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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Analysis of audio-recorded consultations between surgeons and patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Analysis of audio-recorded consultations between surgeons and patients.
时间窗: During primary consultation
Theme-oriented discourse analysis
次要结局
- Analysis of patient interviews(As soon as possible after the time of consultation and approximately 6 months following consultation)
- Analysis of healthcare professional interviews(As soon as possible after the time of consultation)
研究者
Brenig Llwyd Gwilym
Mr
Aneurin Bevan University Health Board
