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临床试验/NCT03564314
NCT03564314已完成不适用

Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

University of Calgary8 个研究点 分布在 1 个国家目标入组 2,135 人开始时间: 2018年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,135
试验地点
8
主要终点
Progression of AKI

研究概览

简要总结

Acute kidney injury (AKI) is common and costly complication of major surgery. AKI can lead to prolonged hospitalization and a higher likelihood of dialysis, chronic kidney disease and death. However, AKI can be reversed when recognized early, by ensuring that patients receive adequate fluids and medications that worsen kidney function or cause toxicity are avoided or appropriately prescribed. Past research suggests that AKI in surgical settings can be missed early in its onset, leading to delayed intervention and progression to more severe stages. The purpose of this project is to implement clinical decision support for early recognition and management of AKI on surgical units in Alberta hospitals, and to determine whether the initiative leads to improvements in the quality of care for AKI, length of hospital stay for patients, and costs to the healthcare system.

详细描述

Overview: Cluster-randomized stepped-wedge trial to evaluate the impact of implementing a clinical decision support initiative for early recognition and management of hospital-acquired AKI.

Study Population: Adult patients hospitalized on surgical units in Alberta who develop acute kidney injury will be eligible if not already receiving dialysis.

Intervention: The multidimensional clinical decision support intervention consists of: (1) electronic and non-computerized tools for early recognition of AKI, (2) educational program for clinical staff, (3) decision support resources and guidance for the management of AKI and consultation with specialists.

Study Design: Using a stepped-wedge design, eight general and vascular surgery unit clusters in Calgary (Foothills Medical Centre, Peter Lougheed Centre) and Edmonton (University of Alberta Hospital, Grey Nuns Community Hospital), Alberta will be randomly ordered to be sequentially introduced to the clinical decision support intervention. The pre-implementation period will include all patients admitted to the participating hospital units in the year before the random timing of introduction of the initiative on each participating unit. The post-implementation study cohort will include patients admitted in the year after the random timing of introduction of the initiative on each unit. Analysis of processes of care and outcomes will focus on patients on these units who develop AKI during the pre- and post-implementation time periods (i.e. are eligible to receive care under the AKI decision support initiative). Additionally, health care providers (e.g. physicians, nursing staff, pharmacists) who have direct experience with the clinical decision support tools and processes will be invited to participate in the surveys and interviews pre- and post-implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
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

入选标准

  • Adult patients (18 years of age and older) who develop hospital-acquired acute kidney injury on identified general and vascular surgery units in Alberta

排除标准

  • Hospitalized on non-surgical units
  • Receiving dialysis prior to admission on surgery unit

结局指标

主要结局

Progression of AKI

时间窗: From date of AKI onset to discharge from hospital, assessed up to 30 days

Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)

次要结局

  • Time to initial response to AKI(From AKI onset up to 48 hours following AKI onset)
  • Mortality(Within 30 days of AKI onset)
  • Volume intervention (change in fluid or diuretic order) for AKI(Within 48 hours following AKI onset)
  • Length of AKI hospital stay, days(From date of AKI onset to discharge from hospital, assessed up to 30 days)
  • Resource use for AKI(Duration of index hospital admission, assessed up to 30 days)
  • Adverse medication exposure(Within 48 hours following AKI onset)
  • Medical consultation for AKI(Within 7 days of AKI onset)
  • Change in estimated Glomerular Filtration Rate (eGFR)(From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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