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
About this trial
This is an interventional health services research trial for Reminder Systems
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
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
NCT ID
NCT02761551
First Posted
April 27, 2016
Last Updated
June 20, 2019
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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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