WIse CHoices in the Intensive Care Unit, a Cluster Randomized Registry Based Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- 30-day mortality
研究概览
简要总结
Aim: to evaluate if the Choosing Wisely campaign can be introduced without harming critically ill patients.
Background: Each year, around 45,000 patients are admitted to Sweden's 81 ICUs (intensive care units), costing 6-7 billion SEK (6% of total healthcare expenditure). The high costs of health care are partly attributable to overuse of diagnostic tests. Up to 30% of these tests lead to treatments that provide no benefit for patients, some of them may even be harmful(1-3). To improve quality of care while combating this problem of cost, the American Board of Internal Medicine Foundation developed the Choosing Wisely Campaign, tasking professional societies to develop lists of top five medical services patients and physicians should question. Patients in the ICU, can especially benefit from this paradigm shift. They are subjected to multiple testing on a daily - sometimes hourly - basis, therefore this field of medicine responded to the campaign quickly. Two sets of top-five-lists of tests and interventions that can be questioned have been published(4 5).
In multiple countries, including Sweden, the Choosing Wisely campaign is gathering traction among critical care physicians and is on the verge of being introduced. It is both common-sensical and will save money, so health care leaders are positive. However, the investigators have an opportunity, and a duty, to assess the evidence; can the Choosing Wisely campaign be introduced without harming ICU patients?
The present study thus aims to evaluate the introduction of the Choosing Wisely campaign in the context of the ICU. Is this change of care strategy associated with changes in 30-day-mortality? Secondary outcomes include ICU length of stay, use of non-invasive- or invasive mechanical ventilation and continuous renal replacement therapy. This is a registry-based cluster randomized controlled study (R-RCT), targeting Swedish ICU's across multiple regions. Primary and secondary outcomes will be retrieved from the Swedish Intensive care Register (SIR), making ICU participation easier and less costly.
详细描述
Purpose and aims Aim: to evaluate if the Choosing Wisely campaign can be introduced without harming critically ill patients.
Background: Each year, around 45,000 patients are admitted to Sweden's 81 ICUs (intensive care units), costing 6-7 billion SEK (6% of total healthcare expenditure). The high costs of health care are partly attributable to overuse of diagnostic tests. Up to 30% of these tests lead to treatments that provide no benefit for patients, some of them may even be harmful. To improve quality of care while combating this problem of cost, the American Board of Internal Medicine Foundation developed the Choosing Wisely Campaign, tasking professional societies to develop lists of top five medical services patients and physicians should question. Patients in the ICU, can especially benefit from this paradigm shift. They are subjected to multiple testing on a daily - sometimes hourly - basis, therefore this field of medicine responded to the campaign quickly. Two sets of top-five-lists of tests and interventions that can be questioned have been published.
In multiple countries, including Sweden, the Choosing Wisely campaign is gathering traction among critical care physicians and is on the verge of being introduced. It is both common-sensical and will save money, so health care leaders are positive. However, the investigators have an opportunity, and a duty, to assess the evidence; can the Choosing Wisely campaign be introduced without harming ICU patients?
The present study thus aims to evaluate the introduction of the Choosing Wisely campaign in the context of the ICU. Is this change of care strategy associated with changes in 30-day-mortality? Secondary outcomes include ICU length of stay, use of non-invasive- or invasive mechanical ventilation and continuous renal replacement therapy as well as unplanned readmissions. This is a registry-based cluster randomized controlled study (R-RCT), targeting Swedish ICU's across multiple regions. Primary and secondary outcomes will be retrieved from the Swedish Intensive care Register (SIR), making ICU participation easier and less costly.
Survey of the field Investigations on mortality, ICU length of stay (LOS) or effect on organ support among critically ill patients after the introduction of the Choosing Wisely protocol are lacking. Evidence suggests that routine laboratory testing is associated with preventable harms, such as hospital-acquired anemia and further unnecessary testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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 or older, treated in Swedish ICU's
排除标准
- •Patients under the age of 18 years
研究组 & 干预措施
Choosing wisely intervention
The Choosing Wisely (CW) protocol in the critical care setting; specifically minimizing the number of arterial blood gases, number of venous tests and number of chest x-rays
干预措施: Choosing wisely protocol (Procedure)
Choosing wisely control
Regular critical care
结局指标
主要结局
30-day mortality
时间窗: 30 days after index ICU admission
Death within 30 days of ICU admission
次要结局
- ICU length of stay(Up to one year after index ICU admission)
- Time in invasive/ non-invasive mechanical ventilation(Up to one year after index ICU admission)
- Time on continuous renal replacement therapy(Up to one year after index ICU admission)
- ICU length of stay(Up to one year after index ICU admission)
- Time in invasive/ non-invasive mechanical ventilation(Up to one year after index ICU admission)
- Time on continuous renal replacement therapy(Up to one year after index ICU admission)
- ICU readmission(72 hours post ICU discharge)
研究者
Max Bell
MD, PhD
Karolinska Institutet
