Influenza Vaccines Clinical Trial
Official title:
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado
Verified date | June 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are
slight changes to methods and a different cohort will be used, thus justifying a 2nd
ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in
Colorado. Each state has it's own ClinicalTrials.gov submission.
Despite U.S. guidelines for influenza vaccination of all children starting at age 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 three
clinical trials in two states. The investigators will assess effectiveness and
cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall
versus 3) usual care (no R/R) on improving influenza vaccination rates.
The investigators will disseminate the state immunization information system based
reminder/recall system to all states for use for both seasonal and pandemic influenza
vaccinations with the goal of lowering influenza morbidity.
Status | Completed |
Enrollment | 25531 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 17 Years |
Eligibility |
Inclusion Criteria: - have record in Colorado Immunization Information System - from 6 months through 17 years of age - have not received an influenza vaccine by start of trial - must be affiliated with one of our 42 randomly selected primary care practices in Colorado Exclusion Criteria: - those without a record - received an influenza vaccine post 9/1/2017 - not affiliated with an eligible study |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state | Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data. | 6 months |
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