Patient Safety Learning Laboratory: Improving Safety of Diagnosis and Therapy in the Inpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Diagnostic error
研究概览
简要总结
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.
详细描述
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:
- 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.
- Design, develop, and iteratively refine intervention components using lessons learned from problem analysis and a participatory process that involves patients, clinicians, and institutional stakeholders.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Adult patients admitted to General Medicine Services at Brigham and Women's Hospital during the 21-months study data collection period
- •English speakers
- •Patients who were diagnosed with any of the following conditions and symptoms upon admission:
- •Abdominal pain
- •Altered mental status/ delirium / confusion
- •Asthma / chronic obstructive pulmonary disease (COPD)
- •Cellulitis / soft tissue infection
- •Chest pain
- •Deep vein thrombosis / pulmonary embolism / venous thromboembolism
- •Dyspnea / short of breath
- •Failure to thrive
- •Pneumonia
- •Protein-calorie malnutrition
- •Other conditions typical of general medicine patients
排除标准
- •Not pregnant women, prisoners and institutionalized individuals
研究组 & 干预措施
Control group
Patients do not have access to the Patient Dx Questionnaire.
干预措施: Diagnostic Uncertainty Educational Curriculum (Behavioral)
Control group
Patients do not have access to the Patient Dx Questionnaire.
干预措施: Diagnostic Timeout (Behavioral)
Control group
Patients do not have access to the Patient Dx Questionnaire.
干预措施: Enhancements to Epic-integrated Quality & Safety Dashboard (Behavioral)
Patient Dx Questionnaire User group
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
干预措施: Diagnostic Uncertainty Educational Curriculum (Behavioral)
Patient Dx Questionnaire User group
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
干预措施: Diagnostic Timeout (Behavioral)
Patient Dx Questionnaire User group
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
干预措施: Patient Diagnostic (Dx) Questionnaire (Behavioral)
Patient Dx Questionnaire User group
Patient enrollees will be randomized to receive the Patient Dx Questionnaire administered by the research staff at the bedside.
干预措施: Enhancements to Epic-integrated Quality & Safety Dashboard (Behavioral)
结局指标
主要结局
Diagnostic error
时间窗: 30 days (at most) from admission to the hospital
Data Source: Chart audit Analytic Variables: * % patients with diagnostic error * % patients with diagnostic error with actual or potential AE (i.e., harmful DE) * % patients with diagnostic error with actual or potential AE that was severe (i.e., harmful and severe DE) * % patients with diagnostic error with actual or potential AE that was preventable (i.e., harmful, severe, and preventable DE)
"Safe diagnosis"
时间窗: 30 days (at most) from admission to the hospital
Data Source: Chart audit Analytic variables: • % patients with correct diagnosis or therapy established within 24 hours of admission
次要结局
- Patient satisfaction(30 days after discharge from the hospital)
- Healthcare resource utilization(30 days after discharge from the hospital)
研究者
Anuj K. Dalal, MD
Associate Physician
Brigham and Women's Hospital