Leg ulceration is a common cause of suffering for patients. Its treatment places a significant burden on the NHS, especially within community nursing services (Atkin and Critchley, 2017). Despite the abundance of literature and evidence available, there are significant variations in leg ulcer management in clinical practice. Such variations have been highlighted by NHS England's ‘Betty's Story’ under the ‘Leading Change, Adding Value’ framework, which provided detailed evidence on unnecessary spend, multiple visits to healthcare providers, elongated healing times, and impact on patients' quality of life. National initiatives, such as the Legs Matter campaign (Legs Matter, 2018) and National Wound Care Strategy Programme (The AHSN Network, 2018), set aims to increase overall awareness and improve patient care. It is vital that health services move towards the elimination of unwanted variations on leg ulcer management, ensuring that all patients are appropriately and timely assessed, that diagnosis of underlying pathophysiology is clear, and that evidence-based interventions form the heart of treatment plans.
Prevalence, management and cost
Prevalence of lower limb ulceration is reported at 1.5% of the UK's adult population (Guest et al, 2015), increasing to 3% for those over 80 years old (Gohel and Poskitt, 2010). It is estimated that 730 000 patients have an active leg ulcer every year (Guest et al, 2015) and, with prevalence of lower leg ulceration increasing due to an ageing population, it is likely that this figure will rise and lead to an even greater burden on NHS services (Atkin and Tickle, 2016).
The majority of patients with lower limb ulceration are managed by community nursing services, but this often goes hand-in-hand with referral to specialist services, such as tissue viability, plastic surgeons, dermatologists or vascular specialists (Cullum et al, 2016). The cost of managing patients with lower limb ulceration is substantial (Guest et al, 2015), and the expenditure from wound-dressing prescribing alone has increased by 21% between 2004 and 2012, with over 9 million wound dressing items being prescribed in the community at a cost of £184 million in 2012 (Cullum et al, 2016). Dressing costs only account for 15% of the overall costs of managing patients with chronic wounds—the main cost drivers being health professional visits and hospital admissions (Guest et al, 2017).
There are also costs to the patient, which can be financial (eg prescriptions and inability to work) or non-financial, such as the impact on their quality of life (Herber et al, 2007). Guest et al (2015) analysed retrospective data from a cohort of 1000 randomly selected health records contained within The Health Improvement Network (THIN) database, which holds over 11 million patient records from 562 general practices across the UK. The information gained from this analysis was used to provide estimations of the prevalence of wounds in the UK and their associated treatment costs. The results showed that, out of 730 000 patients with a leg ulcer, only 278 000 had been identified as having a venous ulcer. This equates to only 38% of patients with lower limb ulceration, which is far from the published evidence of around 70% of all ulceration being due to venous disease (Casey, 2004).
Poor healing rates and use of compression therapy
Only 16% of patients received ankle-brachial pressure index (ABPI) assessment (Guest et al, 2015). This raises the question of whether patients are being appropriately and formally diagnosed, hence the potential underestimation of overall numbers of venous ulceration reported in the study. This lack of recognition and diagnosis of venous hypertension goes against the best practice statement (BPS) for venous leg ulceration (Wounds UK, 2016) and could lead to the underuse of compression therapy, or patients not being appropriately referred for venous imaging. Furthermore, the healing rate for venous leg ulcers (VLUs) has been reported as low as 47% at 12 months (Guest et al, 2017). This is far inferior to the number reported within research evidence for compression therapy, which highlights a mean healing time of 90–99 days (O'Meara et al, 2012).
One of the main causes of poor healing rates is the under-use of compression therapy (Cullum et al, 2016). Despite the robust, high-level evidence proving its effectiveness in healing VLUs (O'Meara et al, 2012; Nelson and Adderley, 2016), a large proportion of patients are not getting compression therapy. Cullum et al (2016) undertook a multiservice, cross-sectional survey to identify the number, nature and care of complex wounds across Leeds, UK. The survey was conducted in community and primary care services, mental health services, acute services and independent care providers, such as nursing homes and hospices. The results showed that only 68% of patients with a VLU were using full compression (equivalent to the recommended 40 mmHg).
The reasons for the suboptimal use of compression are unclear, but are likely to be related to lack of staff knowledge and confidence (Adderley and Thompson, 2017). Compression hosiery kits (where the compression pressure is applied by the garment and not related to the practitioner's skill/competency) could help tackle one of the issues of confidence and skill mix, ensuring that the compression levels are never too high, which could put the patient at risk of tissue damage from over compression.
