Study of Adolescent Immunization Recall Systems

Immunization Clinical Trial

Official title:

Adolescent Immunization Recall Systems: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390363
• Other study ID #: 10-01-0025
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: April 12, 2017
• Start date: May 1, 2010
• Est. completion date: July 31, 2011

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 31, 2011
• Est. primary completion date: July 31, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunization
• Reminder Systems

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	receipt of vaccine of interest at 28 days	Vaccination records are assessed 28 days after the intervention to see if Tdap, MCV4, or the 2nd VZV vaccine were administered.	28 days
Secondary	receipt of vaccine of interest at 1 year	Immunization records are assessed 1 year after the intervention to assess for receipt of Tdap, MCV4, and/or the 2nd VZV vaccine.	1 year
Secondary	receipt of other vaccines at 28 days	Immunization records are assessed 28 days after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.	28 days
Secondary	receipt of other vaccines at 1 year	Immunization records are assessed 1 year after the intervention to assess for receipt of any vaccine other than Tdap, MCV4, and the 2nd VZV.	1 year
Secondary	receipt of prior vaccines at 28 days	We 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.	28 days
Secondary	receipt of prior vaccines at 1 year	We 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.	1 year