Title: Can improving the quality of surgical training enhance patient outcomes in coronary artery bypass surgery? A Cluster Randomised pilot study comparing current Endoscopic (keyhole) vein harvesting training with Structured Training- The CREST trial.
Funder: Department of Health and Social Care

Abstract: Introduction: Endoscopic vein harvesting (EVH) reduces leg wound complications and improves patient satisfaction compared with traditional open vein harvesting. Current training for EVH involves practicing on an inanimate (gel) leg model followed by one week of training on patients in the operating theatre delivered by a commercial company trainer. To improve EVH surgical techniques, I have developed the Manchester Endoscopic Learning Tool (MELT), which consists of four stages: introducing the trainees to the theory, surgical video, gradual introduction to clinical practice and vein harvesting. The first two stages are e-learning with competency based assessment and trainees are required to achieve a minimum pass mark of 80% to progress between stages. The pilot studies are also carried out to determine whether the intervention appears to have any effect and to provide some estimate of the approximate effect and the associated variability. The primary aim of this study is to assess the quality of vein graft between current EVH training and the structured MELT. Design: The study will have two stages:Stage one: Designed to optimise the MELT structured training programme, through stakeholder consultation. Feedback on training quality, practicality, limitations, teaching styles and training components will be collated through one-to-one interviews (n=24) and an expert panel (n=05) health professionals. Stakeholder feedback will be used to modify the structured training programme prior to stage two. Stage two: A multicentre cluster randomised controlled pilot trial, comparing structured training (MELT) with current training for keyhole vein harvesting. The study will recruit 08 trainees from 04 hospitals and 22 patients (11 patients during training and 11 patients after training) per trainee, with a total of 176 patients. If two trainees cannot be recruited from the same hospital, I will recruit trainees from other hospitals. This is considered feasible based on previous experience of recruiting to similar trials. I will provide structured training in keyhole vein harvesting (MELT) to the commercial trainer and at least 2 site visits to each centre at different time points to assure training consistency. Trainees' learning will be assessed using a group of validated questionnaires and two independent assessors will score harvesting techniques, using a structured protocol, by randomly selecting 1-2 video recorded cases per trainee. Expected study outcomes: The primary outcome is quality of the harvested veins as assessed by histologically confirmed damage caused by trainees. Secondary outcomes will include: trainees' anxiety levels, wound complications, patient satisfaction and clinical outcomes up to 12 months follow-up, cost effectiveness of the training programme and patient health-related quality of life using the cardiac specific SF-36 and EQ-5D-5L. The clinical outcomes end point will be measured using the validated Major Adverse Cardiac Events (MACE - repeat angina, re-intervention, myocardial ischemia, myocardial infarction, stroke and death) scoring system. Benefits: The benefits of this study include optimisation of patient outcomes, improved cost effectiveness and reduction of variation in global training practices. This will ensure that practitioners are delivering good surgical techniques under minimally stressful conditions so that patients directly benefit from a structured training programme.

Lay abstract: Main problems: Coronary artery bypass graft surgery (CABG) is a commonly performed surgical procedure for coronary artery disease. Currently, 20,000 bypass surgeries are carried out each year in the UK involving 290 surgical nurse practitioners and many more surgical trainee doctors who perform vein harvesting. A blood vessel (vein) from the leg is removed and used to bypass the blocked coronary arteries. The new vein takes over the job of supplying blood to the heart muscles and patients need to live with their vein graft for many years (typically 10-15 years). If the vein is mishandled or damaged during removal, it can become blocked. This can affect the patient's quality of life and cause repeated chest pain. Harvesting veins using keyhole surgery, has been shown to reduce wound complications and improve patient satisfaction compared to traditional open vein harvesting. Current training for keyhole vein removal in cardiac surgery typically involves a limited number of practice sessions on a leg model and one week's training in the operating room, provided by a commercial trainer. However, a structured training programme is required for this procedure, to make sure vein quality is better and to minimise problems for patients. Currently, during training, patients are used as 'Guinea pigs' by trainees. A recent survey of 151 health care professionals in 15 European countries found that 99% of specialists would like to have a structured keyhole training programme. Aim: The primary aim of this study is to assess the quality of the vein removed by trainees. The secondary aim will be to assess trainees' anxiety levels during and post training, patient satisfaction, post-surgical patient clinical outcomes and costs of care between the groups. Design: The study will have two stages: I previously developed the Manchester Endoscopic Learning Tool (MELT), a structured training programme that consists of four sections (introducing the trainees to the theory, surgical video, gradual introduction to clinical practice and vein harvesting), with a minimum pass mark of 80% for each section. The first two phases of the MELT are skill based e-learning and the second two phases are learning in clinical settings with patients. I propose a cluster randomised controlled clinical pilot trial comparing structured MELT training with current standard training. Stage one: Designed to optimise the MELT structured training programme, through stakeholder consultation. Feedback on training quality, practicality, limitations, teaching styles and training components will be collated through one-to-one interviews (n=24) and an expert panel (n=05) health professionals. Stakeholder feedback will be used to improve the structured training programme prior to stage two.Stage two: A multi-centre cluster randomised controlled pilot trial, comparing structured training (MELT) with current training for keyhole vein harvesting. The study will recruit 08 trainees from 04 hospitals and 22 patients (11 patients during training and 11 patients after training) per trainee, with a total of 176 patients. If two trainees cannot be recruited from the same hospital, I will recruit trainees from other hospitals. This is considered feasible based on previous experience of recruiting to similar trials. I will provide structured training in keyhole vein harvesting (MELT) to the commercial trainer and at least 2 site visits to each centre at different time points to assure training consistency. Trainees' learning will be assessed using a group of standard questionnaires and two independent assessors will score harvesting techniques, using a structured protocol, by randomly selecting 1-2 video recorded cases per trainee. Expected outcomes: This novel study will provide robust evidence of the clinical and economic benefits of a structured training programme for keyhole vein harvesting, with the potential to influence national and international training standards.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CARDIOVASCULAR