跳至主要内容
临床试验/NCT04187534
NCT04187534已完成不适用

Critical Care Optimization of Albumin Ordering

University of Calgary28 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2019年11月25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
50,000
试验地点
28
主要终点
Proportion of ICU admissions receiving albumin

研究概览

简要总结

Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported albumin use outside these circumstances as a quality improvement opportunity in Alberta ICUs. In 2017, the investigators began a pilot initiative to reduce albumin overuse in 6 ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework, and consisted of establishing a clinical champion, educating clinicians, changing the process for albumin ordering (albumin-specific order sheet), and providing quarterly audit/feedback data to clinicians on albumin utilization. During the intervention, there was a 41% relative reduction in albumin utilization. However, follow-up data identified problems with sustainability. These sustainability challenges combined with data suggesting high albumin use in other ICUs throughout Alberta have led the current project to build on the pilot initiative to reduce albumin overuse within all adult ICUs in Alberta.

The proposed quality improvement intervention will be implemented in 16 adult ICUs using a registry-based, stepped-wedge implementation design that will lean heavily on existing Provincial healthcare infrastructure. The intervention was developed using the Theoretical Domains Framework, and tailored to the unique features of each participating ICU. It will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period. To evaluate the quality improvement initiative, eCritical will serve as a 'registry' and will be used to capture all clinical and outcome data. The primary outcome will be the proportion of ICU admissions without an evidence-based indication for albumin, prescribed at least 1 unit of albumin (any concentration) during admission to ICU. 'Evidence-based indication' will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with spontaneous bacterial peritonitis or large volume ascitic fluid removal.

详细描述

BACKGROUND: Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported overuse of albumin fluid resuscitation as a stakeholder-identified quality improvement opportunity in Alberta ICUs. Audit data from the provincial electronic medical record (EMR) for critical care, eCritical, reinforced stakeholder opinion and demonstrated that within Alberta ICUs in 2016 a considerable amount of albumin use deviated from evidence-based indications. On average, 14% of admissions to adult ICUs received at least one albumin unit during their ICU admission, with several high-use units providing albumin to between 20% and 35% of admissions. In 2017 the investigators began a pilot quality improvement initiative to reduce albumin overuse in six ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework. Questionnaires completed by clinicians working in the target ICU identified local culture and opinion of clinical leaders as barriers, and education, order sets, and clinical champions as facilitators to reducing albumin use. The intervention thus consisted of establishing a clinical champion, educating clinicians, changing the process for albumin through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization. There was a 41% reduction in albumin utilization, however follow-up data identified problems with sustainability. The current project will build on the pilot initiative to implement a quality improvement intervention to reduce albumin overuse within all adult ICUs in Alberta.

OBJECTIVE: Evaluate albumin reduction within all adult ICUs in Alberta.

METHODS: This will be a registry-based, stepped-wedge quality improvement initiative.

Quality Improvement Initiative: Spread to 16 adult ICUs in Alberta will require understanding and adapting the investigators pilot intervention to local barriers and facilitators. The intervention for this quality improvement initiative will be developed using the Theoretical Domains Framework. The research team will develop working groups responsible for tailoring the intervention and implementation strategy to each participating ICU. This will be conducted as part of the Province-wide quality improvement initiative. The investigators will conduct the quality improvement initiative using a registry-based, stepped-wedge, implementation trial. Owing to the nature of this design, the interventions will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period.

Registry-based data analysis: To evaluate this quality improvement initiative, the Provincial EMR for critical care, eCritical, will serve as a 'registry' and will be used to capture all clinical and outcome data. Data will be collected until patient death or hospital discharge and censored at 60 days. To optimize efficiency and power, data will be collected 3-months before and after implementation of the interventions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • All adult patients admitted to the study ICUs

排除标准

  • 未提供

研究组 & 干预措施

Albumin Fluid Resuscitation Optimization Intervention

Experimental

Our quality improvement intervention seeking to improve appropriate use and reduce inappropriate use of albumin for fluid resuscitation will consist of establishing a clinical champion, educating clinicians, changing the process for albumin ordering through development of an albumin order sheet, and providing quarterly unit-level audit/feedback data to clinicians on albumin utilization.

干预措施: Albumin Fluid Resuscitation Optimization Intervention (Other)

Usual Practice

Active Comparator

Stepped-wedge roll out of 'Albumin Fluid Resuscitation Optimization Intervention' will permit those ICUs wherein intervention has not yet been implemented to serve as controls. These ICUs will prescribe albumin according to usual practice and not be exposed to any components of the intervention.

干预措施: Usual Practice (Other)

结局指标

主要结局

Proportion of ICU admissions receiving albumin

时间窗: During ICU admission

Proportion of ICU admissions without an evidence-based indication for albumin prescribed at least 1 unit of albumin (any concentration) during admission to ICU

次要结局

  • ICU length of stay(From date of ICU admission to date of discharge, on average 1-6 days)
  • Total crystalloid fluid(ICU Day 7)
  • Total fluid administration(ICU day 7)
  • Duration of vasopressor administration(From date of ICU admission to date of discharge, on average 1-6 days)
  • Mean number of albumin units among those receiving albumin(During ICU admission)
  • Hospital length of stay(From date of hospital admission to date of discharge, on average 5-20 days)
  • Length of mechanical ventilation(From date mechanical ventilation commended to date discontinued, on average 0-3 days)
  • ICU mortality(From date of ICU admission to date of discharge, on average 1-6 days)
  • Hospital mortality(From date of hospital admission to date of discharge, on average 5-20 days)

研究者

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

Daniel Niven

Assistant Professor

University of Calgary

研究点 (28)

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