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.
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
About this study
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.
Read the 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?
- 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 group | Role | What they receive |
|---|---|---|
| CHICA Control | Active comparator | This arm received CHICA without the asthma module Receives: Other: CHICA Control |
| CHICA Asthma Module | Experimental | This 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.
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.
- First posted11 Mar 2011 (estimated)
- Study startJul 2005
- Primary completionApr 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- Aaron E Carroll, MD, MS, Principal investigator, Indiana University
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting
- ClinicalTrials.gov ID
- NCT01312805
- Acronym / sponsor ID
- CHICA_Asthma_Study
- Conditions
- Asthma
- Keywords
- asthma, clinical decision support, CHICA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,098 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 2 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHICA Control | Active comparator | Other: CHICA ControlThis arm received CHICA without the asthma module |
| CHICA Asthma Module | Experimental | Other: CHICA Asthma ModuleThis arm received the CHICA asthma module |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHICA Asthma ModuleThis module was added to CHICA to help diagnose and manage asthma | Other | CHICA Asthma Module |
| CHICA ControlThis is CHICA without the asthma module, and was used as a control | Other | CHICA Control |
Primary outcome
Diagnosis Rate of Asthma
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron E Carroll, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
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.