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

NCT ID: NCT01312805

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2098 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-07-31

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?

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CHICA Control

This arm received CHICA without the asthma module

Group Type: ACTIVE_COMPARATOR

CHICA Control

Intervention Type: OTHER

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

CHICA Asthma Module

This arm received the CHICA asthma module

Group Type: EXPERIMENTAL

CHICA Asthma Module

Intervention Type: OTHER

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

Interventions

CHICA Asthma Module

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

Intervention Type: OTHER

CHICA Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria:

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Carroll

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron E Carroll, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Wishard Primary Care Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CHICA_Asthma_Study

Identifier Type: -

Identifier Source: org_study_id