The emergency department triage of community-acquired pneumonia project data and documentation systems: a model for multicenter clinical trials.

Multicenter clinical trials are complex undertakings that require significant resources to ensure efficient, high quality research. This paper describes the goals, design, and implementation of a multicenter clinical trial database management system to support this aim. A large number of study sites or patients, and the goal of automatically generating large portions of data management infrastructure from common metadata, motivated the development of the system. This paper also describes extensions for a generalized project documentation system, and discusses plans for further extensions and improvements based on observed strengths, limitations, and anticipated technological change.

The emergency department community-acquired pneumonia trial: Methodology of a quality improvement intervention.

Community-acquired pneumonia causes more than 4 million episodes of illness each year and has high morbidity, mortality, and total cost of care. Nationwide, nearly 75% of community-acquired pneumonia patients are initially evaluated and treated in hospital-based emergency departments (EDs). Substantial variation exists in illness severity assessment, hospital admission decisions, and performance of recommended processes of care. We designed an ED-based quality improvement trial focused on the initial care of patients with community-acquired pneumonia. We used the Pneumonia Severity Index and level of arterial oxygenation to identify patients at low risk for 30-day mortality and to guide admission decisionmaking. We assessed the performance of recommended "best practices," consisting of assessment of arterial oxygenation, the collection of blood cultures for inpatients, and the timely initiation of appropriate empiric antibiotic therapy for inpatients and outpatients. We conducted a 32-site, cluster-randomized trial in Pennsylvania and Connecticut, comparing the effectiveness and safety of 3 guideline implementation strategies of increasing intensity. The multifaceted implementation plans were carried out in conjunction with each state's quality improvement organization. This article describes the background, objectives, and methodology of this trial to translate evidence-based knowledge on the quality and efficiency of care for community-acquired pneumonia into clinical practice.