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| ID | Type | Description | Link |
|---|---|---|---|
| R40MC17169-01 | Other Grant/Funding Number | R40MC17169-01 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message vaccine reminders | Experimental | Receipt of text message vaccine reminders |
|
| automated phone call from clinic | Active Comparator | Receipt of automated phone call from clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Other | Text message vaccine reminders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Influenza Immunization: Pediatric | percentage of pediatric participants with influenza immunization by March 31 of 2011 | March 31, 2011 |
| Influenza Immunization: Pregnant Women | percentage of pregnant participants with influenza immunization by December 31, 2011 | by December 31, 2011 |
| Influenza Immunization: Delayed Pediatric | percentage of pediatric participants with influenza immunization by March 31 of 2012 | March 31, 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric: Vaccinated at Influenza Clinic | percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011 | March 31, 2011 |
| Attendance at Appointment | percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011 |
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Inclusion criteria Parents (2010-2011 and 2011-2012 influenza seasons)
Pregnant women Pilot (2010-2011 influenza seasons)
Randomized controlled Trial (2011-2012 influenza seasons)
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| Name | Affiliation | Role |
|---|---|---|
| Melissa S Stockwell, MD MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24354839 | Derived | Stockwell MS, Westhoff C, Kharbanda EO, Vargas CY, Camargo S, Vawdrey DK, Castano PM. Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):e7-12. doi: 10.2105/AJPH.2013.301620. Epub 2013 Dec 19. | |
| 22535855 | Derived |
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Children previously vaccinated for influenza before the season of interest were excluded from primary analysis
Children and pregnant women receiving care at 4 community-based clinics in the United States during the 2010-2011, 2011-2012 influenza season
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Text Message Vaccine Reminders/Automated Phone Call | Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic |
| FG001 | Pediatric: Automated Phone Call From Clinic Only | Receipt of automated phone call from clinic |
| FG002 | Pregnant Women: Text Message | Received text message reminders |
| FG003 | Pregnant Women: Usual Care | Received usual care |
| FG004 | Delayed Pediatrics: Interactive Text Message Vaccine Reminders | Vaccination of children not yet vaccinated by mid-November: interactive message |
| FG005 | Delayed Pediatric: Conventional Text Message | Vaccination of children not yet vaccinated by mid-November: conventional text message |
| FG006 | Delayed Pediatric: Usual Care | Vaccination of children not yet vaccinated by mid-November: usual care |
| FG007 | Parents | Included in enrollment but not in outcomes which are on child level |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Automated Phone Call From Clinic Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Influenza Immunization: Pediatric | percentage of pediatric participants with influenza immunization by March 31 of 2011 | Individuals unvaccinated by time intervention start for their cohort | Posted | Number | % participant vaccinated with influenza | March 31, 2011 |
|
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Only Serious Adverse Events were collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric: Text Message Vaccine-reminders/Automated Phone Call | Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Stockwell, MD MPH | Columbia University | 212-342-5372 | mss2112@columbia.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D006296 | Health Services |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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| automated call | Other | Automated call |
|
|
| September-December 2011 |
| Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502. |
| < 14 weeks gestational age |
|
| Duplicate patient |
|
Receipt of automated phone call from clinic
| BG002 | Pregnant Women: Text Message |
| BG003 | Pregnant Women: Usual Care |
| BG004 | Delayed Pediatrics: Interactive Text Message |
| BG005 | Delayed Pediatrics: Conventional Text Message |
| BG006 | Delayed Pediatrics: Usual Care |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pediatric: Vaccinated at Influenza Clinic | percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011 | those unvaccinated by the start date for their cohort | Posted | Number | % participant vaccinated at flu clinic | March 31, 2011 |
|
|
|
| Secondary | Attendance at Appointment | percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011 | Posted | Number | % participants attending appointment | September-December 2011 |
|
|
|
| Primary | Influenza Immunization: Pregnant Women | percentage of pregnant participants with influenza immunization by December 31, 2011 | Posted | Number | %participants vaccinated with influenza | by December 31, 2011 |
|
|
|
| Primary | Influenza Immunization: Delayed Pediatric | percentage of pediatric participants with influenza immunization by March 31 of 2012 | Posted | Number | %participants vaccinated with influenza | March 31, 2012 |
|
|
|
| 0 |
| 4,607 |
| 0 |
| 0 |
| EG001 | Pediatric: Automated Phone Call From Clinic Only | Receipt of automated phone call from clinic | 0 | 4,606 | 0 | 0 |
| EG002 | Pregnant Women: Text Message | 0 | 593 | 0 | 0 |
| EG003 | Pregnant Women: Usual Care | 0 | 594 | 0 | 0 |
| EG004 | Delayed Pediatric: Interactive Text Message | 0 | 1,821 | 0 | 0 |
| EG005 | Delayed Pediatric: Conventional Text Message | 0 | 1,821 | 0 | 0 |
| EG006 | Delayed Pediatric: Usual Care | 0 | 1,820 | 0 | 0 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |