Referrals for CLTI: Qualitative Study

Chronic Limb Threatening Ischemia Clinical Trial

Official title:

The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659004
• Other study ID #: 321794
• Status: Completed
• Start date: January 10, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: August 2023
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are:

• What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment

• What is important to patients during this process.

Participants will be interviewed and their words analysed using reflexive thematic analysis.

Description:

There are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients. There is currently limited national and international guidance on how and when to refer patients with suspected CLTI to specialist vascular surgery services. The use of qualitative interviews will allow us explore perceptions and experiences of patients with CLTI being referred to vascular surgery services, and identify possible ways to improve the process via interviews. This study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for CLTI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• CLTI diagnosed in the last year

Exclusion Criteria:

• Lacking capacity to consent to interview

• Potential to be violent

• Cognitive impairment

• Non-English speaking

Related Conditions & MeSH terms

• Chronic Limb Threatening Ischemia
• Chronic Limb-Threatening Ischemia
• Ischemia

Intervention

Behavioral:
• Qualitative interview
No intervention

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Trust	Cambridge	Cambd
United Kingdom	Mid Yorkshire Hospitals NHS Trust	Wakefield	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences and perceptions of patients on their journey to diagnosis of CLTI	Exploring patient experience	To be conducted in 2023
Secondary	Potential improvements the process from first symptom to diagnosis of CLTI	Identifying targets for improvement work	To be conducted in 2023