Universal Screening for Tuberculosis and Anemia With the CHICA System

This study has been completed.

Sponsor:

Collaborator:

National Library of Medicine (NLM)

Information provided by:

Indiana University

ClinicalTrials.gov Identifier:

NCT01322841

First received: March 23, 2011

Last updated: March 24, 2011

Last verified: July 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2011
Last Updated Date	March 24, 2011
Start Date ^ICMJE	October 2007
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 24, 2011)	Percentage of patients screened for one of the disorders [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01322841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 24, 2011)	Percentage of patients diagnosed with one of the disorders [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Universal Screening for Tuberculosis and Anemia With the CHICA System
Official Title ^ICMJE	Universal Screening for Tuberculosis and Anemia With the CHICA System
Brief Summary	The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.
Detailed Description	The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Tuberculosis Iron Deficiency Anemia
Intervention ^ICMJE	Other: CHICA diagnosis module The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia Other: CHICA Placebo This was CHICA without the screening module
Study Arm (s)	Active Comparator: CHICA Screening Module This arm had the CHICA screening module turned on Intervention: Other: CHICA diagnosis module Placebo Comparator: CHICA Screening Control This arm had CHICA but no additional module Intervention: Other: CHICA Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3250
Completion Date	September 2010
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 3 to 11 years old and seen in a study clinic Exclusion Criteria: None
Gender	Both
Ages	3 Years to 11 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01322841
Other Study ID Numbers ^ICMJE	CHICA_Screening
Has Data Monitoring Committee	No
Responsible Party	Aaron E. Carroll, MD, MS, Children's Health Services Research
Study Sponsor ^ICMJE	Indiana University
Collaborators ^ICMJE	National Library of Medicine (NLM)
Investigators ^ICMJE	Not Provided
Information Provided By	Indiana University
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top