Adolescent Vaccination StatusNCT01732315
Adolescent Vaccination Reminder Study
A study testing Email Notification in people with Adolescent Vaccination Status, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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 (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus), meningococcal, and influenza vaccines for their… 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?
- Email Notification
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,783 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2014
- 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 (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adolescent Vaccination Reminders Using Email
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 (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus), meningococcal, and influenza vaccines for their adolescent children than parents who do not receive email reminders.
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 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.
- Conditions
- Adolescent Vaccination Status
- Being tested
- Email Notification
- Keywords
- Adolescent vaccination, Immunization rates, 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.
Email NotificationBehavioural
This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination Email Reminder | Experimental | 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. Receives: Behavioral: Email Notification |
| Usual Care | No intervention | This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New immunization doses
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.
Measured: New immunizations within 60 days of reminder notification
Secondary outcomes (2)
Waived immunization doses
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.
Measured: Waived immunizations within 60 days of reminder notification
Historical immunization doses
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.
Measured: Historical immunizations within 60 days of reminder notification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,783 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kevin Dombkowski, DrPH, Principal investigator, University of MichiganAmanda Dempsey, MD, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732315
- Sponsor's protocol ID
- 12-0378
- Status last verified
- Aug 2015
- First submitted
- 24 Oct 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dombkowski KJ, Cowan AE, Reeves SL, Foley MR, Dempsey AF. The impacts of email reminder/recall on adolescent influenza vaccination. Vaccine. 2017 May 25;35(23):3089-3095. doi: 10.1016/j.vaccine.2017.04.033. Epub 2017 Apr 25.
PubMed 28455173
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Vaccination Reminders Using Email
- ClinicalTrials.gov ID
- NCT01732315
- Acronym / sponsor ID
- 12-0378
- Conditions
- Adolescent Vaccination Status
- Keywords
- Adolescent vaccination, Immunization rates, Barriers to vaccination, Attitudes, Intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,783 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Michigan, Centers for Disease Control and Prevention
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Nov 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.
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 (tetanus-diphtheria-acellular pertussis), HPV (human papilloma virus), meningococcal, and influenza vaccines for their adolescent children than parents who do not receive email reminders.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination Email Reminder | Experimental | Behavioral: Email NotificationThis 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. |
| Usual Care | No intervention | –This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Email NotificationThis study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization. | Behavioural | Vaccination Email Reminder |
Primary outcome
New immunization doses
Time frame: New immunizations within 60 days of reminder notification
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.
2 secondary outcomes
Waived immunization doses
Time frame: Waived immunizations within 60 days of reminder notification
Historical immunization doses
Time frame: Historical immunizations within 60 days of reminder notification
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 17 Aug 2015.
- Derived from this study: PubMed 28455173Dombkowski KJ, Cowan AE, Reeves SL, Foley MR, Dempsey AF. The impacts of email reminder/recall on adolescent influenza vaccination. Vaccine. 2017 May 25;35(23):3089-3095. doi: 10.1016/j.vaccine.2017.04.033. Epub 2017 Apr 25.
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.
Kevin Dombkowski, DrPH principal investigator
University of Michigan
Amanda Dempsey, MD, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Email Notification in people with Adolescent Vaccination Status, run by University of Colorado, Denver at 1 site 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 4 inclusion and 5 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 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
New immunization doses (time frame: New immunizations within 60 days of reminder notification). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732315, which also lists 1 linked publication.
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 17 Aug 2015; AzTrials last refreshed its copy on 27 Oct 2026.