Compression hosiery kits have proven to be as effective in healing VLUs as multilayer bandaging. A large randomised control trial (RCT) (Ashby et al, 2014) funded by the National Institute for Health Research (NIHR) found no evidence of a difference in venous ulcer healing between compression hosiery kits and multilayer bandaging. It also showed that compression hosiery kits may reduce ulcer recurrence rates when compared with multilayer bandaging, and be a cost-effective treatment.
Assessment and diagnosis
Before implementing any form of compression, it is essential that a patient's peripheral arterial circulation is assessed to ensure that compression therapy is not contraindicated. Within the majority of UK policies and international best practice guidelines (Franks et al, 2016; Wounds UK, 2016), an ABPI is recommended as a means of assessing peripheral arterial disease and a patient's suitability for compression. However, there are many barriers in completing this test: availability of equipment, lack of time and competency, presence of substantial oedema, ulcer location and lack of patient's ability to lay flat or to tolerate the procedure (Atkin and Tickle, 2016; British Lymphology Society (BLS), 2018; Staines, 2018).
Without a documented ABPI, there is reluctance to apply compression therapy. Guest et al (2015) showed that only 16% of patients in their audit had a documented ABPI, meaning 84% of patients did not potentially have ‘the key to the door’ of compression therapy. Additionally, if the ABPI is elevated (above 1.3, as a result of arterial wall calcification), the compression therapy can once again be delayed or not even applied due to local guidelines, even where venous disease/oedema is the underlying physiology.
Yet performing an ABPI is not the only means to detect peripheral arterial disease. Other assessment skills, such as pulse palpation, Doppler auscultation and toe pressure, can be used. Delaying compression treatment just because ABPI cannot be documented is poor care and can result in patient harm. The BLS (2018) position statement on ABPI challenges the sole use of using ABPI in informing decision-making. Ultimately, arterial assessment only forms one part of the assessment of a patient with lower limb ulceration, and this needs to be done in combination with a clinical assessment of the patient and clinical presentation of the ulceration, gathering relevant patient information to aid diagnosis and appropriate treatment planning.
An updated pathway
The introduction of formalised, evidence-based pathways is one solution to help reduce unwanted variations in clinical practice. Such pathways can optimise the quality of treatment and improve patient satisfaction (Hensen et al, 2005; Grol and Buchan, 2006).
The leg ulcer pathway by Atkin and Tickle (2016) provides guidance to assist health professionals in the management of lower limb ulceration. It enables the user to determine the ulcer aetiology, signpost when onward referral is required and select cost-effective compression. It incorporates clinical evidence, such as the VenUS IV study (Ashby et al, 2014) and the EVRA study (Gohel et al, 2018), aiming to assist practitioners with compression selection for venous leg ulceration. Documented outcomes of using this pathway include increased healing rates, improved documentation, optimised use of compression hosiery kits and reduced number of nursing visits (Atkin and Critchley, 2017).
This pathway was updated in 2018 to ensure it remained in line with research evidence (Gohel et al, 2018). The need to assess patients for correctable venous disease is now at the heart of the pathway. Gohel et al's (2018) RCT showed significant improvement in terms of healing times (median time reduced from 82 days to 56 days, p=0.001) when patients were treated with early venous ablation. It is vital that clinical pathways take into account such evidence, so that improved healing times can be achieved in clinical practice to optimise healing rates and reduce costs, as well as patient suffering.
This article describes the implementation of the updated pathway in two geographical areas: Lincolnshire and Leicestershire.
Pathway implementation in Lincolnshire
Background
In North Lincolnshire community services, patients with leg ulcers are either seen at home or in care homes by district nurse (DN) teams, or attend local GP practices where practice nurses (PNs) are usually the first health professionals to assess and manage the wound. There is also a chronic wound clinic service, which functions in different locations across the large geographical community area and predominantly delivers leg ulcer care, with referrals from primary care for hard-to-heal wounds.
Leg ulcer training had not been provided for several years, but with the appointment of a tissue viability nurse (TVN) lead in April 2017, an audit of patients with active leg ulceration was undertaken. The aim was to identify if ABPI assessment was being done, if patients were receiving compression therapy (and which type), and what wound durations at presentation were.
Methods and results
A total of 15 patients with VLUs present for >4 weeks were recruited from DN caseloads using the patient online record system. Of those 15 patients, six had a VLU for >6 months, nine had not received a Doppler assessment and only five were using compression, which was a reduced 3-layer bandage system. It was decided to implement a leg ulcer pathway (Atkin and Tickle, 2016) in order to standardise care across the community services and introduce the right care the first time. There was also a need to raise awareness on the different types of compression bandage systems and compression hosiery kits available.
