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

Summary: 
      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 phone reminder/recall 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
      intensity of recall (1 v. 2 v. 3 reminders) 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.

      This study has four aims.

      Aim 1 is to develop the protocols, clinical decision support, and message content for state
      IISs to conduct reminder/recall for influenza vaccinations.

      Aim 2 is to conduct a pragmatic trial, with randomization at the level of the patient within
      practices randomly selected to be proportionate to each state, to compare: 1) effectiveness
      and cost-effectiveness of centralized R/R of different intensity (1 vs. 2 vs. 3 messages) and
      usual care (0 messages) and 2) effectiveness and cost-effectiveness of R/R in specified
      subgroups (family medicine vs pediatric provider, rural vs urban, age of child) on receipt of
      influenza vaccination.

      Aim 3 will measure the effect of adding mailed or text message R/R for autodialer failures
      vs. autodialer-alone R/R on influenza vaccination rates using a 2-arm Randomized Controlled
      Trial (RCT).

      Aim 4 (dissemination aim) will develop a toolkit for state IIS-based influenza vaccine R/R
      for seasonal and pandemic influenza, and work with key stakeholders on a sustainability plan.

      By the end of the study the investigators will have a feasible and cost-effective model to
      raise child seasonal or possibly pandemic influenza vaccination rates to prevent influenza.
      The investigators will disseminate the IIS model to all states.
    

Intervention name(s): Reminder notifications via autodialer
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research