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Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting

Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01312805
Enrollment
2098
Registered
2011-03-11
Start date
2005-07-31
Completion date
2008-07-31
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, clinical decision support, CHICA

Brief summary

This study seeks to improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines: 1. Improve case detection of asthma among patients with pulmonary symptoms, 2. Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma, 3. Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma, 4. Provide an asthma treatment plan for all asthma patients.

Detailed description

Objectives: Improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines: 1. Improve case detection of asthma among patients with pulmonary symptoms, 2. Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma, 3. Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma, 4. Provide an asthma treatment plan for all asthma patients. Design: This will be a randomized controlled trial. Patients registering for appointments at the PCC Pediatric clinic will be randomized to an intervention or control arm. Patients in the intervention arm, and the physicians who see them, will receive the full intervention. Patients in the control arm will receive usual care. Intervention: The CHICA computer system has been in regular use at the PCC Pediatrics clinic since November 4, 2004. At patient check-in, CHICA produces a health survey that parents complete in the weighting room. The survey is scanned into CHICA before the physician encounter. CHICA produces a worksheet for the physician that includes prompts and reminders based date from the health survey and the electronic medical record. The completer worksheet is scanned back into CHICA. Intervention and control groups will continue to use this system In the intervention group, CHICA will include a question asking for the presence of asthma or asthma symptoms on the health survey. If the family responds that asthma or symptoms of asthma are present, CHICA will: 1. Alert the physician and ask him or her to confirm or deny the presence of asthma and to rate the asthma as persistent or intermittent, 2. Generate a chart showing the criteria for each asthma grade, 3. Recommend controller medications if the patient has persistent asthma and ask the physician to document if controllers were prescribed, 4. Generate a partially completed treatment plan for the physician to complete and give to the patient. For patients confirmed to have asthma, CHICA will place a question on the health survey at subsequent visits that assesses symptoms. For patients who have been prescribed controller medications, CHICA will put a question on the health survey asking about patient adherence to the medication. The physician worksheet will alert the physician to changes in the patient's symptom status or to non-adherence to controller medication, in compliance with NHLBI guidelines. Outcome Measures: To determine the rates of asthma case finding in the intervention and control groups, we will pull the RMRS electronic records of all patients seen during the first 6 months of the trial and determine the prevalence of diagnoses for asthma (ICD-9 code equal to 493.\*). After 6 months of running the trial, we will randomly select from those patients in the trial who have an ICD-9 diagnosis of asthma (493.\*), 75 patients from the intervention group and 75 patients from the control group. The paper shadow charts for these patients will be pulled from the chart room at the PCC Pediatrics clinic. Trained chart reviewers will document the following: 1. Has the patient's asthma been graded as intermittent or persistent? 2. Is there documentation of an asthma treatment plan? 3. Has the patient been prescribed a controller medication?

Interventions

OTHERCHICA Asthma Module

This module was added to CHICA to help diagnose and manage asthma

OTHERCHICA Control

This is CHICA without the asthma module, and was used as a control

Sponsors

Indiana University
Lead SponsorOTHER

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

* Families who visit the Wishard/IUMG Primary Care Center (PCC) pediatric clinic are eligible for our study. Families are randomly assigned to either the control or intervention group, where they will remain for the study's duration. No blocking or other methods of stratification are used. There are no additional

Exclusion criteria

. Data collection will occur for a minimum of 6 months and not to exceed two years

Design outcomes

Primary

MeasureTime frame
Diagnosis Rate of Asthmaone year

Countries

United States

Participant flow

Participants by arm

ArmCount
CHICA Control
This arm received CHICA without the asthma module CHICA Control: This is CHICA without the asthma module, and was used as a control
1,016
CHICA Asthma Module
This arm received the CHICA asthma module CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma
1,082
Total2,098

Baseline characteristics

CharacteristicCHICA ControlCHICA Asthma ModuleTotal
Age, Categorical
<=18 years
1016 Participants1082 Participants2098 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
515 Participants530 Participants1045 Participants
Sex: Female, Male
Male
501 Participants552 Participants1053 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1,0160 / 1,082
serious
Total, serious adverse events
0 / 1,0160 / 1,082

Outcome results

Primary

Diagnosis Rate of Asthma

Time frame: one year

Population: We excluded those participants who had a previous diagnosis of asthma in the 14 months before the start of the study. This left the numbers seen above.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CHICA ControlDiagnosis Rate of Asthma54 Participants
CHICA Asthma ModuleDiagnosis Rate of Asthma87 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026