Centralized Reminder Recall - Flu RCT2

NCT03294473 | Completed

• 2 other identifiers: 17-0011531R01AI114903
• Study Type: interventional
• Target: 70,190
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Disease; Respiratory Tract Infections; Respiratory Tract Disease; Vaccines; Physiological Effects of Drugs

Keywords

reminder recall (R/R), influenza vaccines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost of the R/R intervention

  6 months

Study Arms (4)

Autodial R/R

EXPERIMENTAL

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

Text Message R/R

EXPERIMENTAL

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

Postcard R/R

EXPERIMENTAL

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

Standard of Care Control

NO INTERVENTION

Participants in this group will not receive any influenza vaccination reminders

Interventions

R/R - Autodialers BEHAVIORAL

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).

Autodial R/R

R/R - Texting BEHAVIORAL

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).

Text Message R/R

R/R - mailed postcard BEHAVIORAL

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).

Postcard R/R

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• New York State Department of Health: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, 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; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Peter Szilagyi, MD, MPH

  University of California, Los Angeles

  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: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice Chair, Clinical Research, UCLA David Geffen School of Medicine, Dept of Pediatrics

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: October 18, 2017
• Primary Completion: April 19, 2018
• Study Completion: May 4, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)