Work-package 1 - Mapping patient journeys and patient experiences 1.1 Objective
The objective of this work package is to:
• Explore patient journeys and patient experiences of people with dark skin tones
diagnosed with chronic venous insufficiency.
1.2 Purpose Patient journeys will be used as a catalyst for change in the identification
of CVI for people with dark skin tones. We also aim to 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.
1.3 Study design This part of the study is a qualitative interview study. This design
ensures patients experience from their perspectives are captured.
Mapping the clinical journey from the patient perspective has significant potential to
inform the redesign of new, patient centred models of care and service delivery and
understanding delays in diagnosis. The areas identified within the interviews will enable
future interventions to target failures in current clinical care and the narratives of
patient experiences captured within the interviews will also be recorded to form the
basis of trigger films or quotes that can be used within the co-design process of future
interventions using a experience-based co-design approach.
Participants will also explain how they noticed skin changes in their own skin, to aid in
the development of appropriate language and explanations of skin changes in this patient
group in an appropriate way.
To achieve the objective each consenting participant will
Participate in a semi-structured interview (approx. 1hour) exploring patient
experience and patient journey.
Self-report their skin tone using Ho and Robinson's skin tones chart, their
ethnicity, age & gender.
1.4 Participants 1.4.1 Source of participants.
Participants 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 (hospital and community settings).
Social media adverts 1.4.2 Inclusion / Exclusion Criteria inclusion criteria
people with chronic venous insufficiency, or their close family member
the person with chronic venous insufficiency has a dark skin tone (from Ho and
Robinson skin tone range 2b-6b).
ability to give informed consent exclusion criteria
person with chronic venous insufficiency has a light skin tone (from Ho and Robinson
skin tone range 1a-2a, ).
people unable to speak and understand English
people unable to give informed consent.
Work package 2 - Informing skin assessment technique and medical photography 2.1
Objective
The primary objective of this work package is to:
• Investigate the efficacy, inter-rater reliability and patient experience of skin
assessment techniques in the assessment of skin changes associated with chronic venous
disease in people with dark skin tones.
The secondary objective is to:
• determine the acceptability of undergoing these assessments from patient and nurse
perspective 2.2 Purpose To explore whether non-invasive assessment (inspection, palpation
and skin photography) techniques are appropriate to assess skin changes associated with
venous hypertension and chronic venous insufficiency in people with dark skin tones. It
will do this by providing proof-of-concept of the use of non-invasive inspection and
palpation techniques currently used in practice and techniques recommended by clinical
experts. We hope this will improve the evidence base of these techniques. It will also
provide proof of concept whether skin photography techniques can be modified to improve
skin changes associated with venous hypertension and chronic venous disease on people
with dark skin tones. This following suggestions in previous research on skin assessment
in people with dark skin tones that modifying the photographs is advantageous to assess
for erythema associated with pressure damage in the laboratory setting. However, to date
no research has considered whether this could be advantageous to assist in the detection
of skin changes associated with CVI, or could be undertaken in the clinical setting.
2.3 Study design This part of the study is an analytical cross-sectional study of 15
patients which includes reviewing participating patients clinical notes. This design
enables assessment information to be captured on participating individuals and analyse
associations with assessment data from scan results to enable proof-of-concept of skin
assessment techniques in people with dark skin tones.
To achieve this objective each consenting participant will
undergo the following:
a physical assessment of their lower legs using inspection and palpation to
determine both their clinical (C) classification of the CEAP and their Venous
Clinical Severity Score.
answer questions relating to their leg including whether they have noticed any
visual skin changes or any changes in symptoms such as pain, itching or
sensation
wound care photography under standard and enhanced photography techniques in
the medical photography studio This data will be compared to their observations
taken as part as their clinical care (such as Duplex Scan results, Consultant
Diagnosis, ABPI results, CEAP and Venous Clinical Severity Scores reported by
the clinical team).
Self-report their skin tone using Ho and Robinson's skin tones chart, their
ethnicity, age & gender.
Give their feedback during a qualitative interview of their experiences of
undergoing these clinical assessments based on relevant dimensions of acceptability
identified by Sekhon and colleagues (affective attitude, burden, ethicality,
perceived effectiveness), and report any adverse events they experienced when
undertaking these additional assessments.
The research nurse will also give their feedback of undertaking the assessments on each
patient in their structured field notes documenting relevant dimensions of acceptability
identified by Sekhon and colleagues (affective attitude, perceived effectiveness,
self-efficacy).
2.4 Participants 2.4.1 Source of participants. Participants will be recruited from a
clinical setting 2.4.2 Inclusion / Exclusion Criteria inclusion criteria
people diagnosed with chronic venous insufficiency at NHS trust
people with a dark skin tones (from Ho and Robinson skin tone range 2b-6b).
ability to give informed consent
either coming back to the hospital for surgery or being able to travel back to the
hospital to undergo physical assessment and skin photography prior to any
intervention.
have duplex scan results to show blood flow in their leg(s) exclusion criteria
person with chronic venous insufficiency has a light skin tones (from Ho and
Robinson skin tone range 1a-2a).
people unable to speak and understand English
people unable to give informed consent.