Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,000
- 试验地点
- 2
- 主要终点
- Clinical Outcomes: Proportion of hospitalizations with any adverse event
研究概览
简要总结
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.
详细描述
The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) will develop systems approaches to integrating health information technology (HIT), stakeholder engagement mechanisms, and process design/engineering methods focused on patient safety, development and enhancement of tools, health care system interventions, and translation into practice. The three technological toolkits to be developed as part of the Patient Safety Learning Laboratory (PSLL) are:1) Patient-centered Fall Prevention Toolkit which aims to engage patients and their family caregivers in the design of HIT tools to prevent patient falls and related injuries during an acute hospitalization; 2) Patient Safety Checklist Tool to improve patient safety and quality outcomes, provider efficiency, and team communication; and 3) MySafeCare Patient Safety Reporting System which aims to iteratively develop and evaluate the impact of a patient safety reporting system on patient safety and fosters a health system focused on collaborative learning. The Brigham and Women's Patient Safety Learning Laboratory (BWH PSLL) will establish a vibrant learning ecosystem of health services, informatics, and systems engineering researchers, collaborating with patients and family for evolving and applying these approaches to adverse event prevention in hospitalized patients. In addition, a Systems Engineering, Usability, and Integration (SEUI) Core will leverage health systems engineering approaches to develop and provide a system-wide methodology to aid in the successful implementation and improvement of Health Information Technology (HIT) tools and a model known as the Patient SatisfActive® will be developed, tested, and refined to create a culture of patient- and family-centered care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 18-99 years of age
排除标准
- •patients under age 18 years
研究组 & 干预措施
Intervention
Patients and providers on hospital care units where the PSLL patient safety health information technology tools are implemented, during the interventional phase of a stepped wedge randomized trial design.
干预措施: Patient Safety health information technology (Behavioral)
Usual Care
Patients on hospital care units where the PSLL patient safety health information technology tools have been implemented or are to be implemented, but are not during the usual care phase of a stepped wedge randomized trial design.
结局指标
主要结局
Clinical Outcomes: Proportion of hospitalizations with any adverse event
时间窗: up to 21 months
Hospitalizations with the presence of any of the following: Patient Falls with Injury, Severe Hypoglycemia, Inpatient or post hospitalization venous thromboembolism, catheter associated urinary tract infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), Opioid related severe adverse drug event, hospital acquired pressure ulcer, severe hospital acquired delirium, rapid response related to arrhythmia
次要结局
- Clinical Inertia: When Red flag, % changed to yellow or green during hospitalization(up to 21 months)
- Clinical Inertia:When Red flag, % changed to green during hospitalization(up to 21 months)
- Patient Falls/ Mobility: % patient days of patients at fall risk due to a gait disturbance on sedatives(up to 21 months)
- Nutrition: % pt-days NPO with insulin aspart ordered at same time(up to 21 months)
- Venous thromboembolism (VTE): % pt-days with appropriate prophylaxis ordered based on risk and contraindications(up to 21 months)
- Antibiotic Management: % pt-days with pts on broad-spectrum antibiotics for > 72 hours(up to 21 months)
- Clinical Inertia: Mean time to resolution of red flags (to green or yellow), days(up to 21 months)
- Clinical Inertia:Mean time to resolution of red flags (to green), days(up to 21 months)
- Patient Falls/ Mobility:% pt-days of patients at fall risk due to a gait disturbance without Physical Therapy consult order(up to 21 months)
- Code Status: % patient-days on study unit with unconfirmed code status(up to 21 months)
