Clincosm LogoSign in Get a demo

Referrals for CLTI: Qualitative Study

Sponsor
University of Hull (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05659004
Collaborator
The Royal College of Surgeons of England (Other)
20
Enrollment
11.7
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Qualitative interview

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study
Anticipated Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
All participants

1 qualitative interview

Behavioral: Qualitative interview
No intervention

Outcome Measures

Primary Outcome Measures

  1. Experiences and perceptions of patients on their journey to diagnosis of CLTI [To be conducted in 2023]

    Exploring patient experience

Secondary Outcome Measures

  1. Potential improvements the process from first symptom to diagnosis of CLTI [To be conducted in 2023]

    Identifying targets for improvement work

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Hull
  • The Royal College of Surgeons of England

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Hull
ClinicalTrials.gov Identifier:
NCT05659004
Other Study ID Numbers:
  • 321794
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ischemia

Study Results

No Results Posted as of Dec 21, 2022