A Computerized Asthma Management System in the Pediatric Emergency Department
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Asthma Management System
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma focused on measuring asthma, emergency medicine, medical informatics, computerized reminder systems
Eligibility Criteria
Inclusion Criteria:
- all patients aged 2-18 years
- Emergency Severity Index 2 to 5
- availability of completed computerized triage documentation.
Exclusion Criteria:
- critically ill patients (Emergency Severity Index 1)
- patients who leave-without-being seen
- patients who leave against-medical-advice
- patients whose final diagnosis was not asthma (false positive identification by the detection system) or were determined not to be eligible for the guideline.
Sites / Locations
- Vanderbilt Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Control
Arm Description
The control group will receive a paper-based printed asthma guideline.
Outcomes
Primary Outcome Measures
length of stay
Secondary Outcome Measures
guideline adherence
number of asthma scores
Full Information
NCT ID
NCT01070147
First Posted
February 10, 2010
Last Updated
August 15, 2018
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01070147
Brief Title
A Computerized Asthma Management System in the Pediatric Emergency Department
Official Title
A Computerized Asthma Management System in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
December 7, 2015 (Actual)
Study Completion Date
December 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of this study is that the combination of a computerized asthma reminder system with implementation of an guideline will increase utilization and adherence of guideline-driven care, leading to improved patient outcomes.
Hypothesis: An automatic, computerized reminder system for detecting asthma patients in the pediatric ED will increase guideline adherence compared to paper-based guideline.
The specific aims of the study are:
Aim 1: Develop, implement, and integrate the asthma guideline in the ED information system infrastructure.
Aim 2: Evaluate the effect of the asthma detection system combined with the computerized guideline versus the asthma detection system combined with the paper-based guideline.
Detailed Description
Asthma is the leading chronic childhood disease affecting 9 million children (12.5%) under 18 years of age (1). Asthma exacerbations cause an estimated 14 million missed school days (2) and more than 1.8 million emergency department (ED) visits annually (2), and account for >60% of asthma-related costs (3). The chronic characteristic of asthma carries a considerable economic burden.
Uncontrolled asthma can lead to exacerbations requiring the patient to seek immediate care, frequently in an ED setting. Several asthma guidelines, including the nationally accepted guideline from the National Heart, Lung, and Blood Institute (NHLBI), exist to support clinicians in providing adequate treatment. Utilization of and adherence with asthma guidelines improves patients' clinical care (4, 5). However, guideline adherence remains suboptimal. In the ED, early recognition and accurate assessment of the severity of airway obstruction and response to therapy are fundamental to the improvement of health for patients with asthma. The NHLBI guidelines emphasize early recognition and treatment of asthma exacerbations, as well as appropriate treatment stratified by severity.
Computer applications for patient care can address barriers to optimal medical care. Computer systems have improved the use and adherence to practice guidelines, provide clinical alerts and reminders, and generate patient-specific treatment recommendations and educational material. Implementation of guideline-driven decision support is frequently paper-based or computerized. In either form a major barrier remains on the busy clinicians to remember to initiate the guideline a process and to embed the guideline tasks in the clinical workflow of the care team (5). The proposed study examines the benefits of a novel approach for reminding clinicians in an ED setting to use guideline-driven care. The approach will apply a workflow-embedded process taking advantage of an advanced information technology infrastructure. The informatics approach will include two elements: a) a computerized, real-time reminder system, which will automatically detect guideline-eligible patients without requiring additional data entry, and b) a computerized, workflow-embedded guideline implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, emergency medicine, medical informatics, computerized reminder systems
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1631 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
The control group will receive a paper-based printed asthma guideline.
Intervention Type
Other
Intervention Name(s)
Computerized Asthma Management System
Intervention Description
The intervention group's clinicians will receive prompts via the computerized management system to prompt them for scoring, assessments, and disposition decisions.
Primary Outcome Measure Information:
Title
length of stay
Time Frame
48 hours (or patient discharged from emergency department)
Secondary Outcome Measure Information:
Title
guideline adherence
Time Frame
during ED visit (48 hours or less)
Title
number of asthma scores
Time Frame
during ED visit (48 hours or less)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients aged 2-18 years
Emergency Severity Index 2 to 5
availability of completed computerized triage documentation.
Exclusion Criteria:
critically ill patients (Emergency Severity Index 1)
patients who leave-without-being seen
patients who leave against-medical-advice
patients whose final diagnosis was not asthma (false positive identification by the detection system) or were determined not to be eligible for the guideline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith W Dexheimer, MS
Organizational Affiliation
Vanderbilt University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dominik Aronsky, MD, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Ref: QuickStats: Percentage of Children Aged <18 years Who Have Ever Had Asthma Diagnosed, by Age Group --- United States, 2003; MMWR April 29, 2005 / 54(16);412. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5416a5.htm
Results Reference
background
Citation
Allergy & Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.
Results Reference
background
PubMed Identifier
12613059
Citation
Grimshaw JM, Eccles MP, Walker AE, Thomas RE. Changing physicians' behavior: what works and thoughts on getting more things to work. J Contin Educ Health Prof. 2002 Fall;22(4):237-43. doi: 10.1002/chp.1340220408.
Results Reference
background
PubMed Identifier
1890276
Citation
Guidelines for the diagnosis and management of asthma. National Heart, Lung, and Blood Institute. National Asthma Education Program. Expert Panel Report. J Allergy Clin Immunol. 1991 Sep;88(3 Pt 2):425-534. No abstract available.
Results Reference
background
PubMed Identifier
11733292
Citation
Scribano PV, Lerer T, Kennedy D, Cloutier MM. Provider adherence to a clinical practice guideline for acute asthma in a pediatric emergency department. Acad Emerg Med. 2001 Dec;8(12):1147-52. doi: 10.1111/j.1553-2712.2001.tb01131.x.
Results Reference
background
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A Computerized Asthma Management System in the Pediatric Emergency Department
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