search
Back to results

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

Primary Purpose

Reminder System for Influenza Vaccines

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1 Notice
2 Notices
3 Notices
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Reminder System for Influenza Vaccines focused on measuring reminder systems, Influenza vaccines

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Up to date on influenza vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    No intervention: Usual Care

    1 Notice

    2 Notices

    3 Notices

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Number of subjects receiving influenza vaccine
    The primary outcome is receipt of influenza vaccine by children receiving zero notices compared to those receiving 1,2, or 3 notices.

    Secondary Outcome Measures

    Number of subjects receiving influenza vaccine based on demographic subgroups
    This outcome will categorize the number of influenza vaccines administered by subgroups, e.g. Urban/rural, Pediatrics/Family Practice, and age from 6 months-1.9 years, 2-10.9 years and 11-17.9 years.
    Number of subjects <9 years of age that will receive an additional vaccine

    Full Information

    First Posted
    September 23, 2016
    Last Updated
    April 24, 2020
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02924467
    Brief Title
    Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State
    Official Title
    Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates in New York State
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    May 2, 2017 (Actual)
    Study Completion Date
    May 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.
    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reminder System for Influenza Vaccines
    Keywords
    reminder systems, Influenza vaccines

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No intervention: Usual Care
    Arm Type
    No Intervention
    Arm Description
    Patients in this group will not receive any influenza vaccine reminder notifications.
    Arm Title
    1 Notice
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive one influenza vaccine reminder notification via autodialer across the 2016 influenza season.
    Arm Title
    2 Notices
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive up to two influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.
    Arm Title
    3 Notices
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive up to three influenza vaccine reminder notifications via autodialer throughout the 2016 influenza season.
    Intervention Type
    Behavioral
    Intervention Name(s)
    1 Notice
    Other Intervention Name(s)
    reminders, notifications
    Intervention Description
    1 Reminder notification via autodialer
    Intervention Type
    Behavioral
    Intervention Name(s)
    2 Notices
    Intervention Description
    2 Reminder notifications via autodialer
    Intervention Type
    Behavioral
    Intervention Name(s)
    3 Notices
    Intervention Description
    3 Reminder notifications via autodialer
    Primary Outcome Measure Information:
    Title
    Number of subjects receiving influenza vaccine
    Description
    The primary outcome is receipt of influenza vaccine by children receiving zero notices compared to those receiving 1,2, or 3 notices.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of subjects receiving influenza vaccine based on demographic subgroups
    Description
    This outcome will categorize the number of influenza vaccines administered by subgroups, e.g. Urban/rural, Pediatrics/Family Practice, and age from 6 months-1.9 years, 2-10.9 years and 11-17.9 years.
    Time Frame
    6 months
    Title
    Number of subjects <9 years of age that will receive an additional vaccine
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Exclusion Criteria: Up to date on influenza vaccine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allison Kempe, MD, MPH
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23237154
    Citation
    Kempe A, Saville A, Dickinson LM, Eisert S, Reynolds J, Herrero D, Beaty B, Albright K, Dibert E, Koehler V, Lockhart S, Calonge N. Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial. Am J Public Health. 2013 Jun;103(6):1116-23. doi: 10.2105/AJPH.2012.301035. Epub 2012 Dec 13.
    Results Reference
    background
    PubMed Identifier
    25706340
    Citation
    Kempe A, Saville AW, Dickinson LM, Beaty B, Eisert S, Gurfinkel D, Brewer S, Shull H, Herrero D, Herlihy R. Collaborative centralized reminder/recall notification to increase immunization rates among young children: a comparative effectiveness trial. JAMA Pediatr. 2015 Apr;169(4):365-73. doi: 10.1001/jamapediatrics.2014.3670.
    Results Reference
    background
    PubMed Identifier
    31698085
    Citation
    Kempe A, Saville AW, Albertin C, Helmkamp L, Zhou X, Vangela S, Dickinson LM, Tseng CH, Campbell JD, Whittington M, Gurfinkel D, Roth H, Hoefer D, Szilagyi P. Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial. Acad Pediatr. 2020 Apr;20(3):374-383. doi: 10.1016/j.acap.2019.10.015. Epub 2019 Nov 5.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs