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临床试验/NCT01869075
NCT01869075已完成不适用

Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 1,895 人开始时间: 2006年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,895
试验地点
2
主要终点
Percentage of Patients Prescribed Appropriate VTE Prophylaxis

研究概览

简要总结

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE, is one of the common and preventable complications of hospital stay. VTE prophylaxis through the use of evidence-based anticoagulant medication options or mechanical prophylaxis have been shown to reduce this risk and improve patient safety. Despite an abundance of evidence, use of VTE prophylaxis remains low.

This study assesses the effectiveness of quality improvement strategies (use of pre-printed orders, audit and feedback, involvement of the pharmacist as project need and as a reminder to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study aims to measure if the use of these strategies improves the use of VTE prophylaxis and therefore, improves patient safety and patient care by reducing the risk of developing DVT or PE.

详细描述

The study includes 8 Toronto area hospitals consisting of 7 community hospital and one academic health sciences centre.

Three patient groups at each site are included in the study: patients admitted for: Acute Medical Illness (AMI), Major General Surgery (MGS) and Hip Fracture Surgery (HFS). Patients had to be at least 18 years old and be considered at risk for VTE according to the American College of Chest Physicians (CHEST) guidelines.

The study design is a cluster randomized trial where each patient group at each site is a cluster.

A baseline chart audit of approximately 50 patients in each group at each site was conducted to determine an intraclass coefficient and proportion of adherence.

The main outcome measure was the rate of prescribing appropriate prophylaxis in patients at risk. This was calculated as the number of at risk patients receiving appropriate prophylaxis / the number of at risk patients for whom prophylaxis is indicated.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age at least 18 years
  • at risk for VTE

排除标准

  • on therapeutic anticoagulation

研究组 & 干预措施

AMI - Usual Care

No Intervention

Usual care

AMI - Knowledge Translation toolkit

Experimental

AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

干预措施: Knowledge Translation (KT) toolkit (Other)

MGS - Knowledge Translation Toolkit

Experimental

Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff

干预措施: Knowledge Translation (KT) toolkit (Other)

MGS - Usual Care

No Intervention

Usual Care

HFS - Knowledge Translation Toolkit

Experimental

Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

干预措施: Knowledge Translation (KT) toolkit (Other)

HFS - Usual Care

No Intervention

Usual Care

结局指标

主要结局

Percentage of Patients Prescribed Appropriate VTE Prophylaxis

时间窗: End of study (end of phase 2) - measured over duration of hospital stay.

Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk. Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control. Appropriate VTE prophylaxis was defined as: in "Hip Fracture Surgery" - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in "Major General Surgery" - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in "Acute Medical Illness" - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay. Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Artemis Diamantouros

KT Pharmacist

Sunnybrook Health Sciences Centre

研究点 (2)

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