The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Doctors Heart Rate Variability before performance
研究概览
简要总结
This study will investigate the effect of simulation-based training with mastery learning (SBML) on novice performers' lumbar puncture (LP) performance in a clinical setting. The study will investigate the effect on operators' performance, stress level, and on patient experienced stress, confidence in operator, and patient-related outcomes of pain, and risk of subsequent Post Dural Puncture Headache (PDPH), and days of sickness leave.
The study will compare the effect of the training to a control group of novices receiving standard training and additionally to an intermediate and an expert group.
The study will provide insight into the translational effect from the simulation based setting to clinical performance. Further, the study will explore: if stress decreases operators' performance; if operators stress affects the patient stress level; and the effect of SBML on patient-related outcomes.
详细描述
The lumbar puncture procedure is considered a complex procedure. Junior doctors hold uncertainties in performing the procedure and perform below stakeholders expectations. This conflicts with the potential need for immediate performance on critical patients.
The traditional training for junior physicians has been guided by the expectation that experience will lead to mastery. This assumption has been disproved by simulation based and observational studies calling for more educational research including its impact on patient outcomes. A contrast to the maxim of "see one, do one, teach one" is mastery learning (ML). ML implies that learners should practice and re-test until they reach a designated mastery level, making the final level the same for all, although the time taken to reach that level may vary.
Novices trained by simulation based training with mastery learning (SBML) achieve a higher performance level than more experienced physicians only having received clinical training. However, the translational effect into the clinical context is unknown as the training and assessment of competence was performed in the simulation based setting, not integrating aspects as patient communication and positioning. For the lumbar puncture, the complexity of the procedure pertains to both technical and non-technical aspects as patient interaction, communication, the corporation with the assistant and environmental conditions.
Hence, there is a need for more knowledge on the effect of simulation-based training with mastery learning for junior doctors' performance in the clinical setting which should include the effect on patient-related outcomes.
As novices describe a fear of doing harm and hold performance related uncertainty, they may be susceptible to experience a stress sensation. Stress during performance of clinical procedures reduces the working memory and is associated with impaired performance. Expert performers' reports that stress during the procedure performance might be transmitted to the patient. Patients experiencing stress during the procedure holds a significantly increased risk of a prolonged duration of post dural puncture headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MD, or Medical student working as substitute junior medical officer, or having clinical rotation at the study sites.
- •Speaking Danish fluently
排除标准
- •Previous Lumbar Puncture experience
- •Previous formal training in the lumbar puncture procedure
- •Eligible patients:
- •Inclusion criteria:
- •Glasgow Coma Scale 15
- •Referred to the outpatient clinic for a lumbar puncture.
- •Proficiency in the Danish Language
- •Age between 18 and 80 years
- •Understand study implications and co-operate without a need for personal assistance.
- •Providing written and orally informed consent
- •Exclusion criteria for patients:
- •Lumbar puncture intended on suspicion of Alzheimer or other dementia diagnosis.
- •Cognitive impairment, assessed by the study investigator or local nurse/doctor
- •Physical disabilities, requiring personal assistance.
结局指标
主要结局
Doctors Heart Rate Variability before performance
时间窗: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: RMSDD (ms)
Doctors Heart Rate Variability during performance (Power)
时间窗: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Doctors Heart Rate Variability before performance (Heart rate)
时间窗: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Heart rate (bp/min);
Doctors Heart Rate Variability during performance (pNN50)
时间窗: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: pNN50 (%)
Doctors Heart Rate Variability before performance (Power)
时间窗: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
Doctors Heart Rate Variability before performance (pNN50)
时间窗: A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: pNN50 (%)
Performance
时间窗: Videos will be recorded at time of lumbar puncture performance, for subsequent ratings within 3 months.
Performance of the procedure assessed by the Lumbar Puncture Assessment Tool (LumPAT)
Doctors Heart Rate Variability during performance (Heart rate)
时间窗: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: Heart rate (bp/min);
Doctors Heart Rate Variability during performance (RMSDD)
时间窗: A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Heart Rate Variability: RMSDD (ms)
Doctors State Trait Anxiety Inventory - Short
时间窗: Five minutes before performance; Just Before Needle insertion;
A questionaire exploring the stress related anxiety (scores range from 6-24)
Doctors Cognitive Appraisal
时间窗: Five minutes before performance
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
次要结局
- Duration of time to needle insertion(Registrered during procedure operation, or evaluated using the videorecordings of the procedure)
- Post Dural Puncture Headache(Telephone interview seven days after the procedure performance date)
- Procedure outcomes(Registrered during procedure operation)
- Patients State Trait Anxiety Inventory - Short(Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure)
- Confidence in operator(Five minutes after termination of the procedure)
- Pain intensity during procedure(Five minutes after termination of the procedure)
- Days of sickness leave(Telephone interview seven days after the procedure performance date)
- Patient Heart Rate Variability before performance(A recording of 5 minutes obtained five minutes before performance)
- Patient Heart Rate Variability during performance(A 5 minutes recording during procedure handling, just before obtaining liquor.)
研究者
Mikael Johannes Vuokko Henriksen
Principal Investigator, MD
Rigshospitalet, Denmark