- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01732315
Adolescent Vaccination Reminder Study
Adolescent Vaccination Reminders Using Email
Study Overview
Status
Conditions
Intervention / Treatment
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, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
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No Intervention: Usual Care
This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
New immunization doses
Time Frame: New immunizations within 60 days of reminder notification
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To examine the effect of email vaccination reminders, new immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined.
New doses are those for any of four adolescent vaccines which are administered following the reminder notification, and are subsequently recorded following reminder notifications.
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New immunizations within 60 days of reminder notification
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waived immunization doses
Time Frame: Waived immunizations within 60 days of reminder notification
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To examine the effect of email vaccination reminders, waived immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined.
Waived doses are those for any of four adolescent vaccines for which medical, religious, or philosophical waivers are subsequently recorded following reminder notifications.
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Waived immunizations within 60 days of reminder notification
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Historical immunization doses
Time Frame: Historical immunizations within 60 days of reminder notification
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To examine the effect of email vaccination reminders, historical immunization doses of children of parents who receive email vaccination reminders, versus those who do not receive email reminders during the study period will be determined.
Historical doses are those for any of four adolescent vaccines which are administered prior to the reminder notification and are subsequently recorded following reminder notifications.
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Historical immunizations within 60 days of reminder notification
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin Dombkowski, DrPH, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-0378
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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