Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 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 seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates

NCT02761551

Reminder Systems Influenza Vaccines

COMPLETED NA

Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado

NCT03246100

Reminder Systems Influenza Vaccines

COMPLETED NA

Centralized Reminder Recall - Flu RCT2

NCT03294473

Influenza, Human Orthomyxoviridae Infections RNA Virus Infections +5 more

COMPLETED NA

Pediatric Second Influenza Dose Portal Reminder Recall

NCT04668417

Influenza Respiratory Tract Infections

COMPLETED NA

Patient Portal - Flu Reminder Recall

NCT03666026

Influenza Respiratory Tract Infections Vaccines

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. Children experience significant morbidity from influenza and also 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 2-17y 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. The published literature suggests R/R can improve influenza vaccination rates. However, few 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 vaccinations. They have not yet been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based reminder/recall. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine reminder/recall, 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 reminder/recall systems. The investigators will also develop tools to aid other states in creating efficient IIS reminder/recall systems for seasonal and possible pandemic influenza outbreaks.

The 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 reminder/recall of different intensity (1 v.2 v. 3 messages) and usual care (0 messages) and 2) effectiveness and cost-effectiveness of reminder/recall 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 reminder/recall for autodialer failures vs. autodialer-alone reminder/recall on influenza vaccination rates using a 2-arm randomized controlled trial.

Aim 4 (dissemination aim) will develop a toolkit for state IIS-based influenza vaccine reminder/recall 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reminder System for Influenza Vaccines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No intervention: Usual Care

Patients in this group will not receive any influenza vaccine reminder notifications.

Group Type NO_INTERVENTION

No interventions assigned to this group

1 Notice

Patients in this group will receive one influenza vaccine reminder notification via autodialer across the 2016 influenza season.

Group Type EXPERIMENTAL

1 Notice

Intervention Type BEHAVIORAL

1 Reminder notification via autodialer

2 Notices

Patients in this group will receive up to two influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.

Group Type EXPERIMENTAL

2 Notices

Intervention Type BEHAVIORAL

2 Reminder notifications via autodialer

3 Notices

Patients in this group will receive up to three influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.

Group Type EXPERIMENTAL

3 Notices

Intervention Type BEHAVIORAL

3 Reminder notifications via autodialer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1 Notice

1 Reminder notification via autodialer

Intervention Type BEHAVIORAL

2 Notices

2 Reminder notifications via autodialer

Intervention Type BEHAVIORAL

3 Notices

3 Reminder notifications via autodialer

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

reminders, notifications

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A record in the New York State Immunization Information System
* In need of at least one influenza vaccination at time of study
* Affiliated with a participating practice