Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado
Condition: Reminder Systems; Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 #
    

Intervention name(s): Reminders
Intervention type(s): Behavioral
Intervention description(s): Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized within practices to one of 3 arms:
Standard of care control
Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts)
Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: centralized reminder/recall; influenza vaccine reminders; childhood influenza vaccines