Reminder Systems Clinical Trial
Official title:
State Immunization Information Systems to Improve HPV Vaccination Rates
Verified date | April 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17.
Status | Completed |
Enrollment | 30616 |
Est. completion date | January 17, 2019 |
Est. primary completion date | January 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 11 through 17 years of age - patient of a participating practice (practices randomly selected) - is either due for an HPV dose at baseline, or - has initiated but not yet completed the HPV series at baseline Exclusion Criteria: - has completed the HPV vaccination series |
Country | Name | City | State |
---|---|---|---|
United States | University of California LA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Cancer Institute (NCI), University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry) | Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via electronic medical record (EMR) direct transfer or manual entry. | 5 months from initial recall notices for the first dose | |
Primary | Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry) | Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the first recall notice of the last dose (could be dose 2 or dose 3, depending on the age at which they received their first dose) for adolescents to complete their vaccination series. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. | 5 months from first reminder received for last dose | |
Secondary | Differences between arms - initiation | Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. We will compare the arms (receipt of zero, 1, 2 or 3 reminders) to see if there are any differences between the arms in terms of receipt of the 1st dose of HPV vaccine | 5 months | |
Secondary | Differences between arms - completion | Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. | 20 months |
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