The PERCEIVE Study

Completed

• Conditions: Diabetes Mellitus; Peripheral Artery Disease; Amputation

• Registration Number: NCT04903756
• Lead Sponsor: Aneurin Bevan University Health Board

Brief Summary

The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.

Detailed Description

This study will look in detail at major lower limb amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. The investigators will audio-record 10-15 consultations between surgeons and patients, examining the communication and decision-making process, and conduct individual interviews with 10-15 patients and 10-15 healthcare professionals. Patients will be interviewed at two time points: firstly as soon as possible after they discuss the possibility of leg amputation with a surgeon, and secondly around six months later. The investigators will identify what is important to patients, what information they need to make an informed decision and how best to communicate that information. Interviews with surgeons, anaesthetists and specialist physiotherapists will explore how they estimate risks and outcomes of amputation surgery, and how they communicate this to patients. Finally, the investigators will combine all this information together and discuss our findings with groups of patients and healthcare professionals, to identify key areas around amputation decision-making that can be improved and how best to further examine those areas.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Any patient aged 18 years old or over with chronic limb threatening ischaemia or diabetic foot disease for whom major lower limb amputation is considered or discussed
• Vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making

Exclusion Criteria

• Patients under 18 years old
• Patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer)
• Any patient/healthcare professional unable or unwilling to provide informed consent. Some patients undergoing emergency major lower limb amputation will have insufficient time to give informed consent
• Potential participants with an insufficient understanding of English or Welsh to be able to provide informed consent
• Potential participants unable to complete an interview in English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of audio-recorded consultations between surgeons and patients.	During primary consultation	Theme-oriented discourse analysis

Secondary Outcome Measures

Name	Time	Method
Analysis of patient interviews	As soon as possible after the time of consultation and approximately 6 months following consultation	Thematic analysis of interview transcripts
Analysis of healthcare professional interviews	As soon as possible after the time of consultation	Thematic analysis of interview transcripts

Trial Locations

Locations (1)

Aneurin Bevan University Health Board; 🇬🇧 Newport, United Kingdom