Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

June 21, 2013 updated by: University of Colorado, Denver
A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and school-based health centers. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site, with randomization at the level of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents are less likely to routinely access health care compared to younger children and adults. In addition, other obstacles such as lack of health insurance, missed opportunities for vaccination during health care visits, and the scattering of immunization records across multiple providers have posed major challenges in the vaccination of adolescents. Issues of parental consent for vaccination can also be problematic, given that adolescents may present for care without their parents accompanying them. These and other barriers to immunization may reduce the effectiveness of reminder/recall for adolescents. In the current research study, a study team with extensive experience in immunization delivery research will investigate the ability of pediatricians and family physicians in a number of different practice settings to implement a reminder/recall system for their adolescent patient populations. In addition, we will be able to examine the effectiveness of reminder/recall originating at public school-based health centers, an innovative strategy that has not previously been reported. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site. The study team will track important process measures during reminder/recall including the percentage of the eligible population who actually received intervention; percentage with incorrect addresses; percentage with incorrect or disconnected phones; percentage actually up-to-date but incorrectly recalled; missed vaccination opportunities; and invalid doses of vaccines administered. In this way, we will be able to not only determine the degree to which reminder/recall was successful for adolescents, but also identify impediments to success, which will provide a foundation for future efforts. Our study will also investigate the cost of establishing and operating a reminder/recall system for adolescents in each type of clinical setting.

Major Hypotheses

  1. Reminder/recall of adolescents will result in an increased rate of receipt of immunizations in private settings of approximately 10 percentage points
  2. Reminder/recall will result in a greater rate of receipt of immunizations when patients in public settings have access to a school-based health center (SBHC) compared to when they do not have access to a SBHC
  3. Reminder/recall originating at SBHC sites will result in the highest efficacy of reminder/recall among all the types of clinical sites

Study Type

Interventional

Enrollment (Actual)

4807

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children ages 11-18
  • seen in practice in last 2 years
  • not up-to-date on any or all shots (Tdap, HPV, meningococcal)
  • parents agree to participate in Colorado Immunization and Information System registry

Exclusion Criteria:

  • up-to-date on all vaccines
  • under age 11 over age 18
  • patients who have moved or gone elsewhere at each practice setting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reminder/recall notices for vaccines
This group will receive up to 4 recall messages (both letters and computer-generated phone messages) reminding them to get their vaccines. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients.
Other: Reminder/recall notices for vaccines
  1. Receive a generic letter reminding them to make an appointment to get vaccines.
  2. Receive a computer-generated telephone message at 1 week post initial letter.
  3. Receive a computer-generated telephone message at 2 months post initial letter.
  4. Receive a letter at 3 months post initial letter.
No Intervention: Usual Care
This group will receive usual care. There are 4 separate study groups: 1) private pediatric patients 2) public pediatric patients 3) school-based health center patients and 4) family medicine patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1) the percentage receiving any vaccine after the baseline time point
Time Frame: 6 months after intervention
6 months after intervention
The percentage of adolescents becoming up-to-date on all needed immunizations
Time Frame: 6 months post intervention
6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 10, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0763
  • U01IP000129 (U.S. NIH Grant/Contract)

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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