Introducing change to clinical practice to address areas of unmet need is complex, both within the NHS and for private healthcare providers; from ensuring patient safety to developing a thorough case for investing in new methods or equipment, a number of considerations must be taken into account.
This was the challenge faced by Dr. Indira Natarajan, Consultant Stroke Physician for the Royal Stoke University Hospital’s acute stroke team, part of the University Hospitals of North Midlands NHS Trust. Recognising that a number of immobile patients, who had suffered ischemic or haemorrhagic strokes are unable to tolerate intermittent pneumatic compression (IPC) to prevent venous thromboembolism (VTE), Dr. Natarajan led an observational pilot study to assess a new neuromuscular electrostimulation technology (the gekoTM device) to address this significant unmet need.
Through close collaboration with the developer of the device, Sky Medical Technology, Dr Natarajan has been able to pioneer a change to clinical practice in his unit to the great benefit of his patients and team. His work is driving adoption of the device and change to clinical practice in additional stroke centres in the UK and abroad. In this article, Dr Natarajan talks through the burden VTE presents for stroke aftercare, and his experience of taking forward change to clinical practice.
Venous thromboembolism (VTE) is a common complication for hospitalised patients, often as a result of restricted mobility. It puts patients at risk of potentially fatal blood clots, and some estimations suggest there are nearly 40,000 deaths in England per year as a result of VTE – over 62% of which could be prevented through proper management and care*.
In particular, acute stroke patients are a highly at-risk population due to reduced mobility, with many patients left bedbound when recovering from the debilitating illness.
NICE guidance (NG89) recommends Intermittent pneumatic compression (IPC) as the primary early intervention method to prevent venous stasis in immobile Stroke patients. However, observations from staff at the Royal Stoke University Hospital’s Stroke unit, for which I am a Consultant Stroke Physician and clinical director for neurosciences, suggested that roughly 30% of our patients were unable to tolerate or were contraindicated for IPC. An alternative anti-stasis intervention was evidently needed to ensure the betterment of treatment for our patients, and to ensure all patients would have access to a preventative measure.
The Royal Stoke’s Stroke unit keeps the betterment of patients at the heart of everything it does. As a team, we value remaining at the forefront of innovative treatment and care, and the importance of investing time, effort and determination into improving patient outcomes. This was the driving force behind our decision to embark upon an observational pilot study to assess a new VTE preventative method, which could prove a lifeline for at-risk immobile acute stroke patients.
Current standards of care
One of the challenges facing stroke clinicians is the currently limited standard of care for post-stroke VTE management, which in the first instance recommends the use of Intermittent Pneumatic Compression (IPC) sleeves. Not only can these prove uncomfortable for patients, there are a number of contraindications for IPC treatment; some patients present with ulcers or poor blood circulation, making IPC treatment impossible. A stroke can also impair cognitive function in patients, who may then remove the sleeves due to discomfort – making it more difficult to monitor patients to ensure they are consistently and correctly wearing the sleeves at any one time.
Additionally, whilst anti-coagulants could be used on a small subset of patients who are contraindicated for IPC, drugs are not recommended by NICE in the first instance due to the possibility of haemorrhagic transformation. Furthermore, hyperacute stroke patients are unable to receive drugs at all, so if they also cannot tolerate IPC, a gap in care begins to emerge.
This gap represented an urgent area of unmet clinical need, brought about by the restrictions of only having one non-pharmacological intervention – which limited us to prevent VTE in every at-risk patient.
The baseline VTE incidence risk of this unmet need in acute stroke patients, reported in the CLOTS3** study, is 8.7% (no IPC, plus standard measures). The CLOTS3 study also reports that >30% of acute stroke patients can be contraindicated or not tolerate IPC.
Addressing the need
As a unit, we firmly believe that we must make every effort to provide a standard of care that encompasses the entire patient population. This significant unmet need gave us the opportunity to think outside of the box, and explore new ways to address VTE prevention.
We were fortunate to meet with the company Sky Medical Technology Ltd (Sky), a developer of a neuromuscular electrostimulation (NMES) technology. They were particularly interested in exploring its effectiveness in VTE prevention, and reached out to our unit to discuss collaborative research. The technology, embedded in a small, wristwatch-style device called the gekoTM, sends painless, regular electrical pulses down a patient’s lower limb, stimulating the common peroneal nerve in the lower leg and activating calf and muscle pumps. The mechanism of action increases blood flow in the deep veins of the calf – equal to 60% of the blood flow rate of walking, without the patient moving – thereby preventing vascular complications associated with restricted mobility, a common risk for bed-bound stroke patients. It had clear potential as a non-invasive, non-pharmacological intervention to prevent VTE in a patient group contraindicated or unable to tolerate IPC.
Of course, all treatment must be evidence based. As a unit, we recognised the need to generate data to determine geko™ device efficacy and to remain aligned to our priority of patient safety. We agreed to qualify, through an observational pilot study, patient contraindication and intolerance to IPC, to measure geko™ compliance compared to IPC, and to measure VTE events at 90 days post-stroke.
Changing clinical practice
From my experience of exploring clinical practice change, there can be times of failure. There have been times when the team thought we were at the forefront of innovation and it just didn’t work. However, times of failure are times of learning – and it’s better to say you tried and it didn’t work, as you’ve been given the opportunity to think outside of the box. This fearless approach was vital when commencing the pilot.
