- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01070147
A Computerized Asthma Management System in the Pediatric Emergency Department
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Control
The control group will receive a paper-based printed asthma guideline.
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The intervention group's clinicians will receive prompts via the computerized management system to prompt them for scoring, assessments, and disposition decisions.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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length of stay
Lasso di tempo: 48 hours (or patient discharged from emergency department)
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48 hours (or patient discharged from emergency department)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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guideline adherence
Lasso di tempo: during ED visit (48 hours or less)
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during ED visit (48 hours or less)
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number of asthma scores
Lasso di tempo: during ED visit (48 hours or less)
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during ED visit (48 hours or less)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Dominik Aronsky, MD, PhD, Vanderbilt University
- Direttore dello studio: Judith W Dexheimer, MS, Vanderbilt University
Pubblicazioni e link utili
Pubblicazioni generali
- 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 Fall;22(4):237-43. doi: 10.1002/chp.1340220408.
- 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 Dec;8(12):1147-52. doi: 10.1111/j.1553-2712.2001.tb01131.x.
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 100189
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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