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

NCT02185079 | Completed

• 1 other identifier: ECM4(i)06/05/2014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

labor; epidural

Outcome Measures

Primary Outcomes (1)

• Epidural failure rate

  Failure rate of epidural will be assessed based on the occurrence of one or more of the following events, 1. Inadequate analgesia at 45 minutes from start of epidural needle placement. 2. Resiting epidural or abandoning the procedure. 3. Accidental Dural puncture. 4. Supervisor take over.

  within 48 hours after completion of epidural

Secondary Outcomes (2)

• assessment of clinical performance using metrics based assessment

  within 36 months after aquiring the video of epidrual catheter insertion procedure

• patient satisfaction with epidural analgesia

  within 48 hours of completion of insertion of labor epidural catheter

Study Arms (2)

Group C

ACTIVE COMPARATOR

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.

Behavioral: Conventional training

Group M

EXPERIMENTAL

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.

Behavioral: Training to proficiency

Interventions

Training to proficiency BEHAVIORAL

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.

Group M

Conventional training BEHAVIORAL

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.

Group C

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not consenting for study

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork,Ireland, Cork, Ireland

Location

Related Publications (1)

• 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.

  PMID: 30327396 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar,Anaesthetics,Cork University Hospital

Study Record Dates

• First Submitted: July 5, 2014
• First Posted: July 9, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

IE (1)