Age-Specific Strategies for Immunization Reminders and Recalls

January 16, 2013 updated by: Kevin Dombkowski, University of Michigan
The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5456
        • University of Michigan, Child Health Evaluation and Research (CHEAR) Unit

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

7 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 7 and 19 month recall groups: children not up to date for at least one vaccination at the time of notification
  • 12 month reminder group: 12 months of age at time of notification
  • Hib vaccination series was not assessed due to a vaccine shortage

Exclusion Criteria:

  • Children were ineligible for notifications if they were designated in the Michigan Care Improvement Registry (MCIR)as having died, documented previously as having moved out of the jurisdiction ("Moved or Gone Elsewhere" (MOGE)), opted out of MCIR by their parent, or if they had been previously mailed for MCIR reminder/recall activity in the prior 60 days.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No reminder / recall notice
No childhood vaccination reminder / recall notification sent. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall
Experimental: mailed reminder / recall notice
Childhood vaccination reminder / recall notification sent by postal mail. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall
Behavioral: Childhood vaccination reminder / recall notification
Other Names:
  • Reminder / recall notifications sent by postal mail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new immunization doses
Time Frame: within 60 days of reminder notification
Receipt of 1 or more childhood vaccinations with administration date following reminder notification date
within 60 days of reminder notification

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of vaccination reminder
Time Frame: During the time of reminder notification preparation and mailing and approximately 1 month following mailing
Estimated personnel costs to generate reminder notifications, print, fold / stuff envelopes and follow up on undeliverable notifications
During the time of reminder notification preparation and mailing and approximately 1 month following mailing
historical immunization doses
Time Frame: within 60 days of reminder notification
One or more vaccination recorded with the date of administration prior to the reminder notification date
within 60 days of reminder notification
waived doses
Time Frame: within 60 days of reminder notification
One or more immunization waiver (non-administration) recorded with the date following the date of reminder notification
within 60 days of reminder notification

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Kevin J Dombkowski, DrPH, MS, University of Michigan, Child Health Evaluation and Research (CHEAR) Unit

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)

September 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U01IP000088-01 (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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