Immunization Protection in Child Care (IPiCC) Project (IPiCC)

April 12, 2017 updated by: Julie Shakib, University of Utah

Strategies to Improve Vaccination Coverage in Child Care Centers and Preschools

Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.

Study Overview

Detailed Description

Specific Aim 1 will describe Utah state and local government activities to ensure compliance of child care programs with state immunization requirements and identify government's barriers to ensuring compliance.

Specific Aim 2 will describe child care program staffs' knowledge, attitudes, and activities related to ensuring that all children are up-to-date for required immunizations and identify program barriers to ensuring up-to-date status.

Specific Aim 3 will evaluate at least 3 strategies to ensure that all children enrolled in child care programs are up-to-date for required immunizations. Aims 1 and 2 will guide the design of these strategies. Specific strategies proposed for Aim 3 are to: 1) design and pilot test an intervention to increase child care program use of the Utah State Immunization Information System (USIIS), 2) design an online immunization education module and conduct a pilot randomized controlled trial to determine whether use of the module changes child care providers' knowledge, attitudes, and activities and increases the proportion of children who are up-to-date for required immunizations; and 3) conduct a pilot randomized controlled trial to determine whether a quality improvement intervention implemented in child care programs increases the proportion of children who are up-to-date for required immunizations.

Study Type

Interventional

Enrollment (Actual)

107

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

    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Child care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.

Exclusion Criteria:

Child care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention child care programs
Intervention child care programs will receive immunization outreach and education.
Interventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring.
No Intervention: Control child care programs
Control programs will receive no more than usual training regarding childhood immunization requirements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children enrolled in child care program up-to-date for required immunizations
Time Frame: Up to 2 years
Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)
Up to 2 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Julie H. Shakib, DO, MPH, University of Utah

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

September 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 13, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IP000500
  • RFA-IP-11-006 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

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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