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

August 15, 2018 updated by: Vanderbilt University Medical Center

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

1102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 1 week after visit
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
Within 1 week after visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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