Referrals for CLTI: Qualitative Study

August 23, 2023 updated by: University of Hull

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambd
      • Cambridge, Cambd, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Trust
    • Yorkshire
      • Wakefield, Yorkshire, United Kingdom, WF1 4DG
        • Mid Yorkshire Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 116 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with chronic limb-threatening ischaemia in the last year

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All participants
1 qualitative interview
Behavioral: Qualitative interview
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences and perceptions of patients on their journey to diagnosis of CLTI
Time Frame: To be conducted in 2023
Exploring patient experience
To be conducted in 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential improvements the process from first symptom to diagnosis of CLTI
Time Frame: To be conducted in 2023
Identifying targets for improvement work
To be conducted in 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hull

Collaborators

The Royal College of Surgeons of England

Investigators

  • Study Director: Ian Chetter, MD, University of Hull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan; data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Limb Threatening Ischemia

Clinical Trials on Qualitative interview

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe