NCT01390363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2011

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

July 7, 2011

Last Update Submit

April 12, 2017

Conditions

ImmunizationReminder Systems

Keywords

immunizationreminder systems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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 Arms (3)

control

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.

Parent Only Group

EXPERIMENTAL

Parent Only Phone Call

Other: Parent Only Phone Call

Parent and Adolescent Group

EXPERIMENTAL

Parent and Adolescent Phone Call

Other: Parent and Adolescent Phone Call

Interventions

Parent Only Phone CallOTHER

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 Only Group
Parent and Adolescent Phone CallOTHER

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.

Parent and Adolescent Group

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 22908112DERIVED

Study Officials

  • Kathryn S Brigham, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

May 1, 2010

Primary Completion

July 31, 2011

Study Completion

July 31, 2011

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)