Centralized Reminder Recall - Flu RCT2
Condition: Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Disease; Respiratory Tract Infections; Respiratory Tract Disease; Vaccines; Physiological Effects of Drugs
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some
      modifications in relation to the intervention arms as well as the use of a different cohort,
      thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in
      New York State, through partnership with the New York State Health Department (excluding New
      York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this
      was decided as some of the intervention components are different enough that separate
      registrations were warranted.

      Despite U.S. guidelines for influenza vaccination of all children starting at 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 4 clinical trials (2 per
      state) in two different states. The investigators will assess effectiveness and
      cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as
      compared to 4) standard of care control (no R/R).
    

Detailed description: 
      Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US
      with high rates of hospitalizations, emergency department visits, outpatient visits, and
      medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive
      morbidity among children who play a key role in instigating and expanding epidemics. In
      addition, concerns about pandemic influenza heighten the importance of new mechanisms to
      rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.

      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.
      For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies
      suggest that as many as 19 million cases of influenza could be prevented if child vaccination
      rates were raised to 70% nationally.

      The most effective strategy recommended by CDC and the Task Force on Community Preventive
      Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent
      by phone or mail, notifying parents of the need to vaccinate their child. We and others have
      shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of
      practices use R/R; barriers are practice costs, insufficient staff time and expertise, and
      lack of predictability regarding receipt of vaccine supplies.

      Statewide immunization information systems (IISs) now exist in all states to track childhood
      vaccinations, but they have not been used for influenza vaccine R/R because of lack of
      evidence for their effectiveness and a lack of a template for IIS-based R/R. The
      investigators have united two leading immunization research groups (Denver, CO and Rochester
      (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza
      vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and
      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.

      For this second R/R trial in New York State, the intent is to evaluate the impact of reminder
      recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard
      of care control group, specifically in relation to raising influenza vaccination rates among
      children 6m-17 years of age.

      The proposed design of this 4-arm RCT:

        1. standard of care control

        2. autodialer R/R -- with brief educational messages, practice name and practice phone
           number

        3. text message R/R-- with brief educational messages, practice name and practice phone
           number

        4. mailed (postcards) R/R-- with brief educational messages, practice name and practice
           phone number

      Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care

      Hypothesis 2: Text messaging will be more cost-effective than other modalities
    

Intervention name(s): R/R - Autodialers; R/R - Texting; R/R - mailed postcard
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).; Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).; Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: reminder recall (R/R), influenza vaccines