Age-Specific Strategies for Immunization Reminders and Recalls

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kevin Dombkowski, University of Michigan
ClinicalTrials.gov Identifier:
NCT01770496
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Childhood Vaccination
Behavioral: Childhood vaccination reminder / recall notification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • new immunization doses [ Time Frame: within 60 days of reminder notification ] [ Designated as safety issue: No ]
    Receipt of 1 or more childhood vaccinations with administration date following reminder notification date


Secondary Outcome Measures:
  • Cost of vaccination reminder [ Time Frame: During the time of reminder notification preparation and mailing and approximately 1 month following mailing ] [ Designated as safety issue: No ]
    Estimated personnel costs to generate reminder notifications, print, fold / stuff envelopes and follow up on undeliverable notifications

  • historical immunization doses [ Time Frame: within 60 days of reminder notification ] [ Designated as safety issue: No ]
    One or more vaccination recorded with the date of administration prior to the reminder notification date

  • waived doses [ Time Frame: within 60 days of reminder notification ] [ Designated as safety issue: No ]
    One or more immunization waiver (non-administration) recorded with the date following the date of reminder notification


Enrollment: 10175
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Reminder / recall notifications sent by postal mail

  Eligibility

Ages Eligible for Study:   7 Months to 19 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770496

Locations
United States, Michigan
University of Michigan, Child Health Evaluation and Research (CHEAR) Unit
Ann Arbor, Michigan, United States, 48109-5456
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Kevin J Dombkowski, DrPH, MS University of Michigan, Child Health Evaluation and Research (CHEAR) Unit
  More Information

No publications provided

Responsible Party: Kevin Dombkowski, Research Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01770496     History of Changes
Other Study ID Numbers: U01IP000088-01
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
immunization
vaccination
immunization information system
immunization registry
reminder / recall

ClinicalTrials.gov processed this record on July 24, 2014