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The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Training to proficiency
Conventional training
Sponsored by
Cork University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain focused on measuring labor, epidural

Eligibility Criteria

23 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study.

Exclusion Criteria:

  • No tmeeting inclusion criteria
  • Not consenting for study

Sites / Locations

  • Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group C

Group M

Arm Description

Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.

Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator.

Outcomes

Primary Outcome Measures

Epidural failure rate
Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, Inadequate analgesia at 45 minutes from start of epidural needle placement. Resiting epidural or abandoning the procedure. Accidental Dural puncture. Supervisor take over.

Secondary Outcome Measures

assessment of clinical performance using metrics based assessment
assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings
patient satisfaction with epidural analgesia
Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text

Full Information

First Posted
July 5, 2014
Last Updated
July 16, 2018
Sponsor
Cork University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02185079
Brief Title
The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia
Official Title
The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia on Clinical Performance and Clinical Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Procedural skills are an important determinant of clinical outcomes for certain patient groups. Training for procedural skills in the medical profession is still largely based on an apprenticeship model. For example, trainees learning to perform epidural anaesthesia do so by "practicing" on patients under direct supervision by seniors (consultants or senior registrars/residents). Learning a complex and high risk procedural skill on patients is not ideal. As medical training moves from apprentice based to competency based training along and as for the number of clinical learning opportunities for trainees is less, it is necessary to develop a comprehensive training programme which enables effective and efficient learning without compromising on patient safety. Metrics-based performance based progression has shown to improve clinical performance not only in novices but also in experts. We envisage a standard methodology which could address the deficiencies in procedural training currently. This would entail development and validation of a set of metrics for a particular procedure, evaluation of a proficiency based progression training programme based on those metrics to and demonstration of improved clinical performance and clinical outcome associated with that programme. Although elements of this "end -end" approach have been demonstrated previously for various procedures, we propose to apply this methodology in its entirety to placement of a lumbar epidural catheter for analgesia for patients in labor. To date we have developed and are validating a set of metrics for this procedure. Proficiency based training leading to better procedural skills leading to better patient outcomes has not been studied so far. Epidural analgesia during labor lends itself as an excellent model for evaluating the whole process. It has a specific procedural skill which is closely linked to patient outcome which is measurable and occurs in finite time interval. The hypothesis of the study is that in novice anaesthetic trainees, training with metrics based performance based progression in addition to improving the clinical performance will also reduce the failure rates of labor epidural analgesia to 5% when compared to 25% achieved by conventional training.
Detailed Description
This will be a prospective, randomized, double blind control study. Ethical committee approval and consent from both participating anaesthetist and patients will be obtained. Trainees will be recruited from Cork University Hospital. Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study. The trainees will be randomized in to group 1 and group 2. In group 1, standardized conventional teaching and training for labor epidural analgesia will be used. In group 2, they will be trained by metrics based simulation to predetermined level of proficiency. Each trainee will then perform 10 labor epidural catheter insertions and the procedures will be video recorded with patients consent. Observers blinded to the groups will be used for the data collection, outcome assessment and analysis. Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, Inadequate analgesia at 45 minutes from start of epidural needle placement. Resiting epidural or abandoning the procedure. Accidental Dural puncture. Supervisor take over. The primary end point of the study is to compare difference in epidural failure rates between the two groups. Secondary end point will include assessment of clinical performance using metrics based assessment by two blinded reviewers based on video recordings and patient satisfaction with epidural analgesia. In addition to demographic data of the patients, duration of labor, cervical dilation at the time of insertion of the catheter, length of catheter inserted, time of insertion of catheter, experience of the operator and position of the patient during epidural placement will be noted. Age, sex and anaesthesia experience of the trainees will also be collected. The estimated labor epidural failure rates for year 1 trainees is 25%.6 We hope to reduce the failure rate in interventional group to 5%. 48 procedures per group will be sufficient to show a statistically significant difference between the groups with p value of 0.05% and power of 80%. To allow for dropouts, 8 trainees per group will be recruited and each will perform 10 procedures making it a total of 80 procedures per group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor, epidural

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
Arm Title
Group M
Arm Type
Experimental
Arm Description
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be subjected to training to proficiency based on the metrics developed for labor epidural catheter placement in a epidural simulator.
Intervention Type
Behavioral
Intervention Name(s)
Training to proficiency
Intervention Description
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator.
Intervention Type
Behavioral
Intervention Name(s)
Conventional training
Intervention Description
Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
Primary Outcome Measure Information:
Title
Epidural failure rate
Description
Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, Inadequate analgesia at 45 minutes from start of epidural needle placement. Resiting epidural or abandoning the procedure. Accidental Dural puncture. Supervisor take over.
Time Frame
within 48 hours after completion of epidural
Secondary Outcome Measure Information:
Title
assessment of clinical performance using metrics based assessment
Description
assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings
Time Frame
within 36 months after aquiring the video of epidrual catheter insertion procedure
Title
patient satisfaction with epidural analgesia
Description
Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text
Time Frame
within 48 hours of completion of insertion of labor epidural catheter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anaesthetic trainees with less than 2 years of experience in anaesthesia and who has performed less than 50 epidurals in the preceding 2 years (not limited to labor epidurals) will be requested to participate in the study. Exclusion Criteria: No tmeeting inclusion criteria Not consenting for study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD
Organizational Affiliation
Cork University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork,Ireland
State/Province
Cork
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30327396
Citation
Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.
Results Reference
derived

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The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia

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