Introduction of a new leg ulcer pathway and Urgostart dressings for venous leg ulcers in Manchester

VLU are often classified as chronic wounds with increased protease levels causing the wound to become suspended in the inflammatory stage, which leads to delayed healing⁹. Studies have also suggested that early assessment, intervention and implementation of the right dressing at the right time are essential in improving healing outcomes for patients¹.

NICE MTG42 advocates the early use of UrgoStart for VLUs, as the evidence shows that wound healing is better with this product than with a non‑interactive dressing, and thus, it has the potential to improve patient outcomes and healing rates, which in turn underpins the rationale for its adoption into practice.

It is of paramount importance that such dressings are placed correctly within the patient’s wound care journey in order to achieve the benefits stated in the studies, as there will be potential cost implications if the dressing is not used as intended ^2,3,4.

A holistic patient-centred approach is integral to achieving the goals of improved outcomes and time to healing for patients with VLUs, alongside early intervention. The implementation of a pathway can provide a structured approach and standardised care delivery; it is essential that the pathway guides the patient journey through EBP and facilitates a robust assessment, accurate interpretation of the results and suitable treatment options.

With the introduction of Urgostart dressings with the leg ulcer pathway, the Trust were hoping:

• To standardise care
• to develop a holistic pathway for leg ulcer assessment and management
• Maximise the rate of wound healing and reduce time to healing
• Ensure patients received the most effective treatment as soon as possible
• Using a cost-effective method of treating venous leg ulcers
• Holistically treating patients to improve healing outcomes by utilizing and applying evidence-based research
• Improve patients psychological state
• Correct dressing placement and avoid inappropriate use of Urgostart dressings

The challenge was to develop a leg ulcer pathway to include cost-effective, evidence-based treatment strategies to facilitate the delivery of high-quality care, guiding clinicians to improve patient healing outcomes.

A lean audit demonstrated the leg ulcer service had a high number of referrals. The audit highlighted waiting lists for clinic appointments had grown to 48 weeks as existing patients were not always progressing or being referred in a timely manner. Best practice determines that a patient with a lower limb ulcer between the knee and the ankle in the presence of venous disease must be diagnosed and treated within two weeks. The audit findings showed there was no structured approach to managing leg ulcers, dressing regimes were ad-hoc with frequent regime changes, documentation did not always reflect the progression of the wound and some patients were kept in clinic for long periods without review of the diagnosis and escalation to other specialist services. Local hospital episode statistical (HES) data was above the national average⁶.

Further to this, patient care should be patient-centric with consideration to their physical and psychological wellbeing^10,11. A patient focus group helped develop a greater understanding of how leg ulcers affected their quality of life (QoL) and helped with the development of the pathway.

The tissue viability lead nurse and a leg ulcer clinical specialist received positive feedback by tissue viability nurses through a regional shared business unit and local podiatrists when using Urgostart dressings for diabetic foot ulcers. The local pilot and clinical research evidence both also showed positive outcomes if Urgostart was placed correctly.

Historic data was compared with current data after a new pathway had been implemented. Existing formulary products such as Urgostart dressings were used (as the local formulary was not due for review).

The pathway and algorithm is now used by district nurses across south and central Manchester, with a combined population of 348,000, on all patients with a lower limb wound who present within 2 weeks of developing the wound. The use of the pathway has also been upscaled and adopted within other trusts in the northwest, such as Tameside and Glossop, Northwest Boroughs and Oldham, and it is planned for launch in Cheshire and Dudley.

Additional rationale for the leg ulcer pathway included local cost saving key performance indicators (KPI) and Commissioning for Quality and Innovation (CQUIN) targets. Within this trust, the community leg ulcer clinics in south Manchester are commissioned by the Care Commissioning Group (CCG) via a block contract with tissue viability, and KPI determines a 24-week healing target for all VLUs.

Education and guidance was offered to all wound care clinicians. This covered information on how to use the pathway, appropriate product selection at the ideal time, and for the correct duration. This was coupled with a pathway launch day. Subsequent supportive visits from the tissue viability team and clinical specialist have taken place.

To support continuity, the leg ulcer pathway was designed as a booklet for use in all settings, for example at home; in leg ulcer clinics; district nurse clinics. It now contains QoL assessment tools, a treatment algorithm guidance for use, a leg ulcer assessment form and a wound treatment chart.

The data used for the analysis had been routinely collected for many years by the tissue viability team on a leg ulcer proforma. Verbal consent for treatment and use of data was gained from the patient. Any patient with a recurrence after a period of ≥2 weeks healed were included as a separate active ulcer. The inclusion criteria was patients with a completed leg ulcer clinic proforma who met the referral criteria, had an active leg ulcer, and attended their appointments.

We compared 2 periods of 12 months, the first was before the development of the leg ulcer pathway, and the second was a period of 12 months from the implementation date of the pathway.

