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Study of Adolescent Immunization Recall Systems

Adolescent Immunization Recall Systems: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01390363
Enrollment
420
Registered
2011-07-11
Start date
2010-05-01
Completion date
2011-07-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization, Reminder Systems

Keywords

immunization, reminder systems

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.

Interventions

OTHERParent 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.

OTHERParent 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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
receipt of vaccine of interest at 28 days28 daysVaccination records are assessed 28 days after the intervention to see if Tdap, MCV4, or the 2nd VZV vaccine were administered.

Secondary

MeasureTime frameDescription
receipt of vaccine of interest at 1 year1 yearImmunization records are assessed 1 year after the intervention to assess for receipt of Tdap, MCV4, and/or the 2nd VZV vaccine.
receipt of other vaccines at 28 days28 daysImmunization records are assessed 28 days after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.
receipt of other vaccines at 1 year1 yearImmunization records are assessed 1 year after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.
receipt of prior vaccines at 28 days28 daysWe will assess the immunization record at 28 days to see if it has been updated with vaccines given prior to the enrollment date to see if we successfully obtained copies of immunization records at other healthcare sites.
receipt of prior vaccines at 1 year1 yearWe will assess the immunization record at 1 year to see if it has been updated with vaccines given prior to the enrollment date to see if we successfully obtained copies of immunization records at other healthcare sites.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026