跳至主要内容
临床试验/NCT03812861
NCT03812861已完成不适用

Cognitive Aids for the Management of Deteriorating Surgical Patients

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月7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
试验地点
2
主要终点
Failure to adhear to best practice (percentage of omitted critical management steps) for the given scenario

研究概览

简要总结

Background and Goal of Study: Adherence to best practice management of emergencies improves through the use of cognitive aids. Aim of this study was to develop and validate cognitive aids for management of deteriorating surgical ward patients (CAMDS) in order to improve adherence to best practice and hereby reduce the likelihood of failure to rescue.

Materials and Methods: Fifty surgical teams will be randomly assigned to manage 150 standardised high fidelity simulation cases of deteriorating patients using the CAMDS or not. There are 10 standardised patient scenarios; pneumonia, pneumothorax, bradycardia, cardiac arrest shockable and non-shockable rhythm, bleeding, myocardial infarction, anaphylaxis, sepsis and loss of consciousness. Two independent observers will score the team's performance in adhering to all the management steps. To assess perceived usability of the CAMDS participants will be asked about eight aspects of the CAMDS. These items will be scored on a Likert scale (0= strongly disagree to 4= strongly agree).

详细描述

INTRODUCTION AND RATIONALE

The suboptimal management of deteriorating surgical patients is an important factor in preventable death and morbidity in hospitals. Several studies have shown that the mortality rate in different hospitals is not associated with different complication rates between these hospitals but with the ability to effectively rescue patients from these complications. This has been called failure to rescue. Misapplication of the early warning score, failure to recognize a deteriorating patient, delays in seeking senior advice and delays in adequate management or inadequate resuscitation are found to be important factors. Strategies focusing on the management of complications once they occur may be essential to improve outcomes.

Recent publications emphasized human factors as a cause that contributed towards failure to rescue. Medical staff often fails to recognize a deteriorating patient. Partly because there is lack of insight in the development of a critically illness. Ludikhuize showed that care-providers mostly rate their care, provided to patients in the hours preceding a life-threatening adverse event, as good. However, independent experts felt that patients often could have been identified as deteriorating, much earlier. It does not, however, seem wholly unexpected that the assessment of a deteriorating patient by an experienced ICU consultant is superior to the assessment made by a ward nurse or junior surgical doctor.

Another important cause of failure to rescue was the failure to react promptly tot a deterioration in care. It has been reported that the Rapid Response Team (RRT) was called in only 30% of cases when criteria for activating the RRT were fulfilled. Sometimes because of an unclear escalation policy, sometimes because of self-doubt and insecurity of the care provider or because of hierarchical barriers.

It is known that the management of intraoperative emergencies improves through the use of cognitive aids.These cognitive aids remind practitioners to best practice management of these emergencies and hereby increase adherence to these practices. Because the CAMDS will assist surgical staff at the bedside in the assessment of deteriorating surgical patients and prompt best practice management of specific complications it is likely that failure to rescue will also decrease. The CAMDS can furthermore prompt a nurse or junior doctor to liaise with seniors and/or critical care staff. Because they can communicate a differential diagnosis and management steps taken so far from the CAMDS this might decrease self-doubt and insecurity in liaising with seniors or critical care staff. A, clear escalation policy on the CAMDS, embraced by the hospital can further assist in the timely escalation of care and breakdown of hierarchical barriers. This will result in a decrease of the likelihood of failure to rescue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Study introduction and familiarisation of the simulation lab and cognitive aid bundle will be done blindly for both participant and study staff. Randomisation will be done after study introduction and familiarisation of the simulation lab and cognitive aid bundle by means of opening a opaque sealed envelope. The randomisation is done by a computer generated code for use of the CAMDS (intervention) or not (control) and 3 patient scenario's

入排标准

性别
All
接受健康志愿者

入选标准

  • All hospital surgical staff is eligible

排除标准

  • Surgical staff that is unwilling to give consent
  • Staff that already has participated in the study

研究组 & 干预措施

CAMDS bundle

Experimental

25 surgical teams will manage 10 standardised simulated deteriorating ward patients with the help of a cognitive aid bundle

干预措施: CAMDS bundle (Other)

No bundle

No Intervention

25 surgical teams will manage 10 standardised simulated deteriorating ward patients without the help of a cognitive aid bundle

结局指标

主要结局

Failure to adhear to best practice (percentage of omitted critical management steps) for the given scenario

时间窗: start to end of high fidelity simulation session (aprox. 10 min)

Every scenario consisted of 15 predefined critical management steps (for examle cardiac arrest with a shockable rhythm critical steps would be; start basic life support, open the airway, identify shockable rhythm, defibrillate with appropriate amount of Joules etc.) Primary outcome is the failure to adhear to best practice expressed as percentage of omitted predefined critical management steps.

次要结局

  • Perceived usability of the CAMDS(During debrief of high fidelity simulation session (aprox. 30 min))

研究者

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

B Preckel

Principle Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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