A separate leg ulcer clinic referral pathway was formalised >6 months before the implementation of the leg ulcer pathway. The referral pathway was created to ensure that patients who met the criteria had timely access to specialist treatment. Historically, all referrals for lower limb conditions were accepted into clinic. The outcome of allowing this increased the leg ulcer waiting lists significantly, delayed access for patients with active ulceration into the clinic and, in some cases, delayed the correct differential diagnosis for patients with other lower limb conditions, such as dermatological conditions. Simultaneously, as the appropriate referrals were enforced, patients were discharged from the leg clinic routinely if they DNA’d their clinic appointment for two consecutive weeks without due cause, or had a total of three DNAs.

The pathway was implemented as an initial 3-month pilot within the community leg ulcer clinics which are managed under the remit of the tissue viability team and led by a leg ulcer specialist nurse, who could provide relevant clinical expertise. In the treatment algorithm UrgoStart dressing is placed as a first-line dressing following the official launch of NICE MTG42.

The use of a specific leg ulcer wound chart for monitoring wound status with a visual Red, Amber and Green (RAG) triggers is used. The RAG trigger guides the nurse with decision making, prompt completion of QOL and reviews wound progression.

Results show time-to-heal has reduced and waiting lists have decreased from 48 weeks to immediate appointments. The patient journey has become more streamlined achieving full healing 45% sooner by using the pathway⁶.

Due to the pre-pathway period occurring before the implementation of the appropriate referral pathway, 39% (n=30) of the leg ulcer clinic patients did not have active leg ulcers and, consequently, only 46 of the 76 patients met the inclusion criteria for this period. During the implemented period, as the leg ulcer clinic was only accepting appropriate referrals, 32 of 39 patients met the inclusion criteria. Of those 32 patients, only 30 have been included in the analysis due to two patients commencing the pathway during the time period covered by this analysis but for <4 weeks. The excluded patient data (n=7) was lost to follow-up as patients moved out of the area, died or were admitted to hospital. 3 patients had recurring ulcers and fall into both pre- and post-pathway implementation timeframes, and 1 patient commenced treatment in the pre-pathway timeframe and healed during the post pathway timeframe. All ulcers were either mixed aetiology or VLUs.

The average time-to-healing for the initial period was 123.7 days (median: 84 days) whereas after the implementation of the leg ulcer pathway the average was 69.1 days (median: 46 days). The CCG set KPIs stating healing must be achieved within 24 weeks was achieved by all patients.

Specialist leg ulcer clinic times include 24 half-hour appointments per week, routinely managed by a band 6 specialist nurse, a band 5 nurse with the support of a band 3 healthcare assistant. Patients have an initial 60-minute assessment and subsequent 30-minute appointments accommodate removal of the bandages, washing of the limb, wound assessment, application of dressings and compression. The leg ulcer pathway booklet is completed following the dressing application.

The cost analysis has been done solely based on band 5 nurse, as this is representative of the minimum level of nurse cover required for all appointment slots. Cost for a band 5 nurse’s time per 30-minute clinic appointment is £17.83, having taken into consideration all related costs and overheads such as salary, equipment, cost of buildings and utilities etc. Cost reductions demonstrated signify the minimum savings made. Average cost per patient during the pre-pathway period was £504.99 (median: £320.88) and after the leg ulcer pathway implementation the average cost reduced to £266.51 (median: £175.72).

It is imperative that stakeholders such as specialist clinicians, nurses and healthcare providers work together to incorporate pathway into practice. The treatment algorithm has been an essential to adopting UrgoStart as the first-line treatment alongside compression when treating VLUs.

Involvement of key stakeholders at the start and throughout the journey is important to create and maintain ownership. Leg ulcer nurses and community wound care nurses and district nurses have offered ongoing education to enhance their clinical knowledge and encompass changes.

Collaborative work with the University of Manchester through the Ilumin project has been invaluable in monitoring the use of this pathway and key EBP parameters. Increasing healing rates by 6% per annum will lower the prevalence of wounds by 2020 and ultimately reduce the £3 billion spend on wound care.

With such positive results, the pathway is planned to become standardised practice across all community settings in Manchester. Within this pathway, a choice of appropriate compression systems were provided for patients with mixed aetiology or VLUs. However, the treatment algorithm that guided immediate use of the protease inhibitor for patients with comorbidities, to prevent the potential longevity of their leg ulceration can be used for all ulcer types.

Moving forward, it is hoped that referrals to the leg ulcer clinics will be reduced or expedited at a much earlier stage if specialist input is required. Further enhancements to the leg ulcer pathway document are planned, for ease of use. Further education will also be provided to support use of the pathway across a broader expanse of clinicians, reinforcing standardisation of leg ulcer care across the trust.

QoL information is now being captured every four weeks for individual patients which will allow future improvements.