Overview

This trial is active, not recruiting.

Conditions immunization, reminder systems
Treatments parent only phone call, parent and adolescent phone call
Sponsor Children's Hospital Boston
Start date May 2010
End date July 2011
Trial size 420 participants
Trial identifier NCT01390363, 10-01-0025

Summary

The purpose of this study is to determine whether contacting the parents of adolescents overdue for routine vaccines or contacting both the parents AND adolescents overdue to routine vaccines improves immunization rates as compared to usual care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
This study arm will receive usual clinical care, but no specific intervention will be made to inform the parent or adolescent that the adolescents is overdue for a routine vaccine.
(Experimental)
Parent Only Phone Call
parent only phone call
A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites.
(Experimental)
Parent and Adolescent Phone Call
parent and adolescent phone call
A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites. We will also ask permission to speak with the adolescent as well, and if granted, will make up to 4 phone calls to the adolescent to convey the same message.

Primary Outcomes

Measure
receipt of vaccine of interest at 28 days
time frame: 28 days

Secondary Outcomes

Measure
receipt of vaccine of interest at 1 year
time frame: 1 year
receipt of other vaccines at 28 days
time frame: 28 days
receipt of other vaccines at 1 year
time frame: 1 year
receipt of prior vaccines at 28 days
time frame: 28 days
receipt of prior vaccines at 1 year
time frame: 1 year

Eligibility Criteria

Female participants from 13 years up to 17 years old.

Inclusion Criteria: - at least 13 years of age and under 18 years of age - had a billing code for an annual physical exam in the past 3 years at the Adolescent/Young Adult Medical Practice at Children's Hospital Boston - immunization record shows one of the following: no tetanus containing vaccine in the previous 5 years; no MCV4 vaccine; and/or has received the 1st VZV vaccine but not the 2nd VZV vaccine and has no documented history of the chicken pox Exclusion Criteria: - immunization record shows no vaccines or only influenza vaccines - sibling enrolled in the study - in the custody of the Department of Youth Services - in the custody of the Department of Child and Family Services

Additional Information

Official title Adolescent Immunization Recall Systems: A Randomized Controlled Trial
Principal investigator Kathryn S Brigham, MD
Description This randomized controlled trial is a 3-armed study designed to evaluate an immunization recall system in adolescents. In the control arm (Group 1), the adolescents will receive usual care, in which they will primarily receive immunizations at annual physical exams, or as recommended by providers at urgent care visits. In one intervention arm (Group 2), the parent/guardian will receive a telephone call informing them that the adolescent is overdue for one or more immunizations (conjugated Neisseria meningitidis (MCV4) vaccine, tetanus-diphtheria-pertussis (Tdap) booster, and/or the second varicella (VZV) vaccine). In the second intervention arm (Group 3), both the parent/guardian and the adolescent will receive a telephone call informing them that the adolescent is overdue for one or more immunizations. Immunization rates will be compared between the 3 groups at a four week and a twelve month follow up period.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.