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临床试验/NCT00853463
NCT00853463已完成不适用

Multi-centered Discharge Alert to Prevent DVT and PE at Hospital Discharge

Brigham and Women's Hospital22 个研究点 分布在 1 个国家目标入组 2,515 人开始时间: 2009年4月1日最近更新:
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
2,515
试验地点
22
主要终点
Clinically diagnosed DVT and/or PE

研究概览

简要总结

Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other hospitals that focuses on whether physician notification prior to discharge of high risk VTE patients will reduce the incidence of VTE after hospital discharge.

详细描述

BACKGROUND INFORMATION AND RATIONALE FOR THE STUDY

Venous thromboembolism (VTE) is often avoidable in hospitalized patients because proven prevention strategies have been established for patients at risk (1). North American and European prophylaxis guidelines have been widely disseminated. However, despite focus on strategies for the prevention of VTE in hospitalized patients at the time of admission to the hospital, there has been little focus on prevention of VTE at the time of discharge from the hospital (2,3).

At Brigham and Women's Hospital, we undertook a previous Quality Improvement Initiative (BWH protocol # 2000P000328) aimed at increasing the frequency of VTE prophylaxis in high risk patients. This novel strategy required: 1) devising a risk score that reliably and quickly identified patients at high risk of VTE, and 2) randomizing high-risk patients without prophylaxis into an intervention group or control group. The intervention group's physicians received a single electronic, computerized alert explaining that the patient was at high risk, was not receiving prophylaxis, and suggesting that prophylaxis be ordered from a template of available pharmacological and mechanical options. In contrast, the control group's physicians received no alert (4).

Each of 8 common risk factors was weighted according to a point scale. To be labeled as "high-risk" for VTE, the point score must equal or exceed 4 points.

There were 2,506 patients in the Quality Improvement Initiative: 1,255 in the intervention group and 1,251 in the control group. The incidence of symptomatic VTE at 90 days was high: 8.2% in the control group and 4.9% in the intervention group (4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • •Patients > 18 years of age
  • •Planned discharge within 48 hours
  • •Cumulative VTE risk score at least 4
  • •Patients from Medical Services

排除标准

  • •VTE risk score <4
  • •Patients <18 years of age
  • •Full anticoagulation therapy planned upon discharge, i.e., atrial fibrillation, mechanical heart valve, venous thromboembolism treatment, etc.
  • •Patient is admitted to a non-medical service, i.e., surgical service, orthopedics, obstetrics/gynecology, neurology, psychiatry, or other non-medical service

研究组 & 干预措施

No Alert

No Intervention

The responsible physician of a patient randomized to the control arm will not be contacted regarding the increased VTE risk of the patient.

Alert

Other

The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders

干预措施: Alert (Behavioral)

结局指标

主要结局

Clinically diagnosed DVT and/or PE

时间窗: 90 days after discharge

次要结局

  • Mortality(30 and 90 days)
  • Hemorrhagic events(30 and 90 days)

研究者

申办方类型
Other

研究点 (22)

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