Respiratory Tract Infections Clinical Trial
Official title:
Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State
Verified date | June 2019 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some
modifications in relation to the intervention arms as well as the use of a different cohort,
thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in
New York State, through partnership with the New York State Health Department (excluding New
York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this
was decided as some of the intervention components are different enough that separate
registrations were warranted.
Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only
about half of children are vaccinated annually leading to substantial influenza disease in
children and spread of disease to adults. A major barrier is that families are not reminded
about the need for their children to receive influenza vaccination. The investigators will
evaluate the impact of patient reminder/recall (R/R) performed by state immunization
information systems to improve influenza vaccination rates by using 4 clinical trials (2 per
state) in two different states. The investigators will assess effectiveness and
cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as
compared to 4) standard of care control (no R/R).
Status | Completed |
Enrollment | 70190 |
Est. completion date | May 4, 2018 |
Est. primary completion date | April 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 17 Years |
Eligibility |
Inclusion Criteria: - a record in the New York State Immunization Information System - in need of at least one influenza vaccination at the time of the beginning of the study - affiliated with a participating practice (145 randomly selected) Exclusion Criteria: - no record within the New York State Immunization Information System - up to date on their influenza vaccination - not affiliated with an eligible practice |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute of Allergy and Infectious Diseases (NIAID), New York State Department of Health, University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R | Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data. | 6 months | |
Secondary | Cost of the R/R intervention | A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards. | 6 months |
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