- Glucose Control: % patients with diabetes or hyperglycemia with order for basal insulin(up to 21 months)
- Nutrition: % patient-days without any diet order(up to 21 months)
- Venous thromboembolism (VTE): % ordered pharmacologic prophylaxis doses administered(up to 21 months)
- Pain Control: % pt-days with MED > 100 mg(up to 21 months)
- Glucose Control: % patients with diabetes or hyperglycemia with orders for basal and nutritional insulin(up to 21 months)
- Venous thromboembolism (VTE):% pt-days with appropriate prophylaxis administered based on risk and contraindications(up to 21 months)
- Pain Control: % patient-days with opioids ordered and no adjunctive medications ordered(up to 21 months)
- Pain Control:% pt-days with opioids administered and no Richmond Agitation-Sedation Scale (RASS) score recorded(up to 21 months)
- Antibiotic Management: % patient-days with patients on broad-spectrum gram-positive and broad-spectrum gram-negative antibiotics for > 72 hours(up to 21 months)
- Delirium Management: % patient-days Confusion Assessment Method (CAM) positive(up to 21 months)
- Fall / Mobility: Patient Falls based on safety reports per 1000 patient-days(up to 21 months)
- Fall / Mobility: Falls with injury based on safety reports per 1000 patient-days(up to 21 months)
- Glucose Control: Patient-day-weighted mean glucose(up to 21 months)
- Delirium Management: % patient-days of patients at high risk for delirium on sedatives(up to 21 months)
- Delirium Management: % patient-days of patients at high risk for delirium on ramelteon(up to 21 months)
- Delirium Management: % patient-days of patients with hyperactive delirium on neuroleptics(up to 21 months)
- Vascular Access: % patient-days with central line in place(up to 21 months)
- Foley Care: % patient-days with Foley catheter in place(up to 21 months)
- Foley Care: % patient-days with Foley documented but not ordered(up to 21 months)
- Foley Care: % patient-days with Foley documented but Nurse Driven Protocol (NDP) not ordered(up to 21 months)
- Telemetry: % patient-days of high risk patients without any telemetry(up to 21 months)
- Telemetry: % patient-days of low risk patients on telemetry > 72h(up to 21 months)
- Bowel Regimen: % pt-days of patients on opioids and no bowel regimen ordered(up to 21 months)
- Glucose Control: Proportion of glucose readings 70-180 mg/dL, mean per patient(up to 21 months)
- Glucose Control: Proportion of patient-days with hypoglycemia(up to 21 months)
- Venous Thromboembolism: proportion of hospitalizations with VTE within 30 days of discharge(up to 21 months)
- Pain Control: proportion of hospitalizations with opioid induced depression of consciousness or respiration(up to 21 months)
- Pain Control: proportion of hospitalizations of patients on opioids who required narcan(up to 21 months)
- Bowel Regimen:% patient-days where on opioids, no bowel movement 2 or more days, and no bowel regimen administered(up to 21 months)
- Glucose Control: Proportion of patient-days with severe hypoglycemia(up to 21 months)
- Pain Control: proportion of hospitalizations of patients on opioids with any opioid-related Adverse Drug Event(up to 21 months)
- Venous Thromboembolism: proportion of hospitalizations with hospital-acquired VTE(up to 21 months)
- Pain Control: proportion of hospitalizations with severe opioid-related adverse drug event(up to 21 months)
- Pressure Ulcers: proportion of hospitalizations with hospital-acquired pressure ulcer(up to 21 months)
- Pressure Ulcers: proportion of hospitalizations with pressure ulcer worsening in stage from admission to discharge(up to 21 months)
- Foley Care: Central Line Associate Urinary Tract Infection per 1000 patient-days(up to 21 months)
- Delirium Management: proportion of hospitalizations requiring code gray and requiring security(up to 21 months)
- Delirium Management: proportion of hospitalizations requiring mechanical restraints(up to 21 months)
- Vascular Access: Central Line Associated Blood Stream Infection (CLABSI) per 1000 patient-days(up to 21 months)
- Telemetry: proportion of hospitalizations for rapid response for arrhythmia(up to 21 months)
研究者
David W. Bates, MD, MSc
Senior Vice President and Chief Innovation Officer
Brigham and Women's Hospital