Dr. Indira Natarajan, consultant stroke physician for the Royal Stoke University Hospital’s acute stroke team writes about a change to clinical practice. He talks through the burden venous thromboembolism (VTE) presents for stroke aftercare, and adopting the geko device, developed by Sky Medical, to treat patients.
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 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 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 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.
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 emerging unmet need gave us the opportunity to think outside of the box, and explore new ways to address VTE prevention.
Eventually we came across a company, Sky Medical Technology (Sky), a developer of a neuromuscular electrostimulation (NMES) technology. It was 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 geko, 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. This is intended to increase 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 for IPC.
Of course, all treatment must be evidence based. As a unit, we had to provide data to support the efficacy of the device and our priority at this stage was to ensure patient safety. We agreed as a team to explore an observational pilot study to assess safety, evaluate the difference the geko could make to patients, monitor if patients could tolerate it well (compared to IPC sleeves) and scope out any issues.
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 and 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 geko as a prescribed device, we also informed the Royal Stoke University Hospital pharmacy in order to add the geko 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 30%.
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 set took just under one year – and the incredible effort of the team soon became worthwhile. Of this 1,000, 29.5% were contraindicated or unable to tolerate IPC (in line with our prior observations), making them eligible for an alternative anti-stasis intervention – the geko device. Our data showed that of 463 patients treated with IPC, 11 patients (2.4%) suffered from VTE. Of the 203 patients prescribed the alternative VTE prevention method – the geko – no incidence of VTE was reported 90 days post-discharge.
NICE has since recognised this data, with NICE guidance MTG19 now recommending the use of the geko device for hyper-acute stroke patients contraindicated for IPC treatment and who, as mentioned earlier, are unable to receive anticoagulants. This is testament to the quality of the data, and the dedication and effort of the entire Royal Stoke University Hospital stroke unit.
The majority of patients tolerated the device well, finding it more comfortable and allowing them to be more mobile, as compared to patients undergoing IPC treatment. 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.