Digital consent pathway within the electronic health record

My Topol fellowship problem / project:

Patients undergo several thousand procedures and operations every day in the NHS. Every procedure requires an important shared-decision-making (SDM) process and consent which is a conversation about the treatment options, benefits, risks and alternatives. For far too long, there has been a widespread obsession with a wet-ink signature on a piece of paper, often provided to patients just before they undergo a procedure. Many colleagues are still under the false pretence that this represents fully informed consent. It doesn’t.

The recent GMC 2020 SDM booklet highlights important steps clinicians should take to ensure patients have a comprehensive understanding of their forthcoming procedure. There is also good evidence that handwritten consent forms are often associated with errors of omission, have a lack of standardisation and are often illegible. Additionally, several recent legal cases (Montgomery 2015 and Thefaut vs Johnston 2017) have highlighted the importance of identifying both the material risk which may differ between patients and ensuring there is enough time for patients to consider such risks. There is now a shift away from using the Bolam test (what a fellow clinician of similar standing would regard as appropriate information dissemination) towards what information the patient specifically would want explained to them. This patient-centric sea change in attitude has resulted in an exponential rise in litigious claims over the past five years (£226 million, NHS Resolution), mostly surrounding a failure to warn patients appropriately.

The current consent process for many standardised procedures within the NHS is not concordant with the new GMC 2020 recommendations.

Many patients undergoing procedures within (but not limited to) cardiology for example, are often not fully pre- assessed and consequently, a sizeable minority may have their procedure postponed as they are not fully ready on the day. Additionally, the Long Term Plan has documented the desire for secondary care providers to transition to digital records by 2023. The COVID19 pandemic has created additional difficulty by reducing the ability of health care providers to deliver face to face consultations in the same fashion as previously.

With ongoing uncertainty surrounding COVID19 and lengthening waiting lists, the NHS is in desperate need for pragmatic, simplistic and patient centred solutions to improve our current clinical pathways. This is particularly important for groups of standardised and high volume procedures such as those within my speciality but equally applicable to many other specialties as well.

A recent investment to introduce a single integrated electronic health record system (EPIC) our newly formed Trust (incorporating Guy’s and St Thomas’ Hospital and the Royal Brompton and Harefield Hospitals) and Kings Health Partners, presents an enormous challenge in streamlining and integrating clinical care pathways within a digital platform.

This project will aim to develop and embed a digital consent pathway for cardiology within the new EPIC electronic health record system using our previous pilot template.

I am a Consultant Cardiologist & Electrophysiologist practising at Guy’s  and St Thomas’  NHS Foundation Trust and Honorary/Adjunct Senior Clinical Lecturer within the Department of Imaging Sciences and Biomedical Engineering at Kings College London. I am highly motivated with a passion for delivering high quality, patient centric cardiovascular care within my specialist field of heart rhythm management.

In addition to specialist clinical training, I have a PhD from Kings College London which led to the co- invention of a patented software platform collaborating with clinicians, engineers and industry partners; this was nominated for a European innovation award in 2017. Through this, I became interested in medical device innovation and digital transformation and was selected to participate in the NHS England Clinical Entrepreneur Programme, alongside full time clinical training as a heart rhythm specialist registrar at the Barts Heart Centre and a clinical lecturer in Clinical Innovation at Queen Mary University of London.

More recently as a Locum Consultant in my previous position (The Royal Brompton Hospital), I led a pilot project to digitally transform the pre assessment and consent / shared decision making process for patients undergoing cardiac procedures. This involved employing   and   configuring a variety of digital tools and working within a large multi-disciplinary team to deliver improved patient care, during the COVID19 pandemic. This work won the 2021 Royal College of Physicians Clinical Excellence Award in the Digital category and was also a finalist for the BMJ Award in the same year.