In October 2017, after implementing the leg ulcer pathway (Atkin and Tickle, 2016) and a new education programme in the community with compression hosiery kits as a first-line treatment, the community staff were invited to complete a SurveyMonkey questionnaire. A total of 26 community nurses responded, all saying they felt confident in the selection and application of compression hosiery kits. They also described being more confident when assessing leg ulcers (including Doppler assessment), and said they were motivated by seeing healing rates increase and by receiving good patient feedback.
In the chronic wound clinic setting, the introduction of the pathway and compression hosiery kits as a first-line treatment released more time for new assessment appointments, which are usually more comprehensive and take longer than standard treatment appointments. This resulted in shorter referral times—application of compression hosiery kits is less time-consuming than compression bandaging.
Another audit took place in the chronic wound clinic in October 2018. The pathway and compression hosiery kits as a first-line treatment had been in place for 12 months, therefore effectiveness was reviewed. A total of 30 patients who presented to primary care centres, GPs and/or practice nurses with a leg ulcer >4 weeks old on referral were recruited and commenced treatment following the compression pathway. The results showed:
In summary, using a patient-centred approach and introducing a leg ulcer pathway may help reduce the national leg ulcer burden.
Pathway implementation in Leicestershire
Background
Leicestershire Partnership NHS Trust's (LPT) is a joint mental health and community trust covering a population of just over 1 million people in Leicester, Leicestershire and Rutland. The launch of the BPS for venous leg ulceration (Wounds UK, 2016) and the potential to reduce caseloads and improve patients' quality of life was recognised by the LPT tissue viability service (TVS), and coincided with the development of a local lower limb management guideline and compression treatment review.
Pathways in LPT's guideline were amended to include compression hosiery kits and compression wrap systems, and the band of staff that could apply them—this meant healthcare assistants (HCAs) could apply compression hosiery kits, releasing time for registered nurses (RNs) to focus on more complex visits. Any change in compression treatment options had to be agreed with local clinical commissioning groups (CCGs), who provide funding for wound management.
L&R (L&R Medical, UK) provided support in designing a roll-out plan to implement a leg ulcer pathway (Atkin and Tickle, 2016). This was then presented to CCGs and LPT's clinical network for approval (the clinical network comprises clinicians from multiple disciplines and operates as part of the Trust's clinical governance process). In order to proceed with implementation, it was imperative to show the potential benefits of the pathway and new compression therapy options.
Community nursing within LPT consists of eight hubs with 30 teams. Leg ulcer management is provided through lower limb clinics led by those teams, or at the patient's home (if house-bound). The pathway was adapted in line with LPT products. The new product range excluded 3-layer and 4-layer compression systems, and added compression hosiery kits and a compression wrap system (ReadyWrap, L&R). This provided additional options that were user-friendly and reported to be clinically- and cost-efficient (compression wrap systems allow for adjustment as swelling reduces, as opposed to compression bandaging, where the nurse would be called out to reapply).
Methods and results
To ensure support for nursing teams, the TVS promoted a structured implementation of the pathway. Implementation meetings with the TVS clinical lead led to the development of an implementation strategy. This included pre-implementation case note review, distribution of printed resources, hub-by-hub roll out, intensive company representative support, updated lower limb training, and an audit. One of the biggest barriers was enabling the supply route, as NHS Supply Chain had delisted the majority of compression products. L&R worked with LPT procurement to address this issue through a series of meetings, identifying logistical problems, current supply methods and potential alternatives. Accounts were set up with North West Ostomy Supplies (NWOS) to allow stock to be ordered for roll-out.
LPT used Formeo as its ordering platform. To ensure hubs were not ordering items they had not been trained to use, the relevant section of Formeo only went live when roll-out was booked for that hub. Initial roll-out identified that nurses had ‘favoured’ compression bandage systems and were unfamiliar with the application of short-stretch bandages, but were keen to try the new compression hosiery kits.
At each hub roll-out, meeting resources were provided. These included CHROSS checker pads (Bianchi, 2013), which asked a series of questions about patient presentation, with pictures to help health professionals select the correct maintenance compression hosiery; copies of the leg ulcer pathway and its treatment pathway; compression hosiery kit stock boxes; and measuring/ordering pads.
