Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02761551
Study type Interventional
Source University of Colorado, Denver
Contact
Status Completed
Phase N/A
Start date September 1, 2016
Completion date April 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT03246100 - Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado N/A
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Recruiting NCT05298800 - Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23 Phase 4
Completed NCT03735147 - Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children Phase 4
Completed NCT02831608 - Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis Phase 4
Completed NCT02560909 - Adjuvanted Influenza Vaccine in Stem Cell Transplant Phase 4
Withdrawn NCT01623232 - MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly Phase 1/Phase 2
Completed NCT00961337 - Evaluation of a School-based Influenza Vaccination Program Phase 4
Completed NCT00402805 - Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy Phase 4
Completed NCT00222638 - Influenza Vaccination and Oral Anticoagulant Therapy Phase 4
Active, not recruiting NCT03734237 - A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD Phase 4
Completed NCT01013675 - Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly Phase 2
Completed NCT00306995 - Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population Phase 2
Completed NCT01310413 - Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age Phase 3
Completed NCT00449670 - Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Phase 3
Completed NCT01788228 - Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure Phase 3
Completed NCT00296270 - Memory for Flu Facts and Myths and Effects on Vaccine Intentions N/A
Recruiting NCT05521763 - Influenza Vaccine Uptake Among Healthcare Workers N/A
Completed NCT00718120 - Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years Phase 3
Completed NCT00430521 - Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A) Phase 2