A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
Primary Purpose
Asthma, Medical Informatics
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paper-based asthma flow diagram
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Medical Informatics, Asthma, Emergency Service, Hospital, Bayesian Method
Eligibility Criteria
Inclusion Criteria:
The study's inclusion criteria are:
- All patients aged 2-18 years;
- Emergency Severity Index 2 to 5; AND
- Availability of completed computerized triage documentation.
Exclusion Criteria:
The exclusion criteria are:
- 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 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
If a patient is identified as having an asthma exacerbation by the Bayesian Network, the paper-based flow-chart will be printed out to place on the chart.
If a patient is identified as having an asthma exacerbation by the Bayesian Network, and assigned to the control group, no flow-chart will be printed out.
Outcomes
Primary Outcome Measures
Guideline utilization. Guideline utilization will be defined as having used the guideline for the documentation of at least one assessment (asthma score).
Guideline Adherence. The measurement of guideline adherence includes three measures: a) asthma assessment (score); b) treatment compatible with assessment (or documentation of reason to deviate); and c) adherence to guideline schedule.
Secondary Outcome Measures
Full Information
NCT ID
NCT00699439
First Posted
June 12, 2008
Last Updated
August 15, 2018
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00699439
Brief Title
A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
Official Title
A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 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 idea is that the use of a computerized reminder system to help with the guideline implementation will increase utilization and adherence of guideline-driven care, leading to improved patient outcomes. The hypothesis we aim to address is that an automatic, computerized reminder system for detecting asthma patients in the pediatric ED will increase paper-based guideline utilization compared to paper-based guideline without the system.
We aim to implement a real-time, computerized asthma detection system and integrate the system with the pediatric emergency department information system, and evaluate the effect of the asthma detection system on reminding clinicians to use the paper-based asthma 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.
References
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
Allergy & Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.
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;22:237-243.
National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the diagnosis and management of asthma. 1997.
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;8:1147-1152.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Medical Informatics
Keywords
Medical Informatics, Asthma, Emergency Service, Hospital, Bayesian Method
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
If a patient is identified as having an asthma exacerbation by the Bayesian Network, the paper-based flow-chart will be printed out to place on the chart.
Arm Title
B
Arm Type
No Intervention
Arm Description
If a patient is identified as having an asthma exacerbation by the Bayesian Network, and assigned to the control group, no flow-chart will be printed out.
Intervention Type
Other
Intervention Name(s)
Paper-based asthma flow diagram
Intervention Description
If a patient is identified as having an asthma exacerbation by the Bayesian Network, the patients will be randomized to either arm A or B. If in A, the paper-based flow-chart will be printed out to place on the chart.
Primary Outcome Measure Information:
Title
Guideline utilization. Guideline utilization will be defined as having used the guideline for the documentation of at least one assessment (asthma score).
Time Frame
Within 1 week after visit
Title
Guideline Adherence. The measurement of guideline adherence includes three measures: a) asthma assessment (score); b) treatment compatible with assessment (or documentation of reason to deviate); and c) adherence to guideline schedule.
Time Frame
Within 1 week after visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The study's inclusion criteria are:
All patients aged 2-18 years;
Emergency Severity Index 2 to 5; AND
Availability of completed computerized triage documentation.
Exclusion Criteria:
The exclusion criteria are:
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
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominik Aronsky, MD, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald H Arnold, MD, MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17911842
Citation
Dexheimer JW, Brown LE, Leegon J, Aronsky D. Comparing decision support methodologies for identifying asthma exacerbations. Stud Health Technol Inform. 2007;129(Pt 2):880-4.
Results Reference
background
PubMed Identifier
17238704
Citation
Sanders DL, Aronsky D. Prospective evaluation of a Bayesian Network for detecting asthma exacerbations in a Pediatric Emergency Department. AMIA Annu Symp Proc. 2006;2006:1085.
Results Reference
background
PubMed Identifier
17238428
Citation
Sanders DL, Aronsky D. Detecting asthma exacerbations in a pediatric emergency department using a Bayesian network. AMIA Annu Symp Proc. 2006;2006:684-8.
Results Reference
background
PubMed Identifier
16647876
Citation
Sanders DL, Gregg W, Aronsky D. Identifying asthma exacerbations in a pediatric emergency department: a feasibility study. Int J Med Inform. 2007 Jul;76(7):557-64. doi: 10.1016/j.ijmedinf.2006.03.003. Epub 2006 May 2.
Results Reference
background
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A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department
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