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Universal Screening for Tuberculosis and Anemia With the CHICA System

Primary Purpose

Tuberculosis, Iron Deficiency Anemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CHICA Diagnosis Module

CHICA Placebo

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring CHICA, clinical decision support

Eligibility Criteria

3 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 3 to 11 years old and seen in a study clinic

Exclusion Criteria:

None

Sites / Locations

Children's Health Services Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CHICA Diagnosis Module

CHICA Placebo

Arm Description

This arm had the CHICA screening module turned on

This arm had CHICA but no additional module

Outcomes

Primary Outcome Measures

Percentage of Patients Screened Positive for One of the Disorders

Secondary Outcome Measures

Percentage of Patients Diagnosed With One of the Disorders

Full Information

NCT ID

NCT01322841

First Posted

March 23, 2011

Last Updated

October 21, 2016

Sponsor

Indiana University

Collaborators

National Library of Medicine (NLM)

1. Study Identification

Unique Protocol Identification Number

NCT01322841

Brief Title

Universal Screening for Tuberculosis and Anemia With the CHICA System

Official Title

Universal Screening for Tuberculosis and Anemia With the CHICA System

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Library of Medicine (NLM)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis, Iron Deficiency Anemia

Keywords

CHICA, clinical decision support

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

2239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHICA Diagnosis Module

Arm Type

Active Comparator

Arm Description

This arm had the CHICA screening module turned on

Arm Title

CHICA Placebo

Arm Type

Placebo Comparator

Arm Description

This arm had CHICA but no additional module

Intervention Type

Other

Intervention Name(s)

CHICA Diagnosis Module

Intervention Description

The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia

Intervention Type

Other

Intervention Name(s)

CHICA Placebo

Intervention Description

This was CHICA without the screening module

Primary Outcome Measure Information:

Title

Percentage of Patients Screened Positive for One of the Disorders

Time Frame

six months

Secondary Outcome Measure Information:

Title

Percentage of Patients Diagnosed With One of the Disorders

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 3 to 11 years old and seen in a study clinic Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron E Carroll, MD, MS

Organizational Affiliation

IUSM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Health Services Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Universal Screening for Tuberculosis and Anemia With the CHICA System

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