PrEdiction of Risk and Communication of outcomE followIng Major Lower Limb Amputation - a collaboratiVE Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prediction of Risk and Communication of Outcome Following Major Lower Limb Amputation - a Collaborative Study (PERCEIVE). A Multi-methods Study of Risk Perception, Communication and the Extent and Experiences of Shared Decision Making Around the Time of Major Lower Limb Amputation.

Conditions
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Amputation, Peripheral Artery Disease, Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Adult patients where major lower limb amputation is being considered. | |
| Healthcare professionals<br>Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of audio-recorded consultations between surgeons and patients. | Theme-oriented discourse analysis | During primary consultation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of patient interviews | Thematic analysis of interview transcripts | As soon as possible after the time of consultation and approximately 6 months following consultation | 
| Analysis of healthcare professional interviews | Thematic analysis of interview transcripts | As soon as possible after the time of consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major lower limb amputation, Risk perception, Shared decision making