Adolescent Vaccination StatusNCT01622608
Adolescent Vaccination Kiosk Project
A study testing Vaccine Information Kiosk in people with Adolescent Vaccination Status, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether implementation of a web-based educational intervention using a "vaccine information kiosk" placed in primary care practice waiting rooms can reach a large number of parents and have a measurable impact on adolescent vaccination rates, specifically for Tdap, HPV… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Vaccination Status
- What is being tested?
- Vaccine Information Kiosk
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of adolescents (11-17 years) attending one of 3 participating pediatric practices.
- able to read and converse in English.
Who cannot join
- Parent age < 18 years,
- prisoners,
- decisionally challenged participants.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pediatrics 5280
Centennial, Colorado, 80112
Mountainland Pediatrics
Thornton, Colorado, 80260
Pediatrics West
Wheat Ridge, Colorado, 80033
About this study
The purpose of this study is to determine whether implementation of a web-based educational intervention using a "vaccine information kiosk" placed in primary care practice waiting rooms can reach a large number of parents and have a measurable impact on adolescent vaccination rates, specifically for Tdap, HPV, meningococcal, and influenza vaccines.
Read the 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.
- Conditions
- Adolescent Vaccination Status
- Being tested
- Vaccine Information Kiosk
- Keywords
- Adolescent vaccination, Immunization rates, Informational kiosk, Tailored health messaging, Barriers to vaccination, Attitudes, Intentions
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Information KioskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kiosk Users | Experimental | Not described Receives: Behavioral: Vaccine Information Kiosk |
| Non-Kiosk Users | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of vaccine information kiosks by parents/patients.
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.
Measured: 12 months
Usefulness of vaccine information kiosks
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.
Measured: 12 months (provider survey) & 3 months (parent survey)
Proportion of adolescents who had a change in their vaccination status in kiosk users compared to non-users.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Vaccination StatusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Adolescent Health & Medicine
- Responsible party
- Sponsor
- Investigators
- Amanda Dempsey, MD, PhD, MPH, Principal investigator, University of colorado, Children's Hospital ColoradoSean O'Leary, MD, MPH, Principal investigator, University of Colorado Denver, Children's Hospital ColoradoLawrence An, MD, Principal investigator, University of Michigan, Masonic Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622608
- Sponsor's protocol ID
- 12-0179
- Status last verified
- Dec 2013
- First submitted
- 15 Jun 2012
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Vaccination Kiosk Project
- ClinicalTrials.gov ID
- NCT01622608
- Acronym / sponsor ID
- 12-0179
- Conditions
- Adolescent Vaccination Status
- Keywords
- Adolescent vaccination, Immunization rates, Informational kiosk, Tailored health messaging, Barriers to vaccination, Attitudes, Intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Society for Adolescent Health & Medicine
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether implementation of a web-based educational intervention using a "vaccine information kiosk" placed in primary care practice waiting rooms can reach a large number of parents and have a measurable impact on adolescent vaccination rates, specifically for Tdap, HPV, meningococcal, and influenza vaccines.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiosk Users | Experimental | Behavioral: Vaccine Information Kiosk |
| Non-Kiosk Users | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parents of adolescents (11-17 years) attending one of 3 participating pediatric practices.
- able to read and converse in English.
Key exclusion criteria (3 listed)
- Parent age < 18 years,
- prisoners,
- decisionally challenged participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine Information KioskThe 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. | Behavioural | Kiosk Users |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Dempsey, MD, PhD, MPH principal investigator
University of colorado, Children's Hospital Colorado
Sean O'Leary, MD, MPH principal investigator
University of Colorado Denver, Children's Hospital Colorado
Lawrence An, MD principal investigator
University of Michigan, Masonic Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Information Kiosk in people with Adolescent Vaccination Status, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of vaccine information kiosks by parents/patients. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.