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Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement

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ClinicalTrials.gov Identifier: NCT02179879
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital

Tracking Information
First Submitted Date June 30, 2014
First Posted Date July 2, 2014
Last Update Posted Date August 28, 2015
Study Start Date November 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2014)
Construct validitiy [ Time Frame: WIthin 12 months post recording epidural procedure video ]
a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure.In our study we aim to see if the metrics developed will be able to differentiate between experts and novices in performing the porcedure
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 30, 2014)
  • Concurrrent validity [ Time Frame: within 12 months following completion of epidural video recording ]
    Concurrent validity is defined as a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure.We aim to compare the interrater reliability of the metrics with compare with likert-scale checklists/global rating scale system developed already for the procedure.
  • Interrater reliability [ Time Frame: 12 months from time of aquiring the epidural video ]
    We will evaluate the inter-rater reliability of the metrics using i) proportion of agreement between raters, ii) correlation strength (using Pearson's Correlation Coefficient) and iii) Coefficient Alpha
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement
Official Title Protocol for Development and Validation of Metrics for Conventional Lumbar Epidural Catheter Placement for Labor Analgesia in Obstetric Patients
Brief Summary

Procedural skills play an important role in anaesthetic expertise. More focused training and assessment of procedural skills will be needed in the future as training moves from an apprenticeship based training system to competency based assessment.

Currently various techniques exists to assess procedural skills of anaesthetist. For epidural catheter placement, task specific check list, global rating scales and cumulative sum techniques have been developed and validated. These techniques aim either for better qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in objectivity in turn hampers inter-rater reliability which is an essential component of a valid assessment model. Checklists type assessments force the developer to comprehensively characterize the procedure of interest and then validate the completed procedure characterization. This approach has been quantitatively shown to have higher assessment reliability levels compared to Likert-scale assessment.

The objective of the project is to develop and validate a comprehensive procedure characterization for labor epidural catheter placement. Another objective is to compare this new assessment tool with existing checklist and global rating scale for labor epidural to establish concurrent validity.5 A well-developed objective, validated procedure characterization serves as a master tool which has multiple applications. It helps to build a training programme for the procedure, allows providing metrics based feedback to trainees using simulator, helps to assess the performance of trainees and in future might be used as benchmark to allow competency based progression in the training.

Detailed Description

Study part 1 After ethics committee approval a group of experts (n = 3 ) in conventional lumbar epidural catheter placement will be selected (an expert is defined as one who has performed more than 500 labor epidurals in preceding 5 year period). During a number of face-to-face meetings experts will identify, characterize and define the procedure. They will analyze task and identify units of behavior to be measured which constitute in a step-wise fashion how the procedure is optimally performed and deviations from optimal procedure performance as described previously. After informed consent from the patient and the anaesthetist performing the procedure, 2 video recordings of experts performing epidural and 2 video recordings of novices (defined as one who has done less than 50 epidurals) performing epidural will be recorded for detailed review during metric development meetings.

Study part 2 The developed metrics will be subjected to assessments of construct validity (a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure) and concurrent validity (the evaluation in which the relationship between the test scores and the scores on the another instrument purporting to measure the same construct are related). We will also evaluated the inter-rater reliability of the metrics using i) proportion of agreement between raters, ii) correlation strength (using Pearson's Correlation Coefficient) and iii) Coefficient Alpha. After informed consent,10 experts (who are not a part of committee developing the metrics) each performing one or more lumbar epidural catheter placements for labor and 10 novices each performing one or more lumbar epidural catheter placements for labor will be video recorded. Two experts will review the video recording and score the performance based on checklist based system developed and compare with likert-scale checklists/global rating scale system.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Expertes and novice anaesthetist perfoming labor epidural analgesia
Condition Labor Pain
Intervention Other: Video validation
Video taping of anaesthetist (experts and novices) perfoming labor epidural.
Study Groups/Cohorts Video validation group
This will include video taping of experts (defined as one who has performed more than 500 labor epidurals in preceding 5 year period) and novices (defined as one who has done less than 50 epidurals in preceeding 2 years) perfoming labor epidural
Intervention: Other: Video validation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 30, 2014)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • an expert is defined as one who has performed more than 500 labor epidurals in preceding 5 year period
  • novice (defined as one who has done less than 50 epidurals in previous 2 years)

Exclusion Criteria:

  • Non consenting anaesthetist
  • Patients not consenting for video recording
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02179879
Other Study ID Numbers ECM4(U)01/10/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital
Study Sponsor Cork University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD Cork University Hospital
PRS Account Cork University Hospital
Verification Date August 2015