Development and Validation of Performance Metrics for Cardiac Device Implant Procedures
Development and Validation of Performance Metrics for Cardiac Device
Cardiac Device implantation includes implantation of pacemakers, implantable defibrillators and Cardiac resynchronisation Therapy (CRT) devices. These are well-established treatments for selected with heart rhythm abnormalities and heart failure.
In the past, trainee doctors had the opportunity to perform many procedures and learn on the patient. This is no longer the case due to a change in training schedules and working times as well as patient safety mandates. Progression based training with the use of simulators has been proven to be effective in training and in order to use this methodology, the procedure needs to be well defined.
Despite its worldwide adoption, a standardized procedure has never been defined in detail and agreed upon and the cardiac device implant technique varies with the operator.
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the research is to establish the metrics (operational definitions) necessary to characterize a reference Cardiac Device implant procedure, to seek consensus from experienced device implanters on the appropriateness of the steps as well as errors identified, and to determine if such validated performance metrics are a valid assessment tool with the ability to discriminate between the performances of experienced and novice implanters.
These validated metrics will potentially serve as an educational and training tool to improve and quality assure Cardiac device implant training.
The steps involved in characterising a reference procedure are as follows:
- Define the implant procedure in quantifiable steps (already performed)
- Seek consensus and agreement by an independent panel on the steps (already done).
- Video record routinely performed device implants by experienced and novice physicians.
- Reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance.
Undersøgelsestype
Tilmelding (Forventet)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
This is an observational and educational study only. Cardiac device implants routinely performed in clinical practice will be video-recorded.
The procedures will be scheduled as per normal and the clinical pathway and management of the patient and the operator will remain unchanged.
Beskrivelse
Inclusion Criteria:
Patients eligible for a cardiac device implant as per current European Society of Cardiology guidelines.
Exclusion Criteria:
Patient< 18 y of age. Patients unable to provide informed written consent for the study.
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Novices
Novices: Trainee cardiologists implanting cardiac devices as per guidelines under supervision
|
Observation of performance to validate matrix
|
|
Experts
Experts: Device implanting cardiologists implanting cardiac devices as per guidelines
|
Observation of performance to validate matrix
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The primary outcome measure is the comparison of the intra-operative performance of novices versus experts
Tidsramme: 6 months
|
The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8 The primary analysis will compare the intra-operative performance of novices versus experts. The three experienced cardiac device implanters will test the consented metrics by reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance. IRR will be considered to be acceptable if it is ≥ 0.8 |
6 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1189
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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