Clinical trial NCT01390363: Study of Adolescent Immunization Recall Systems
Official title: Adolescent Immunization Recall Systems: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Reminder Systems
Keywords: immunization
reminder systems
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 420
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: receipt of vaccine of interest at 28 days
timeFrame: 28 days
Secondary outcomes:
measure: receipt of vaccine of interest at 1 year
timeFrame: 1 year
measure: receipt of other vaccines at 28 days
timeFrame: 28 days
measure: receipt of other vaccines at 1 year
timeFrame: 1 year
measure: receipt of prior vaccines at 28 days
timeFrame: 28 days
measure: receipt of prior vaccines at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Kathryn S Brigham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brigham KS, Woods ER, Steltz SK, Sandora TJ, Blood EA. Randomized controlled trial of an immunization recall intervention for adolescents. Pediatrics. 2012 Sep;130(3):507-14. doi: 10.1542/peds.2012-0471. Epub 2012 Aug 20.