Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

NCT ID: NCT01431183

Last Updated: 2011-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

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The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.

Detailed Description

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Conditions

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Seasonal Influenza Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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mailed reminder notice

Seasonal influenza vaccination reminder sent by postal mail

Group Type ACTIVE_COMPARATOR

Mailed influenza vaccination reminder notice

Intervention Type BEHAVIORAL

Influenza vaccination reminder sent by postal mail

No reminder notice

No seasonal influenza vaccination reminder sent by postal mail

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mailed influenza vaccination reminder notice

Influenza vaccination reminder sent by postal mail

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* children, 24-60 months
* current or previous enrollment in Medicaid (Michigan)
* presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
* resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion Criteria

* receipt of influenza prior to notification date
* ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
Minimum Eligible Age

24 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kevin Dombkowski

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin J Dombkowski, DrPH, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan, Child Health Evaluation and Research Unit

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Dombkowski KJ, Harrington LB, Dong S, Clark SJ. Seasonal influenza vaccination reminders for children with high-risk conditions: a registry-based randomized trial. Am J Prev Med. 2012 Jan;42(1):71-5. doi: 10.1016/j.amepre.2011.09.028.

Reference Type DERIVED
PMID: 22176850 (View on PubMed)

Other Identifiers

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5U01IP000132

Identifier Type: NIH

Identifier Source: org_study_id

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