Case note review forms, along with the treatment pathway, were used on implementation to identify patients who were potentially in the wrong compression system or who could be changed to a compression hosiery kit. Of the 77 patients identified as having an active leg ulcer, 52 (68%) were changed to a compression hosiery kit, 15 (19%) remained in the correct compression bandaging, five (6.5%) patient forms were void due to incomplete information and another five (6.5%) were reviewed and the wrong clinical decision arrived at. A breakdown of this latter group identified a number of reasons: heart failure, non-tolerance of short stretch and non-tolerance of full compression.
Critically, 17 (33%) of those patients changed to a compression hosiery kit were moved from a 2-layer compression system to a European class hosiery kit in recognition of their oedema. Moving fluid in the tissues and reducing the oedema by using the correct compression can reduce the patient's risk of developing cellulitis and/or complex skin conditions.
The L&R representative attended the hub daily for the first week to solve any issues and train staff in the application of a multilayer short-stretch bandaging system and the compression hosiery kits. After this, they would visit weekly to provide support.
The case review was an important part of implementation; completed by the DN, it demonstrated the potential to improve patients' quality of life and reduce community nurse visits, thus acting as a catalyst to drive improvement in that team. After having patients and staff follow the new pathway, anecdotal feedback from the tissue viability team was that healing rates had improved, patients liked the compression hosiery kits (as they could get their shoes on) and the switch from a 2-layer compression system multilayer to a short-stretch bandaging system and a European class compression hosiery treatment kit controlled the oedema. To evidence these improvements, a case notes retrospective audit of anonymised patients was funded by L&R.
Prior to data collection, LPT's research team was consulted to ensure no ethics approval was required. Data on wound size, treatment, presence of infection and number of visits pre- and post-pathway implementation were collected. The aim was to demonstrate improved patient outcomes and clinical- and cost-efficiency after implementation of the pathway and correct compression system.
Initially, the aim was to include a maximum of 50 patients on the pathway with active leg ulceration. Due to only having launched in four hubs at the time (some within 8 weeks), this provided insufficient numbers. Therefore, two members of the tissue viability team reviewed clinic bookings and randomly selected patients who had been on the pathway for a minimum of 6 weeks. A total of 44 patients whose ulcer/s had been present for <3 months to >4 years were included in the audit. The patients were a representative sample of both county and city; there were no exclusions and ulceration sites were a mixture of gaiter, calf, medial and lateral malleoli.
The audit was completed over 3 weeks by three members of the tissue viability team and took a total of 29 hours. This was done during their personal time and paid for by L&R. The data were anonymised and submitted to an external company, Data Niche Associates, who assessed cost savings using the following assumptions: bandaging/dressing cost: £20 (double for bilateral wounds); visits cost: £50 (50% extra for bilateral wounds); compression hosiery costs: £100 (pair and spare pair), for maintenance after healing on pathway; Doppler assessment costs: £40; and GP visits: £136. The results showed that:
This audit did not capture patient feedback and experience, as it was a retrospective record review. According to the author's experience, feedback varied depending on the patient's age and motivation: younger, more dexterous patients liked the opportunity of self-caring that a compression hosiery kit offers, while older and less able patients have asked to go back to compression bandaging, due to their difficulties with compression application. To address this, the tissue viability team has reviewed donning and doffing aids, adding four to their compression formulary, as well as getting samples in clinics for patients to try and asking those companies to attend training days for staff.
It is frequently recorded that some patients may find compression hosiery kits too tight, which may be due to nurses being overcautious in compression application for fear of causing patient harm. In clinic, the author has explained to those patients that this is due to previous compression bandaging not being at optimal therapeutic level. However, community nurses will often revert to compression bandaging; this is being addressed as part of ongoing training.
Although an initial timescale of 6–8 months for implementation of the pathway and new guidelines across three CCGs (east Leicestershire and Rutland, west Leicestershire and Leicester City) was agreed, this became moveable according to how well teams picked up the new processes and treatment options. One year on, roll-out across LPT is almost complete.
More work needs to be done to improve nurses' confidence in promoting best practice and prescribing the right application aid to maximise concordance. The results of the audit highlighted many occasions where a compression hosiery kit could have been used earlier. This information has been fed back to the hub matrons and L&R's representative, with future case note reviews being planned.
Conclusion
The Lincolnshire and Leicestershire data showed how nursing time can be reduced, healing outcomes improved, costs reduced and patients' quality of life made better by implementing a standardised leg ulcer pathways with a treatment pathway to assist practitioners in the management of lower limb ulceration. These methods can help eliminate unwanted variations on leg ulcer management, ensuring that all patients are appropriately and timely assessed.