NCT01770496

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

January 15, 2013

Last Update Submit

January 16, 2013

Conditions

Keywords

immunizationvaccinationimmunization information systemimmunization registryreminder / recall

Outcome Measures

Primary Outcomes (1)

  • new immunization doses

    Receipt of 1 or more childhood vaccinations with administration date following reminder notification date

    within 60 days of reminder notification

Secondary Outcomes (3)

  • Cost of vaccination reminder

    During the time of reminder notification preparation and mailing and approximately 1 month following mailing

  • historical immunization doses

    within 60 days of reminder notification

  • waived doses

    within 60 days of reminder notification

Study Arms (2)

No reminder / recall notice

NO INTERVENTION

No childhood vaccination reminder / recall notification sent. Stratified by age cohort of subjects: 7 month recall; 12 month reminder; 19 month recall

mailed reminder / recall notice

EXPERIMENTAL

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

Interventions

Also known as: Reminder / recall notifications sent by postal mail
mailed reminder / recall notice

Eligibility Criteria

Age7 Months - 19 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan, Child Health Evaluation and Research (CHEAR) Unit

Ann Arbor, Michigan, 48109-5456, United States

Location

Related Publications (1)

  • Dombkowski KJ, Costello LE, Harrington LB, Dong S, Kolasa M, Clark SJ. Age-specific strategies for immunization reminders and recalls: a registry-based randomized trial. Am J Prev Med. 2014 Jul;47(1):1-8. doi: 10.1016/j.amepre.2014.02.009. Epub 2014 Apr 18.

Study Officials

  • Kevin J Dombkowski, DrPH, MS

    University of Michigan, Child Health Evaluation and Research (CHEAR) Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations