Improving Safety of Diagnosis and Therapy in the Inpatient Setting — PSLL2-0  

Asthma Clinical Trial

Official title: Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting

Status Completed

Clinical Trial Summary

To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.

Clinical Trial Description

The goal of this study is to improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients. The investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement, and implementation science to thoroughly analyze the problem, design and develop potential solutions that leverage the current technological infrastructure, and implement and evaluate the final interventions.

The aims of this study are to:

1. Analyze the problem of diagnostic error over the acute episode of care, identifying system and cognitive factors for a set of morbid, costly common conditions and undifferentiated symptoms by using system engineering and human factors methods, as well as electronic health record and administrative data review.

2. Design, develop, and iteratively refine intervention components using lessons learned from problem analysis and a participatory process that involves patients, clinicians, and institutional stakeholders.

3. Implement an intervention for patient and clinician subjects on general medicine units. Using a pre-post, interrupted time series study design, the investigators will evaluate the effect of the intervention primarily on diagnostic and therapeutic errors. The investigators will use mixed methods to understand barriers and facilitators of implementation. ;

Related Conditions & MeSH terms

• Abdominal Pain
• Asthma
• Back Pain
• Cellulitis
• Chest Pain
• Confusion
• COPD
• Cough
• Deep Vein Thrombosis
• Delirium
• Diarrhea
• Dyspnea
• Electrolyte Metabolism Abnormal
• Embolism
• Failure to Thrive
• Fever
• Headache
• Hip Pain Chronic
• Hypoxia
• Leg Pain
• Malnutrition
• Mental Status Change
• Neck Pain
• Pneumonia
• Protein-Calorie Malnutrition
• Protein-Energy Malnutrition
• Pulmonary Embolism
• Sepsis
• Soft Tissue Infections
• Syncope
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis
• Vomiting
• Weakness

• NCT number: NCT04393909
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Completion date: December 30, 2021