Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Influenza, Vaccines |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 1/31/2019 |
| Start Date: | September 6, 2017 |
| End Date: | April 30, 2019 |
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado
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.
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.
Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S.
with high rates of hospitalizations, emergency department and outpatient visits, and medical
costs. Children experience significant morbidity from influenza, and also play a critical
role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization
Practices (ACIP) has recommended influenza vaccination for all children >6 months of age.
However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated.
Low rates are a concern for both seasonal influenza and in preparation for pandemic
influenza. One of the nationally recommended strategies for raising childhood influenza
vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise
rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R
despite many studies showing its effectiveness.
Statewide immunization information systems (IISs) now exist in all states to track childhood
vaccinations, but they have not been used for R/R for influenza vaccine because of the lack
of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators
have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess
the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two
types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop
tools to aid other states in creating efficient IIS R/R systems for seasonal and possible
pandemic influenza outbreaks.
In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus
standard-of-care control on raising influenza vaccination rates among children 6m-17 years of
age.
The investigators propose a 3-arm RCT study design with the following study arms:
1. Standard of care control
2. Autodialer (3 reminders)- with brief education message + practice name + practice phone
#
3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice
phone #
with high rates of hospitalizations, emergency department and outpatient visits, and medical
costs. Children experience significant morbidity from influenza, and also play a critical
role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization
Practices (ACIP) has recommended influenza vaccination for all children >6 months of age.
However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated.
Low rates are a concern for both seasonal influenza and in preparation for pandemic
influenza. One of the nationally recommended strategies for raising childhood influenza
vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise
rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R
despite many studies showing its effectiveness.
Statewide immunization information systems (IISs) now exist in all states to track childhood
vaccinations, but they have not been used for R/R for influenza vaccine because of the lack
of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators
have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess
the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two
types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop
tools to aid other states in creating efficient IIS R/R systems for seasonal and possible
pandemic influenza outbreaks.
In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus
standard-of-care control on raising influenza vaccination rates among children 6m-17 years of
age.
The investigators propose a 3-arm RCT study design with the following study arms:
1. Standard of care control
2. Autodialer (3 reminders)- with brief education message + practice name + practice phone
#
3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice
phone #
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
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