influenza
Conditions
Keywords
Influenza, text message, vaccination
Brief summary
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Nevertheless, targeting and mobilizing these populations has been difficult and influenza immunization rates nationwide remain low. Immunization reminder-recalls have been shown to be effective, but have had limited ability to rapidly identify and reach large target populations in a cost-effective manner. Evidence on how to optimally design these systems is not yet available and thus text message immunization alerts have not been widely implemented. The investigators propose to implement and evaluate tailored, targeted influenza text message reminders in urban pediatric and pregnant populations.
Interventions
OTHERText Message
Text message vaccine reminders
OTHERautomated call
Automated call
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 50 Years
Healthy volunteers
No
Inclusion criteria
Parents (2010-2011 and 2011-2012 influenza seasons) * Children aged 6 months to 18 years at the beginning of current influenza season * Children with one previous visit at participating pediatric community health center in last year * Parent with cell phone number in registry Pregnant women Pilot (2010-2011 influenza seasons) * Pregnant women who will be in their 2nd or 3rd trimester during the influenza season * Own a cell phone with text message capability Randomized controlled Trial (2011-2012 influenza seasons) * Pregnant and will be in their 2nd or 3rd trimester during the influenza season * Cell phone number in registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Immunization: Pediatric | March 31, 2011 | percentage of pediatric participants with influenza immunization by March 31 of 2011 |
| Influenza Immunization: Pregnant Women | by December 31, 2011 | percentage of pregnant participants with influenza immunization by December 31, 2011 |
| Influenza Immunization: Delayed Pediatric | March 31, 2012 | percentage of pediatric participants with influenza immunization by March 31 of 2012 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric: Vaccinated at Influenza Clinic | March 31, 2011 | percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011 |
| Attendance at Appointment | September-December 2011 | percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011 |
Countries
United States
Participant flow
Recruitment details
Children and pregnant women receiving care at 4 community-based clinics in the United States during the 2010-2011, 2011-2012 influenza season
Pre-assignment details
Children previously vaccinated for influenza before the season of interest were excluded from primary analysis
Participants by arm
| Arm | Count |
|---|---|
| Text Message Vaccine Reminders/Automated Telephone Call Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic | 4,607 |
| Automated Phone Call From Clinic Only Receipt of automated phone call from clinic | 4,606 |
| Pregnant Women: Text Message | 593 |
| Pregnant Women: Usual Care | 594 |
| Delayed Pediatrics: Interactive Text Message | 1,821 |
| Delayed Pediatrics: Conventional Text Message | 1,821 |
| Delayed Pediatrics: Usual Care | 1,820 |
| Total | 15,862 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | < 14 weeks gestational age | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Already received influenza vaccination | 817 | 822 | 13 | 15 | 41 | 61 | 56 | 0 |
| Overall Study | Duplicate patient | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Text Message Vaccine Reminders/Automated Telephone Call | Automated Phone Call From Clinic Only | Pregnant Women: Text Message | Pregnant Women: Usual Care | Delayed Pediatrics: Interactive Text Message | Delayed Pediatrics: Conventional Text Message | Delayed Pediatrics: Usual Care | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 4607 Participants | 4606 Participants | 0 Participants | 0 Participants | 1821 Participants | 1821 Participants | 1820 Participants | 14675 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 593 Participants | 594 Participants | 0 Participants | 0 Participants | 0 Participants | 1187 Participants |
| Region of Enrollment United States | 4607 participants | 4606 participants | 593 participants | 594 participants | 1821 participants | 1821 participants | 1820 participants | 15862 participants |
| Sex: Female, Male Female | 2335 Participants | 2332 Participants | 593 Participants | 594 Participants | 869 Participants | 926 Participants | 862 Participants | 8511 Participants |
| Sex: Female, Male Male | 2272 Participants | 2274 Participants | 0 Participants | 0 Participants | 952 Participants | 895 Participants | 958 Participants | 7351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4,607 | 0 / 4,606 | 0 / 593 | 0 / 594 | 0 / 1,821 | 0 / 1,821 | 0 / 1,820 |
Outcome results
Primary
Influenza Immunization: Delayed Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2012
Time frame: March 31, 2012
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Influenza Immunization: Delayed Pediatric | 38.5 %participants vaccinated with influenza |
| Pediatric: Automated Phone Call From Clinic Only | Influenza Immunization: Delayed Pediatric | 35.3 %participants vaccinated with influenza |
| Delayed Pediatric: Usual Care | Influenza Immunization: Delayed Pediatric | 34.8 %participants vaccinated with influenza |
Primary
Influenza Immunization: Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2011
Time frame: March 31, 2011
Population: Individuals unvaccinated by time intervention start for their cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Influenza Immunization: Pediatric | 43.6 % participant vaccinated with influenza |
| Pediatric: Automated Phone Call From Clinic Only | Influenza Immunization: Pediatric | 39.9 % participant vaccinated with influenza |
Primary
Influenza Immunization: Pregnant Women
percentage of pregnant participants with influenza immunization by December 31, 2011
Time frame: by December 31, 2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Influenza Immunization: Pregnant Women | 49.3 %participants vaccinated with influenza |
| Pediatric: Automated Phone Call From Clinic Only | Influenza Immunization: Pregnant Women | 46.6 %participants vaccinated with influenza |
Secondary
Attendance at Appointment
percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011
Time frame: September-December 2011
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Attendance at Appointment | 85.0 % participants attending appointment |
| Pediatric: Automated Phone Call From Clinic Only | Attendance at Appointment | 87.6 % participants attending appointment |
Secondary
Pediatric: Vaccinated at Influenza Clinic
percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
Time frame: March 31, 2011
Population: those unvaccinated by the start date for their cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Pediatric: Vaccinated at Influenza Clinic | 6.1 % participant vaccinated at flu clinic |
| Pediatric: Automated Phone Call From Clinic Only | Pediatric: Vaccinated at Influenza Clinic | 2.8 % participant vaccinated at flu clinic |