- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622608
Adolescent Vaccination Kiosk Project
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 human papillomavirus (HPV) 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Centennial, Colorado, United States, 80112
- Pediatrics 5280
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Thornton, Colorado, United States, 80260
- Mountainland Pediatrics
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Wheat Ridge, Colorado, United States, 80033
- Pediatrics West
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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 (11-17 years) attending one of 3 participating pediatric practices.
- able to read and converse in English.
Exclusion Criteria:
- Parent age < 18 years,
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kiosk Users
|
The study kiosk will remain in the waiting room of participating practices for the duration of the study.
Interested parents will self-direct to the kiosk in the clinic waiting room either before or after their child's appointment.
Following consent, parents will complete a survey that assesses socio-demographics, baseline vaccination intention, and vaccine-specific beliefs, attitudes and experiences.
The kiosk will generate tailored educational messages about adolescent vaccines.
Parents can utilize the kiosk as many times as they wish during the intervention period.
|
No Intervention: Non-Kiosk Users
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of vaccine information kiosks by parents/patients.
Time Frame: 12 months
|
Descriptive statistics on kiosk utilization patterns overall, and disaggregated by various demographic, attitudinal and vaccination status categories will be derived.
This will be assessed in intervention settings using data entered by parents, as well as paradata such as the order of web pages viewed, and time spent per page.
|
12 months
|
Usefulness of vaccine information kiosks
Time Frame: 12 months (provider survey) & 3 months (parent survey)
|
Parent satisfaction with the material presented in the kiosk, as well as changes between parents' baseline survey (done at the kiosk) and follow-up email survey in: 1) parent attitudes about vaccination and 2) parent vaccine-specific vaccination intention will be assessed.
Provider views on having the kiosks in the waiting room of their clinic will also be assessed.
|
12 months (provider survey) & 3 months (parent survey)
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Proportion of adolescents who had a change in their vaccination status in kiosk users compared to non-users.
Time Frame: 12 months
|
Vaccination status will be determined primarily by medical record review, and augmented by parent report.
The proportion of adolescents who had a change in their vaccination status (Tdap, MCV, HPV, Flu) before versus after their clinic visit (for non-users of the kiosk), or before versus after the date their parent first accessed the intervention (for users of the kiosk) will be assessed.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Dempsey, MD, PhD, MPH, University of Colorado, Children's Hospital Colorado
- Principal Investigator: Sean O'Leary, MD, MPH, University of Colorado Denver, Children's Hospital Colorado
- Principal Investigator: Lawrence An, MD, University of Michigan, Masonic Cancer Center
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
Keywords
Other Study ID Numbers
- 12-0179
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.
Clinical Trials on Adolescent Vaccination Status
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University of Colorado, DenverUniversity of Michigan; Centers for Disease Control and PreventionCompleted
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University of Colorado, DenverUniversity of MichiganCompletedHPV Vaccination StatusUnited States
-
Lancaster UniversityPennine Acute Hospitals NHS TrustCompletedVaccination/Immunisation StatusUnited Kingdom
-
University of PennsylvaniaCompletedVaccine Refusal | Vaccination Hesitancy | Human Papillomavirus VaccinationUnited States
-
University of Roma La SapienzaCompletedVaccination Failure | Vaccination Adverse Events | Specific Antibody ResponseItaly
-
National Cancer Institute (NCI)CompletedHPV16 Anitbody Levels Post Vaccination | HPV18 Antibody Levels Post VaccinationUganda
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China National Biotec Group Company LimitedShanghai Municipal Center for Disease Control and PreventionCompleted
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-
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