Teen VaxScene Educational Vaccination 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: April 30, 2014
Last verified: April 2014
  Purpose

This protocol describes two interrelated studies about vaccination uptake among adolescents. The purpose of the first study is to determine whether parents in 2 primary care practices in Oakland County, Michigan who receive email reminders in addition to periodic postal mail reminders will be more likely to obtain Tdap, HPV (human papilloma virus), meningococcal, and influenza vaccines for their adolescent children than parents who receive only postal reminders. The purpose of the second study is to similarly determine the impact of email and postal mail versus postal mail only reminders in 4 primary care practices in Kalamazoo County, Michigan. Additionally, the second study will assess the role of tailored versus untailored educational information in improving parental vaccination intention and vaccine uptake among adolescents.


Condition Intervention
Adolescent Vaccination Status
Behavioral: Vaccination Email Reminder: Study 1 and 2
Behavioral: Tailored Educational Messaging: Study 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Teen VaxScene Vaccination Reminder and Information Intervention

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

Primary Outcome Measures:
  • Effect of Mailed Reminders: Study 1 and 2 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    To examine the effect(s) of email vaccination reminders, there are two types of primary outcomes to be measured:

    1. Changes in the vaccination levels (for four adolescent vaccines) of children of parents who receive monthly email vaccination reminders between the start of the study and after the study has concluded; and
    2. Differences in vaccination levels (for four adolescent vaccines) between children of parents who receive email reminders plus usual reminders and children whose parents receive only postal mail reminder strategies.


Secondary Outcome Measures:
  • Effect of Using an Informational Kiosk: Study 1 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Kiosk utilization will be considered as a potential modifying variable to adolescent vaccination rates in the larger analysis that investigates the impact of email vs. no email reminders on vaccine utilization. We will also determine any differences in parental vaccination intentions for their adolescent children at baseline and after reviewing educational material provided by the intervention.

  • Characteristics of Parents Who Use the Intervention: Study 1 and 2 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To help target the most appropriate population for future interventions, we will also determine the characteristics of parents who were most likely to access clinic waiting room kiosks and the educational web intervention for vaccine-related information.

  • Effect of Tailored vs Untailored Web-based Information: Study 2 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    To examine the effect(s) of a web-based educational information intervention, there are two types of primary outcomes to be measured:

    1. Changes in the parental vaccination intention for their adolescent children (for four adolescent vaccines) among those who access the educational intervention; and
    2. Differences in vaccination levels (for four adolescent vaccines) between children of parents who receive tailored education in the intervention and children whose parents receive only untailored education.


Enrollment: 42
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Email reminder group - Study 1 and 2
This group of parents in the study will receive email notifications about due/overdue vaccines for their adolescents, in addition to the "usual care" postal mail notifications. 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: Vaccination Email Reminder: Study 1 and 2
This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization. We will test the effects of these reminder/recall strategies along with and in conjunction with educational efforts on improving vaccination coverage rates that employ new technologies for electronic information sharing.
Usual care recall group - Study 1 and 2
This group of parents in the study will receive the "usual care" from practices. These parents will continue to receive postal mail recall notifications from these clinics that are already in place. Postal mail recall notifications are performed by the practices up to four times a year. At each time, the practices' clinical staffs review vaccination records to identify children who are overdue for any vaccines recommended by the Centers for Disease Control and Prevention's Advisory Committee of Immunization Practices (ACIP) and their children's doctors. The parents of these children are sent letters by postal mail notifying them that their children are overdue for vaccines and requesting that they schedule appointments for their children.
Behavioral: Vaccination Email Reminder: Study 1 and 2
This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization. We will test the effects of these reminder/recall strategies along with and in conjunction with educational efforts on improving vaccination coverage rates that employ new technologies for electronic information sharing.
Untailored educational group - Study 2
This group will receive untailored information that is found on the Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention (CDC). VIS sheets are freely available at these clinics in paper form as well as online from the CDC and are required to be provided to parents by medical providers prior to administering any immunizations.
Behavioral: Tailored Educational Messaging: Study 2
This study will determine whether an educational web intervention that delivers individually-tailored educational information about adolescent vaccines increases parental vaccination intention as well as actual vaccine uptake among adolescents.
Experimental: Tailored educational group - Study 2
This group will receive tailored educational messages that use parent-reported information to address their specific concerns and beliefs about adolescent vaccines. Both groups will view educational web pages that are similar-appearing in design and differ primarily in content presentation (untailored versus tailored information) to isolate the impact of tailoring.
Behavioral: Tailored Educational Messaging: Study 2
This study will determine whether an educational web intervention that delivers individually-tailored educational information about adolescent vaccines increases parental vaccination intention as well as actual vaccine uptake among 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.

An additional barrier is that parents report not knowing enough about vaccinations to feel comfortable with the decision to allow their child to be vaccinated. Although parents would like more information about vaccines, providers lack adequate time during clinical encounters to address all parental concerns. Many parents use the Internet to gather additional information about vaccines, however, many websites provide inaccurate information and/or fail to address the specific concerns that parents may have. Individual message tailoring, whereby educational materials are individually crafted to address each person's specific beliefs, concerns and experiences, has been shown to be more effective than providing generic information for compliance with a number of preventive health activities.

  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 11-17) attending one of 6 participating pediatric practices,
  • Able to read and converse in English,
  • Has active email address in time to participate.

Exclusion Criteria:

  • Parent age <18 years,
  • 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: April 30, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014