University of California, Los Angeles
Los Angeles, California, 90095, United States
NCT Number: NCT03294473
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).
Looking for future studies?
Notify Me6 month–17 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 6 months
Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.
Time frame: 6 months
A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.
University of California, Los Angeles
Other
Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03392207
Infections, Influenza, Human
São Paulo, Brazil
View Trial DetailsNCT05422326
Animal Diseases, Bird Diseases
Huntsville, Alabama, United States
View Trial DetailsNCT01587131
Infections, Influenza, Human
Winnipeg, Manitoba, Canada
View Trial DetailsNCT03283319
Animal Diseases, Bird Diseases
Lenexa, Kansas, United States
View Trial Details