A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00699439
First received: June 12, 2008
Last updated: August 19, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Asthma
Medical Informatics
Other: Paper-based asthma flow diagram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Reminder System for Paper-Based Asthma Guidelines in the Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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). [ Time Frame: Within 1 week after visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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.
Other: Paper-based asthma flow diagram
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.
No Intervention: B
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.
Other: Paper-based asthma flow diagram
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.

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

  1. 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
  2. Allergy & Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.
  3. 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.
  4. 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.
  5. 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.
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699439

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Judith W Dexheimer, MS Vanderbilt University
Principal Investigator: Dominik Aronsky, MD, PhD Vanderbilt University
Study Chair: Donald H Arnold, MD, MPH Vanderbilt University
  More Information

Publications:
Responsible Party: Judith Dexheimer, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00699439     History of Changes
Other Study ID Numbers: 070206
Study First Received: June 12, 2008
Last Updated: August 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Medical Informatics
Asthma
Emergency Service, Hospital
Bayesian Method

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014