The PERCEIVE Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-20

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.

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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.

Conditions

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Amputation Peripheral Artery Disease Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Adult patients where major lower limb amputation is being considered.

No interventions assigned to this group

Healthcare professionals

Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered.

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No