Any pilot study involving patients involves a huge amount of staff effort, time and investment, not least of all for the initial stages of securing buy-in from the Trust. Rigorous processes of governance are required pre-study, and we first contacted the Directorate Governance for neurosciences to inform them of our wish to commence a pilot observational study and make a solid case for pursuing it. The study also sought permission from Divisional Governance and Trust Governance; these groups were on hand to approve each stage of the study, including the proposed inclusion / exclusion criteria and the process of patient recruitment, monitoring and follow up. It was thanks to the collective effort of the stroke unit team, who ensured the study proposal was properly devised, that Governance agreed permission and support for the pilot.
Given that we were exploring the use of the gekoTM as a prescribed device, we also informed the Royal Stoke University Hospital pharmacy in order to add the gekoTM to a drug chart alongside other standards of care for VTE; this was an important step, which allowed us to implement use of the device in the study. It was also vital to have a database in place to enable the team to track and carefully monitor patients selected to participate.
With an initial patient goal of 1,000, it took roughly around one year to collect data from each patient. A study of this scale meant our unit needed additional staffing support and training, and the commitment and buy-in of the entire team to offer their time to making the pilot a success. Working with Sky, a training programme was put in place to get staff familiar with the device. Additional staff were also enlisted to ensure regular daily checks were carried out with each patient, and participants received regular follow-ups once they had left the unit.
A study of this scale represented a monumental level of commitment and effort from the team, but our priority has always been to provide the best outcomes for patients. Having identified a gap in care and the need for change, and having overcome initial apprehensions regarding a potential modification to practice, there was a collective drive to embrace a new, innovative method to ultimately offer improved treatment for all patients – particularly the at-risk cohort.
Introducing change requires leadership, energy and collaboration. In our case, the close collaboration and support of key stakeholders, including Governance, staff, and most importantly, patients, enabled us to evaluate this new way of preventing VTE.
Pilot results & patient benefit
Diligent analysis of the initial 1,000 patient data-set took just under one year – and the incredible effort of the team soon became worthwhile. Of this 1,000 patients, 29.5% were contraindicated or unable to tolerate IPC (this figure is in line with the CLOT3 findings), making them eligible for an alternative anti-stasis intervention – the gekoTM device. Our data showed that of 463 patients prescribed IPC, 11 patients (2.4%) suffered a VTE event. Of the 203 patients prescribed the geko™ device, no incidence of VTE was reported 90 days post-discharge.
NICE guidance MTG19 supports use of the geko™ device for people who have a high risk of VTE and for whom pharmacological or other mechanical methods of VTE prevention are impractical or contraindicated. The Royal Stoke team has since implemented NICE guidance when IPC cannot be prescribed.
Over 90% of patients tolerated the geko™ device, which was favourable when compared to patients prescribed IPC. Compliance feedback was overall very positive, giving reassurance to the unit that this study had been correct and right to pursue.
Since sharing these results, our unit has continued with an expansion of the data. There are other stroke units across the country also exploring use of the device to prevent venous stasis, and it’s been gratifying to hear from peers in stroke care who recognise the potential for this study and its benefits to patient recovery and outcomes.
Embracing change and innovation
Introducing change to clinical practice to address areas of unmet need is complex, especially within the NHS; from ensuring patient safety to developing a thorough case for investing in new methods or equipment, a number of considerations must be taken into account. It is by no means an easy undertaking, and it takes considerable investment of staff time, effort and dedication. However, remaining at the forefront of innovation, carefully gathering evidence and exploring new alternatives, will benefit our patients and improve treatment in the long term.
To fellow clinicians considering implementing change in their wards and units, I always recommend careful deliberation and consideration of how pressing the issues facing your patients and team are. If there is major need and, most importantly, if patient benefit is going to be a tangible outcome as a result of change, explore the alternatives to the existing standards of care and embrace innovation. Every clinician keeps patients at the centre of good practice, and ultimately, anything that is good for the patient, their experience, outcomes and benefits, gives a solid platform to move forward with change.
* Reducing deaths from blood clots in hospitals – the role of NHS boards; The NHS Confederation
** The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness; Dennis et al, (2015)
About University Hospitals of North Midlands NHS Trust
Serving around three million people across Staffordshire and North Wales, UHNM is one of the largest hospital trusts in the country. Its 10,000 strong workforce provides the full range of emergency treatment, planned operations and medical care from its two sites at County Hospital, Stafford and Royal Stoke University Hospital, Stoke-on-Trent.
The Trust also provides specialised services for three million people in a wider area, including neighbouring counties and North Wales. Its specialised services include cancer diagnosis and treatment, cardiothoracic surgery, neurosurgery, renal and dialysis services, neonatal intensive care, paediatric intensive care, trauma, respiratory conditions, spinal surgery, upper gastro-intestinal surgery, complex orthopaedic surgery, laparoscopic surgery and the management of liver conditions.
Royal Stoke University Hospital, one of our two sites, is a large acute teaching hospital on the border of Stoke-on-Trent and Newcastle-under-Lyme in Staffordshire. The other site is County Hospital in Stafford. They are one of the largest Trusts and have one of the busiest emergency departments in the country.