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.

Study Overview

• Status: Unknown
• Conditions: Educational Problems
• Intervention / Treatment: Other: implant of cardiac device as per guidelines

Detailed Description

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:

1. Define the implant procedure in quantifiable steps (already performed)
2. Seek consensus and agreement by an independent panel on the steps (already done).
3. Video record routinely performed device implants by experienced and novice physicians.
4. Reviewing and scoring the video recorded procedures to verify that the metrics distinguish between a novice and an expert cardiac device performance.

• Study Type: Observational
• Enrollment (Anticipated): 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Novices; Novices: Trainee cardiologists implanting cardiac devices as per guidelines under supervision	Other: implant of cardiac device as per guidelines; Observation of performance to validate matrix
Experts; Experts: Device implanting cardiologists implanting cardiac devices as per guidelines	Other: implant of cardiac device as per guidelines; Observation of performance to validate matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure is the comparison of the intra-operative performance of novices versus experts	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

Collaborators and Investigators

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): May 30, 2019

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Presentation at national and international meetings
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: as above
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No