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临床试验/NCT06119464
NCT06119464进行中(未招募)不适用

Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)

University of Calgary2 个研究点 分布在 1 个国家目标入组 251,817 人开始时间: 2023年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
251,817
试验地点
2
主要终点
Number of routine laboratory tests ordered per patient-day in the intervention versus control periods

研究概览

简要总结

Laboratory test overuse occurs when tests are ordered repetitively, without due consideration of impact on clinical status. Repetitive inpatient lab testing often provides limited value for patient outcomes while increasing healthcare costs, patient discomfort, and unnecessary transfusions and prolonging hospitalizations. The research study aims to reduce laboratory test overuse in hospitals through implementation of a comprehensive, multi-disciplinary, and multi-faceted intervention bundle that includes audit and feedback reports, clinician education, clinical decision support tool, and patient infographics across 14 hospitals in Alberta.

详细描述

Background: Laboratory and Pathology testing contributes to rising health care expenditure. A relatively large percentage (up to 42%) of laboratory testing can be considered wasteful. Redundant testing alone has been estimated to waste up to 5 billion dollars annually in the United States of America. Laboratory over-utilization leads to false positives that promotes further inappropriate testing and procedures, interruption of normal sleep pattern of inpatients, as well as iatrogenic anemia and pain. A Canadian study showed significant hemoglobin reductions as a result of phlebotomy. Studies support the safe reduction of repetitive laboratory testing without negative effects on adverse events, readmission rates, critical care utilization, or mortality.

The aim of this research study is the following:

  1. To implement a multimodal intervention bundle containing healthcare provider and patient engagement tools for hospitalized medical inpatients in 14 hospitals across the province of Alberta in Canada using a cluster randomized stepped-wedge design
  2. To evaluate the impact of the intervention bundle on laboratory test utilization of six target laboratory tests (complete blood count, electrolytes, creatinine, urea, partial thromboplastin time, and international normalized ratio), costs, and patient safety outcomes.

This intervention bundle will be implemented across all the adult hospital sites in Alberta starting January 2023 and evaluated until October 2024.

研究设计

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

  • all participants (patients and healthcare providers) within enrolled adult hospitals in Alberta of medical and hospitalist units during study period

排除标准

  • outside of the above-mentioned province
  • hospitals not enrolled
  • non-medical units (eg. ICU, surgical, pediatric, obstetrical units)

研究组 & 干预措施

Unexposed to intervention (control period)

No Intervention

This is the time period of the study where hospital clusters are not receiving the intervention

Exposed to intervention (intervention period)

Experimental

This is the time period of the study where hospital clusters are receiving the multimodal intervention.

干预措施: Multimodal Intervention: Education (Other)

Exposed to intervention (intervention period)

Experimental

This is the time period of the study where hospital clusters are receiving the multimodal intervention.

干预措施: Multimodal Intervention: Audit and Feedback (Other)

Exposed to intervention (intervention period)

Experimental

This is the time period of the study where hospital clusters are receiving the multimodal intervention.

干预措施: Multimodal Intervention: Patient Engagement (Other)

Exposed to intervention (intervention period)

Experimental

This is the time period of the study where hospital clusters are receiving the multimodal intervention.

干预措施: Multimodal Intervention: System Changes (Other)

结局指标

主要结局

Number of routine laboratory tests ordered per patient-day in the intervention versus control periods

时间窗: 1 year 9 months

Number of the six target laboratory tests (complete blood count, electrolytes, creatinine, urea, international normalized ratio and partial thromboplastin time) ordered per patient-day

次要结局

  • 30-day post discharge readmission rate(30 days post discharge)
  • Length of stay(1 year 9 months)
  • In-patient and 30-day patient mortality over study period(30 days post discharge)
  • Proportion of critically abnormal test results(1 year 9 months)
  • Transfer to Intensive Care Unit(1 year 9 months)
  • Costs associated with routine and all common laboratory test ordered(1 year 9 months)
  • Proportion of hospital patient lab-free days(1 year 9 months)
  • Number of all common laboratory tests(1 year 9 months)

研究者

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

Anshula Ambasta

Clinical Assistant Professor

University of Calgary

研究点 (2)

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