About this trial
The aim of this project is to define assessment criteria for chronic venous insufficiency (CVI) in people with dark skin tones. It will inform future interventions and modifications to practice for the assessment of CVI in people with dark skin tones in a nurse led intervention to improve patient assessment.
To achieve this there will be two parts to this study.
1. We will explore patient journeys and patient experiences of people with dark skin tones diagnosed with chronic venous insufficiency. From this we will learn from people with dark skin tones about how they recognised skin changes in their lower legs to further inform clinical assessment guidance and techniques. We will also listen to their patient journey to identify what areas worked well and what could be developed. This will help us plan how care could be improved for similar people. 2. We will record how skin changes look and feel in people with dark skin tones and known venous disease, and photograph this. We will consider whether some additional techniques used in practice to look and feel the skin is useful and whether changing the colour balance and manipulating the photographs is useful to see these skin changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
the person with chronic venous insufficiency has a dark skin tone (from Ho and Robinson skin tone range 2b-6b, table 1).
ability to give informed consent Participant
Disqualifiers
person with chronic venous insufficiency has a light skin tone (from Ho and Robinson skin tone range 1a-2a, table 1).
people unable to speak and understand English
people unable to give informed consent.
people diagnosed with chronic venous insufficiency at NHS trust
Trial population
Work-package 1 - Mapping patient journeys and patient experiences Source of participants. People with with chronic venous insufficiency, or their close family member, will be recruited from any of the following : * through charity organisations such as the "Lyndsey Leg Club Foundation". Publicity for recruitment will be available by adverts circulated through their members lists, on social media or as in person posters at events. * people who have previously expressed interest in being involved in research on leg ulcers/ venous insufficiency who have a dark skin tone. * Clinical settings (community or acute setting). Work package 2 - Informing skin assessment technique and medical photography Source of participants. Participants will be recruited from clinical settings within our trust partner organization. This NHS Foundation Trust is the hub of the southeast Thames vascular network, based in London, UK.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Work-package 1 - Patient experience
No quantitative outcomes will be assessed in the interview study to map patient journey and patient experience.
Work package 2 - Skin assessment of the lower limb
the clinical researcher / research nurse will follow guidance on assessing the skin in people with dark skin tones. The current guidance on this includes using touch (palpation) as well as visualising skin changes to feel for any temperature change or tightness, and asking the patient whether they have noticed any changes in appearance of have any symptoms such as pain, itching or sensation changes. Al In addition to the assessments recommended in existing clinical guidelines, there is an indication from our recent qualitative interviews with specialist staff, some clinicians have refined their skills and techniques to assist them to undertake, what they perceive to be, a more accurate assessment on people with dark skin tones. This includes several techniques that have not been reported elsewhere including the use of transillumination and extending the skin to visualize changes. All these assessments will be reported for each patient.
Work package 2 - Clinical (C) classification of the CEAP
This assessment will be based on the Clinical (C) classification of the CEAP, which is the most widely used tool for venous disease classification and recommended by international guidelines. These may not be readily observed in patients with dark skin tones, especially by non-specialist clinicians. The clinical researcher / research nurse will base their clinical interpretation of CEAP score based on their assessments of skin changes. Individual observations will be reported alongside the classification assigned. This scale denotes clinical classification of skin changes from C0 (no visible or palpable signs of venous disease) to C6 (an active venous ulcer).
Work package 2 - Venous Clinical Severity Score
This is a a widely used tool for rating clinical severity which guidance suggests should be considered in research on venous disease. The clinical researcher / research nurse will base their clinical interpretation of each component of the venous clinical severity score based on their assessments of skin changes and patient assessment. Individual observations will be reported alongside the classifications assigned. This scale scores several components such as pain, varicose veins, venous oedema, pigmentation, inflammation, induration, active ulcers, use of compression. Each question can score between 0 and 3 points, where more points equates to more severe.
Secondary outcomes
Work package 2 - Patient experience
Patient perspective of undertaking these assessments. It will explore what they felt of these assessments to ensure patients feel these assessments are appropriate, they felt these are effective and whether they caused any unnecessary discomfort or inconvenience. Data will be collected qualitatively to capture patients perceptions, feelings and opinions.
Work package 2 - Clinican experience
Give their feedback of undertaking the assessments on each patient in their structured field notes
Sponsors and contacts
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King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
University of Surrey
Collaborator