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Clinical Trials/NCT01390363
NCT01390363
Completed
Not Applicable

Adolescent Immunization Recall Systems: A Randomized Controlled Trial

Boston Children's Hospital1 site in 1 country420 target enrollmentMay 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immunization
Sponsor
Boston Children's Hospital
Enrollment
420
Locations
1
Primary Endpoint
receipt of vaccine of interest at 28 days
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2010
End Date
July 31, 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathryn S. Brigham

Fellow

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

receipt of vaccine of interest at 28 days

Time Frame: 28 days

Vaccination records are assessed 28 days after the intervention to see if Tdap, MCV4, or the 2nd VZV vaccine were administered.

Secondary Outcomes

  • receipt of vaccine of interest at 1 year(1 year)
  • receipt of other vaccines at 28 days(28 days)
  • receipt of other vaccines at 1 year(1 year)
  • receipt of prior vaccines at 28 days(28 days)
  • receipt of prior vaccines at 1 year(1 year)

Study Sites (1)

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