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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHICA Asthma Module
CHICA Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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:

Sites / Locations

  • Wishard Primary Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHICA Control

CHICA Asthma Module

Arm Description

This arm received CHICA without the asthma module

This arm received the CHICA asthma module

Outcomes

Primary Outcome Measures

Diagnosis Rate of Asthma

Secondary Outcome Measures

Full Information

First Posted
March 9, 2011
Last Updated
February 2, 2017
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01312805
Brief Title
Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting
Official Title
Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines: Improve case detection of asthma among patients with pulmonary symptoms, Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma, Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma, Provide an asthma treatment plan for all asthma patients.
Detailed Description
Objectives: Improve physician adherence to four recommendations of the NHLBI asthma treatment guidelines: Improve case detection of asthma among patients with pulmonary symptoms, Grade all asthma patients asthma, identifying those with persistent versus intermittent asthma, Improve rates of use of controller medications - particularly inhaled steroids - among patients with persistent asthma, 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: 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, Generate a chart showing the criteria for each asthma grade, Recommend controller medications if the patient has persistent asthma and ask the physician to document if controllers were prescribed, 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: Has the patient's asthma been graded as intermittent or persistent? Is there documentation of an asthma treatment plan? Has the patient been prescribed a controller medication?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, clinical decision support, CHICA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2098 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHICA Control
Arm Type
Active Comparator
Arm Description
This arm received CHICA without the asthma module
Arm Title
CHICA Asthma Module
Arm Type
Experimental
Arm Description
This arm received the CHICA asthma module
Intervention Type
Other
Intervention Name(s)
CHICA Asthma Module
Intervention Description
This module was added to CHICA to help diagnose and manage asthma
Intervention Type
Other
Intervention Name(s)
CHICA Control
Intervention Description
This is CHICA without the asthma module, and was used as a control
Primary Outcome Measure Information:
Title
Diagnosis Rate of Asthma
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron E Carroll, MD, MS
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wishard Primary Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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