Centralized Reminder Recall - Flu RCT2

Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State

This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted.

Despite U.S. guidelines for influenza vaccination of all children starting at 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 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).

Study Overview

• Status: Completed
• Conditions: RNA Virus Infections; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections; Respiratory Tract Disease; Virus Disease; Physiological Effects of Drugs; Vaccines
• Intervention / Treatment: Behavioral: R/R - Autodialers; Behavioral: R/R - Texting; Behavioral: R/R - mailed postcard

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. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive morbidity among children who 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 2-17years 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. We and others have shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of 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 childhood vaccinations, but they have not been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and mail R/R) 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.

For this second R/R trial in New York State, the intent is to evaluate the impact of reminder recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard of care control group, specifically in relation to raising influenza vaccination rates among children 6m-17 years of age.

The proposed design of this 4-arm RCT:

1. standard of care control
2. autodialer R/R -- with brief educational messages, practice name and practice phone number
3. text message R/R-- with brief educational messages, practice name and practice phone number
4. mailed (postcards) R/R-- with brief educational messages, practice name and practice phone number

Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care

Hypothesis 2: Text messaging will be more cost-effective than other modalities

• Study Type: Interventional
• Enrollment (Actual): 70190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• a record in the New York State Immunization Information System
• in need of at least one influenza vaccination at the time of the beginning of the study
• affiliated with a participating practice (145 randomly selected)

Exclusion Criteria:

• no record within the New York State Immunization Information System
• up to date on their influenza vaccination
• not affiliated with an eligible practice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autodial R/R; R/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number	Behavioral: R/R - Autodialers; Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
Experimental: Text Message R/R; R/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number	Behavioral: R/R - Texting; Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
Experimental: Postcard R/R; R/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number	Behavioral: R/R - mailed postcard; Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
No Intervention: Standard of Care Control; Participants in this group will not receive any influenza vaccination reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R	Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of the R/R intervention	A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.	6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Colorado, Denver; National Institute of Allergy and Infectious Diseases (NIAID); New York State Department of Health
• Investigators: Principal Investigator: Peter Szilagyi, MD, MPH, University of California, Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): April 19, 2018
• Study Completion (Actual): May 4, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: reminder recall (R/R), influenza vaccines
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections
• Other Study ID Numbers: 17-001153 (Other Identifier: University of California, Los Angeles, IRB); 1R01AI114903 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate results will be prepared for publication at the end of the trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No