Age-Specific Strategies for Immunization Reminders and Recalls

Childhood Vaccination Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770496
• Other study ID #: U01IP000088-01
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 16, 2013
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10175
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Months to 19 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Childhood Vaccination

Intervention

Behavioral:
• Childhood vaccination reminder / recall notification

Locations

Country	Name	City	State
United States	University of Michigan, Child Health Evaluation and Research (CHEAR) Unit	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new immunization doses	Receipt of 1 or more childhood vaccinations with administration date following reminder notification date	within 60 days of reminder notification	No
Secondary	Cost of vaccination reminder	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	No
Secondary	historical immunization doses	One or more vaccination recorded with the date of administration prior to the reminder notification date	within 60 days of reminder notification	No
Secondary	waived doses	One or more immunization waiver (non-administration) recorded with the date following the date of reminder notification	within 60 days of reminder notification	No