Adolescent Vaccination Reminder Study

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01732315
First received: October 24, 2012
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

This protocol describes a study about vaccination uptake among adolescents. The purpose of the study is to determine whether parents who receive email reminders will be more likely to obtain Tdap, HPV (human papilloma virus), meningococcal, and influenza vaccines for their adolescent children than parents who do not receive email reminders.


Condition Intervention
Adolescent Vaccination Status
Behavioral: Email Notification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Adolescent Vaccination Reminders Using Email

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • New immunization doses [ Time Frame: New immunizations within 60 days of reminder notification ] [ Designated as safety issue: No ]
    To examine the effect of email vaccination reminders, new immunization doses (for four adolescent vaccines) of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined.


Secondary Outcome Measures:
  • Waived immunization doses [ Time Frame: Waived immunizations within 60 days of reminder notification ] [ Designated as safety issue: No ]
    To examine the effect of email vaccination reminders, waived immunization doses (for four adolescent vaccines) of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined.


Enrollment: 3783
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination Email Reminder
This group of parents in the study will receive email notifications about due/overdue vaccines for their adolescents. Vaccination records will be reviewed to identify adolescent patients in both practices who are newly eligible for a vaccine and/or overdue for a vaccine at the start of every other month. Email notifications will then be sent to the parents of these children.
Behavioral: Email Notification
This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
No Intervention: Usual Care
This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents.

Detailed Description:

Adolescents are a reservoir population for a variety of vaccine preventable diseases (VPDs). Despite this, adolescent vaccination rates lag substantially behind national goals of 80% coverage for adolescent vaccines set forth by Healthy People 2020. This has been particularly the case for the vaccines most recently recommended for adolescents, such as the HPV (human papilloma virus) and seasonal influenza (flu) vaccines; national coverage levels in 2010 for HPV were 32% (for series completion among females only) and 35% for flu vaccine. Uptake levels for the two other adolescent-targeted vaccines, tetanus-diphtheria-acellular pertussis (Tdap) and meningococcal conjugate (MCV4) vaccines are currently at 69% and 63%, respectively.

A major barrier to increased adolescent vaccination levels is the lack of parental and provider recognition that an adolescent is due for vaccine doses. For providers, there are the dual challenges of getting adolescents to come in for annual preventive care visits and also minimizing "missed opportunities" for vaccination (i.e. clinical interactions with a patient where a needed vaccine could have been provided but was not). Reminder/recall systems are one mechanism to help address both of these challenges for providers while also informing parents about the need for adolescent vaccines.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents of adolescents (Ages 11-18) have children who attend one of 4 participating pediatric practices,
  • Parents are able to read and converse in English,
  • Parents have an active email address that is associated with their child's medical record,
  • Parents have an adolescent whose medical record can be matched with their MCIR record.

Exclusion Criteria:

  • Parent age <18 years,
  • Parents have an invalid or non-working parent email address,
  • Parents have opted out of email communication,
  • Prisoners,
  • Decisionally challenged participants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732315

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Colorado, Denver
University of Michigan
Investigators
Principal Investigator: Kevin Dombkowski, DrPH University of Michigan
Principal Investigator: Amanda Dempsey, MD, PhD, MPH University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01732315     History of Changes
Other Study ID Numbers: 12-0378
Study First Received: October 24, 2012
Last Updated: July 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Adolescent vaccination
Immunization rates
Barriers to vaccination
Attitudes
Intentions

ClinicalTrials.gov processed this record on July 28, 2015