NCT02761551

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56,549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

April 27, 2016

Last Update Submit

June 20, 2019

Conditions

Reminder SystemsInfluenza Vaccines

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (2)

  • Number of subjects receiving influenza vaccine based on demographic subgroups.

    6 months

  • Number of subjects <9 years of age that will receive an additional vaccine.

    1 month

Study Arms (4)

Usual Care

NO INTERVENTION

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

1 notice

EXPERIMENTAL

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

Behavioral: Reminder notifications via autodialer

2 notices

EXPERIMENTAL

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

Behavioral: Reminder notifications via autodialer

3 notices

EXPERIMENTAL

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

Behavioral: Reminder notifications via autodialer

Interventions

Reminder notifications via autodialerBEHAVIORAL
1 notice2 notices3 notices

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Opted out of participating in CIIS, or
  • Are up-to-date on influenza vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 25706340BACKGROUND

  • 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.

    PMID: 23237154RESULT

  • 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.

    PMID: 31698085DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Allison Kempe, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 4, 2016

Study Start

September 1, 2016

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

June 24, 2019

Record last verified: 2019-06