Adolescent Vaccination Reminder Study

NCT ID: NCT01732315

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3783 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Vaccination Status

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Email Notification

Intervention Type BEHAVIORAL

This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.

Usual Care

This group of parents in the study will not receive email notifications about due/overdue vaccines for their adolescents.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Email Notification

This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Dombkowski, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Amanda Dempsey, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28455173 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-0378

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.