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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312805
First Posted: March 11, 2011
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
  Purpose

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.

Condition Intervention
Asthma Other: CHICA Asthma Module Other: CHICA Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting

Further study details as provided by Aaron Carroll, Indiana University:

Primary Outcome Measures:
  • Diagnosis Rate of Asthma [ Time Frame: one year ]

Enrollment: 2098
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHICA Control
This arm received CHICA without the asthma module
Other: CHICA Control
This is CHICA without the asthma module, and was used as a control
Experimental: CHICA Asthma Module
This arm received the CHICA asthma module
Other: CHICA Asthma Module
This module was added to CHICA to help diagnose and manage asthma

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?
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312805


Locations
United States, Indiana
Wishard Primary Care Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Aaron E Carroll, MD, MS Indiana University School of Medicine
  More Information

Responsible Party: Aaron Carroll, Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT01312805     History of Changes
Other Study ID Numbers: CHICA_Asthma_Study
First Submitted: March 9, 2011
First Posted: March 11, 2011
Results First Submitted: December 8, 2016
Results First Posted: February 2, 2017
Last Update Posted: March 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aaron Carroll, Indiana University:
asthma
clinical decision support
CHICA

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases


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