The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Stress- stimuli, experience, and responses are complex, as the judgment on whether a situation is perceived as pleasant or threatening depends on the individuals' appraisal, which is based: on previous experience; previous learning; the setting and expectations of the outcome. Stress stimuli arise when the appreciation of the situation is negative. Performers holding a strategy for their performance during stress are less prone to experience a stress sensation. Hence, the integration of a strategy for performing the procedure, based on the experts' process goals might benefit novices' risk of experiencing stress during procedure performance. The effect on such stress reduction to the patient experience of stress and the risks of procedure-related side effects has never been investigated.
The aim of this study is to investigate the effect of simulation-based training with mastery learning on novices' lumbar puncture performance, patient related outcomes and stress experienced by the physicians and patients during the procedure. The effect and outcomes will be compared with intermediate and expert lumbar puncture performers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Participants receive a 1.5-hour standardized simulation-based training course, with mastery learning. |
Other: Simulation-based training
See arm description
|
| No Intervention: Control Participants observe a procedure performed by a senior. |
Outcome Measures
Primary Outcome Measures
- Performance [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 before performance (Heart rate) [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 before performance (Power) [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 [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 before performance (pNN50) [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 (%)
- Doctors Heart Rate Variability during performance (Heart rate) [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 (Power) [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 during performance (RMSDD) [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 Heart Rate Variability during performance (pNN50) [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 State Trait Anxiety Inventory - Short [Five minutes before performance; Just Before Needle insertion;]
A questionaire exploring the stress related anxiety (scores range from 6-24)
- Doctors Cognitive Appraisal [Five minutes before performance]
Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)
Secondary Outcome Measures
- Patient Heart Rate Variability before performance [A recording of 5 minutes obtained five minutes before performance]
Heart Rate Variability: Heart rate (bp/min);
- Patient Heart Rate Variability during performance [A 5 minutes recording during procedure handling, just before obtaining liquor.]
Heart Rate Variability: Heart rate (bp/min);
- Patient Heart Rate Variability before performance [A recording of 5 minutes obtained five minutes before performance]
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
- Patient Heart Rate Variability during performance [A 5 minutes recording during procedure handling, just before obtaining liquor.]
Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated
- Patient Heart Rate Variability before performance [A recording of 5 minutes obtained five minutes before performance]
Heart Rate Variability: RMSDD (ms)
- Patient Heart Rate Variability during performance [A 5 minutes recording during procedure handling, just before obtaining liquor.]
Heart Rate Variability: RMSDD (ms)
- Patient Heart Rate Variability before performance [A recording of 5 minutes obtained five minutes before performance]
Heart Rate Variability: pNN50 (%)
- Patient Heart Rate Variability during performance [A 5 minutes recording during procedure handling, just before obtaining liquor.]
Heart Rate Variability: pNN50 (%)
- Patients State Trait Anxiety Inventory - Short [Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure]
A questionaire exploring the stress related anxiety (scores range from 6-24)
- Procedure outcomes [Registrered during procedure operation]
Number of needle insertions, Failing/abandoning the procedure performance (yes/no)
- Duration of time to needle insertion [Registrered during procedure operation, or evaluated using the videorecordings of the procedure]
Time from needle penetration of the skin to obtaining liquor (mm:ss)
- Confidence in operator [Five minutes after termination of the procedure]
A 10-point Likert scale: 0=not confident - 10=very confident
- Pain intensity during procedure [Five minutes after termination of the procedure]
A 10-point Likert scale; 0= no pain - 10= Worst imaginable pain.
- Post Dural Puncture Headache [Telephone interview seven days after the procedure performance date]
Post Dural Puncture Headache, using the Lübeckers classification
- Days of sickness leave [Telephone interview seven days after the procedure performance date]
Days sick leave related to procedure performance
Eligibility Criteria
Criteria
For the medical doctors randomized:
Inclusion Criteria:
-
MD, or Medical student working as substitute junior medical officer, or having clinical rotation at the study sites.
-
Speaking Danish fluently
Exclusion Criteria:
-
Previous Lumbar Puncture experience
-
Previous formal training in the lumbar puncture procedure
Eligible patients:
Inclusion criteria:
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Glasgow Coma Scale 15
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Referred to the outpatient clinic for a lumbar puncture.
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Proficiency in the Danish Language
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Age between 18 and 80 years
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Understand study implications and co-operate without a need for personal assistance.
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Providing written and orally informed consent
Exclusion criteria for patients:
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Lumbar puncture intended on suspicion of Alzheimer or other dementia diagnosis.
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Cognitive impairment, assessed by the study investigator or local nurse/doctor
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Physical disabilities, requiring personal assistance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, Rigshospitalet - Glostrup | Glostrup | Capital Region of Denmark | Denmark | 2600 |
| 2 | Department of Neuology, Herlev Hospital | Herlev | Capital Region of Denmark | Denmark | 2730 |
| 3 | Department of Neurology, University Hospital Zealand | Roskilde | Region Zealand | Denmark | 400 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- TrygFonden, Denmark
Investigators
- Principal Investigator: Mikael J Henriksen, MD, CAMES - Rigshospitalet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- StressLBP