The Effect of Simulation-Based Training on Performance and Stress in the Clinical Setting

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.

Study Overview

• Status: Unknown
• Conditions: Stress, Emotional; Spinal Puncture Complications; Simulation-based Training
• Intervention / Treatment: Other: Simulation-based training

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region of Denmark
    • Glostrup, Capital Region of Denmark, Denmark, 2600
      • Department of Neurology, Rigshospitalet - Glostrup
    • Herlev, Capital Region of Denmark, Denmark, 2730
      • Department of Neuology, Herlev Hospital
  • Region Zealand
    • Roskilde, Region Zealand, Denmark, 400
      • Department of Neurology, University Hospital Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Performance of the procedure assessed by the Lumbar Puncture Assessment Tool (LumPAT)	Videos will be recorded at time of lumbar puncture performance, for subsequent ratings within 3 months.
Doctors Heart Rate Variability before performance (Heart rate)	Heart Rate Variability: Heart rate (bp/min);	A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance (Power)	Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated	A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance	Heart Rate Variability: RMSDD (ms)	A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability before performance (pNN50)	Heart Rate Variability: pNN50 (%)	A recording of 5 minutes obtainted five minutes before performance, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (Heart rate)	Heart Rate Variability: Heart rate (bp/min);	A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (Power)	Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated	A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (RMSDD)	Heart Rate Variability: RMSDD (ms)	A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors Heart Rate Variability during performance (pNN50)	Heart Rate Variability: pNN50 (%)	A recording of 5 minutes obtainted five minutes before obtaining liquor, is compared to a rest-state recording after the procedure performance
Doctors State Trait Anxiety Inventory - Short	A questionaire exploring the stress related anxiety (scores range from 6-24)	Five minutes before performance; Just Before Needle insertion;
Doctors Cognitive Appraisal	Cognitive Appraisal explores the individuals perception of resources and demands for the performance (scores range from 1/6 to 6)	Five minutes before performance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Heart Rate Variability before performance	Heart Rate Variability: Heart rate (bp/min);	A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance	Heart Rate Variability: Heart rate (bp/min);	A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance	Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated	A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance	Heart Rate Variability: Power of Low Frequency, Very Low frequency, High Frequency (ms), a ratio of LF/HF will be calculated	A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance	Heart Rate Variability: RMSDD (ms)	A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance	Heart Rate Variability: RMSDD (ms)	A 5 minutes recording during procedure handling, just before obtaining liquor.
Patient Heart Rate Variability before performance	Heart Rate Variability: pNN50 (%)	A recording of 5 minutes obtained five minutes before performance
Patient Heart Rate Variability during performance	Heart Rate Variability: pNN50 (%)	A 5 minutes recording during procedure handling, just before obtaining liquor.
Patients State Trait Anxiety Inventory - Short	A questionaire exploring the stress related anxiety (scores range from 6-24)	Five minutes before performance; Just Before Needle insertion; Five minutes after termination of the procedure
Procedure outcomes	Number of needle insertions, Failing/abandoning the procedure performance (yes/no)	Registrered during procedure operation
Duration of time to needle insertion	Time from needle penetration of the skin to obtaining liquor (mm:ss)	Registrered during procedure operation, or evaluated using the videorecordings of the procedure
Confidence in operator	A 10-point Likert scale: 0=not confident - 10=very confident	Five minutes after termination of the procedure
Pain intensity during procedure	A 10-point Likert scale; 0= no pain - 10= Worst imaginable pain.	Five minutes after termination of the procedure
Post Dural Puncture Headache	Post Dural Puncture Headache, using the Lübeckers classification	Telephone interview seven days after the procedure performance date
Days of sickness leave	Days sick leave related to procedure performance	Telephone interview seven days after the procedure performance date

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: TrygFonden, Denmark
• Investigators: Principal Investigator: Mikael J Henriksen, MD, CAMES - Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: StressLBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No