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

NCT03246100 | Completed

• 1 other identifier: 15-0570_2
• Study Type: interventional
• Target: 25,531
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission. 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: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) 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.

Conditions

Reminder Systems; Influenza Vaccines

Keywords

centralized reminder/recall; influenza vaccine reminders; childhood influenza vaccines

Outcome Measures

Primary Outcomes (1)

• Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state

  Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.

  6 months

Study Arms (3)

Control

NO INTERVENTION

These patients will receive no reminders from the health department and will receive usual care.

Autodialer R/R

EXPERIMENTAL

Autodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone #

Behavioral: Reminders

Mail R/R

EXPERIMENTAL

Mailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone #

Behavioral: Reminders

Interventions

Reminders BEHAVIORAL

Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.

Autodialer R/R; Mail R/R

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have record in Colorado Immunization Information System
• from 6 months through 17 years of age
• have not received an influenza vaccine by start of trial
• must be affiliated with one of our 42 randomly selected primary care practices in Colorado

You may not qualify if:

• those without a record
• received an influenza vaccine post 9/1/2017
• not affiliated with an eligible study

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.

  PMID: 32446470 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory 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

Model Details: Patients will be randomized within practices to one of 3 arms: 1. Standard of care control 2. Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts) 3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 11, 2017
• Study Start: September 6, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)