Iron Deficiency Anemia, Tuberculosis
Conditions
Keywords
CHICA, clinical decision support
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.
Interventions
OTHERCHICA Diagnosis Module
The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
OTHERCHICA Placebo
This was CHICA without the screening module
Sponsors
National Library of Medicine (NLM)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
Age 3 to 11 years old and seen in a study clinic
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Screened Positive for One of the Disorders | six months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients Diagnosed With One of the Disorders | six months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHICA Diagnosis Module This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia | 1,116 |
| CHICA Placebo This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module | 1,123 |
| Total | 2,239 |
Baseline characteristics
| Characteristic | CHICA Diagnosis Module | CHICA Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1116 Participants | 1123 Participants | 2239 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 394 Participants | 397 Participants | 791 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 21 Participants | 27 Participants | 48 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 37 Participants | 57 Participants |
| Race (NIH/OMB) White | 679 Participants | 662 Participants | 1341 Participants |
| Sex: Female, Male Female | 538 Participants | 542 Participants | 1080 Participants |
| Sex: Female, Male Male | 578 Participants | 581 Participants | 1159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,116 | 0 / 1,123 |
| serious Total, serious adverse events | 0 / 1,116 | 0 / 1,123 |
Outcome results
Primary
Percentage of Patients Screened Positive for One of the Disorders
Time frame: six months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHICA Diagnosis Module | Percentage of Patients Screened Positive for One of the Disorders | Iron Deficiency | 17.5 percentage of participants |
| CHICA Diagnosis Module | Percentage of Patients Screened Positive for One of the Disorders | TB | 1.8 percentage of participants |
| CHICA Placebo | Percentage of Patients Screened Positive for One of the Disorders | Iron Deficiency | 3.1 percentage of participants |
| CHICA Placebo | Percentage of Patients Screened Positive for One of the Disorders | TB | 0.8 percentage of participants |
Secondary
Percentage of Patients Diagnosed With One of the Disorders
Time frame: six months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHICA Diagnosis Module | Percentage of Patients Diagnosed With One of the Disorders | Iron Deficiency Anemia | 0.3 percentage of participants |
| CHICA Diagnosis Module | Percentage of Patients Diagnosed With One of the Disorders | TB | 0.2 percentage of participants |
| CHICA Placebo | Percentage of Patients Diagnosed With One of the Disorders | Iron Deficiency Anemia | 0 percentage of participants |
| CHICA Placebo | Percentage of Patients Diagnosed With One of the Disorders | TB | 0 percentage of participants |