Trial record 8 of 56 for:    immunization [CONDITION] AND child [AGE-GROUP] | Open Studies

Immunization Protection in Child Care (IPiCC) Project

This study is currently recruiting participants.
Verified January 2013 by University of Utah
Sponsor:
Collaborators:
Utah Department of Health
Information provided by (Responsible Party):
Julie Shakib, University of Utah
ClinicalTrials.gov Identifier:
NCT01773759
First received: January 13, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Up-to-date Immunization Status for Children in Child Care
Behavioral: Intervention child care programs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Strategies to Improve Vaccination Coverage in Child Care Centers and Preschools

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Children enrolled in child care program up-to-date for required immunizations [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention child care programs
Intervention child care programs will receive immunization outreach and education.
Behavioral: Intervention child care programs
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773759

Contacts
Contact: Julie H. Shakib, DO, MPH julie.shakib@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shakib         
Principal Investigator: Julie H. Shakib, DO, MPH         
Principal Investigator: Mandy A. Allison, MD, MSPH         
Sponsors and Collaborators
University of Utah
Utah Department of Health
Investigators
Principal Investigator: Julie H. Shakib, DO, MPH University of Utah
  More Information

No publications provided

Responsible Party: Julie Shakib, Julie H. Shakib, DO, MPH, University of Utah
ClinicalTrials.gov Identifier: NCT01773759     History of Changes
Other Study ID Numbers: IP000500, RFA-IP-11-006
Study First Received: January 13, 2013
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Immunizations
Child care
School health promotion

ClinicalTrials.gov processed this record on April 17, 2014