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

Diabetes Mellitus Clinical Trial

— PERCEIVE  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04903756
• Other study ID #: AB/136
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2022
• Source: Aneurin Bevan University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Diabetes Mellitus
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
United Kingdom	Aneurin Bevan University Health Board	Newport

Sponsors (2)

Lead Sponsor	Collaborator
Aneurin Bevan University Health Board	Health and Care Research Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of audio-recorded consultations between surgeons and patients.	Theme-oriented discourse analysis	During primary consultation
Secondary	Analysis of patient interviews	Thematic analysis of interview transcripts	As soon as possible after the time of consultation and approximately 6 months following consultation
Secondary	Analysis of healthcare professional interviews	Thematic analysis of interview transcripts	As soon as possible after the time of consultation