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

16 juillet 2018 mis à jour par: Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital

The Effect of Metrics Based Performance Based Progression in Provision of Labor Epidural Analgesia on Clinical Performance and Clinical Outcome

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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,

  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. 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.

Type d'étude

Interventionnel

Inscription (Réel)

16

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Irlande
    • Cork
      • Cork,Ireland, Cork, Irlande
        • Cork University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

23 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group C
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.
Comportemental: Conventional training
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.
Expérimental: Group M
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.
Comportemental: Training to proficiency
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Epidural failure rate
Délai: within 48 hours after completion of epidural

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
assessment of clinical performance using metrics based assessment
Délai: within 36 months after aquiring the video of epidrual catheter insertion procedure
assessment of clinical performance using metrics based assessment will be done by two blinded reviewers based on video recordings
within 36 months after aquiring the video of epidrual catheter insertion procedure
patient satisfaction with epidural analgesia
Délai: within 48 hours of completion of insertion of labor epidural catheter
Patient will be asked to rate eidural as (a) satisfied, will want it again (b) Not satisfied - give reason in free text
within 48 hours of completion of insertion of labor epidural catheter

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cork University Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2014

Achèvement primaire (Réel)

1 décembre 2017

Achèvement de l'étude (Réel)

1 décembre 2017

Dates d'inscription aux études

Première soumission

5 juillet 2014

Première soumission répondant aux critères de contrôle qualité

8 juillet 2014

Première publication (Estimation)

9 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2018

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ECM4(i)06/05/2014

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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