A Computerized Asthma Management System in the Pediatric Emergency Department

NCT ID: NCT01070147

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

The control group will receive a paper-based printed asthma guideline.

Group Type EXPERIMENTAL

Computerized Asthma Management System

Intervention Type OTHER

The intervention group's clinicians will receive prompts via the computerized management system to prompt them for scoring, assessments, and disposition decisions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Computerized Asthma Management System

The intervention group's clinicians will receive prompts via the computerized management system to prompt them for scoring, assessments, and disposition decisions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith W Dexheimer, MS

Role: STUDY_DIRECTOR

Vanderbilt University

Dominik Aronsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

Allergy & Asthma Advocate. Quarterly patient newsletter of the American Academy of Allergy, Asthma and immunology. 2004.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12613059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1890276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11733292 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

100189

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eliminating Monitor Overuse Trial (EMO Trial)
NCT05132322 ACTIVE_NOT_RECRUITING NA
Towards Digital Management of Paediatric Asthma
NCT06902766 NOT_YET_RECRUITING NA