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AsthmaNCT01312805

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

A study testing CHICA Asthma Module in people with Asthma, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
CHICA Asthma Module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,098 participants
Where
1 siteUnited States
Study dates
Jul 2005to Jul 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wishard Primary Care Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.
Read the 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
Being tested
CHICA Asthma Module, CHICA Control
Keywords
asthma, clinical decision support, CHICA
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHICA Asthma ModuleOther

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

  • CHICA ControlOther

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

Study groups in NCT01312805
Study groupRoleWhat they receive
CHICA ControlActive comparatorThis arm received CHICA without the asthma module
Receives: Other: CHICA Control
CHICA Asthma ModuleExperimentalThis arm received the CHICA asthma module
Receives: Other: CHICA Asthma Module

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnosis Rate of Asthma

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2011 (estimated)
  2. Study startJul 2005
  3. Primary completionApr 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
2,098 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01312805
Sponsor's protocol ID
CHICA_Asthma_Study
Status last verified
Feb 2017
First submitted
9 Mar 2011
Last updated
14 Mar 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CHICA Asthma Module in people with Asthma, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis Rate of Asthma (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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