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

Primary Purpose

Reminder Systems, Influenza Vaccines

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reminder notifications via autodialer
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Reminder Systems

Eligibility Criteria

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

Inclusion Criteria:

  • A record in the Colorado Immunization Information System,
  • In need of at least one influenza vaccination at time of study,
  • Affiliated with a participating practice, or
  • Randomly selected among unaffiliated patients.

Exclusion Criteria:

  • Opted out of participating in CIIS, or
  • Are 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

    Usual Care

    1 notice

    2 notices

    3 notices

    Arm Description

    Patients in this group will not receive any reminders for influenza vaccine.

    Patients in this group will receive one reminder for influenza vaccine across the 2016 influenza season.

    Patients in this group will receive up to two reminders for influenza vaccine across the 2016 season.

    Patients in this group will receive up to three reminders for influenza vaccine across the 2016 season.

    Outcomes

    Primary Outcome Measures

    Number of subjects receiving influenza vaccine based on zero notices versus those receiving 1, 2 or 3 notices.
    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 6m-1.9 yr., 2-10.9 yr. and 11-17.9 yr.
    Number of subjects <9 years of age that will receive an additional vaccine.
    If the subject is <9 years of age, they are required to received a second vaccine at least 1 month after receiving the initial vaccine.

    Full Information

    First Posted
    April 27, 2016
    Last Updated
    June 20, 2019
    Sponsor
    University of Colorado, Denver
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02761551
    Brief Title
    Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates
    Official Title
    Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates: Colorado
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    April 30, 2019 (Actual)
    Study Completion Date
    April 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    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 (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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    56549 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Patients in this group will not receive any reminders for influenza vaccine.
    Arm Title
    1 notice
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive one reminder for influenza vaccine across the 2016 influenza season.
    Arm Title
    2 notices
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive up to two reminders for influenza vaccine across the 2016 season.
    Arm Title
    3 notices
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive up to three reminders for influenza vaccine across the 2016 season.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Reminder notifications via autodialer
    Primary Outcome Measure Information:
    Title
    Number of subjects receiving influenza vaccine based on zero notices versus those receiving 1, 2 or 3 notices.
    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 6m-1.9 yr., 2-10.9 yr. and 11-17.9 yr.
    Time Frame
    6 months
    Title
    Number of subjects <9 years of age that will receive an additional vaccine.
    Description
    If the subject is <9 years of age, they are required to received a second vaccine at least 1 month after receiving the initial 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 Colorado Immunization Information System, In need of at least one influenza vaccination at time of study, Affiliated with a participating practice, or Randomly selected among unaffiliated patients. Exclusion Criteria: Opted out of participating in CIIS, or Are 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

    Citations:
    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
    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
    result
    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

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

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