The PERCEIVE Study (PERCEIVE)

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Amputation; Peripheral Artery Disease

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Newport, United Kingdom, NP20 2UB
    • Aneurin Bevan University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria apply. All queries about participant eligibility should be directed to the Qualitative Researcher. We will purposively sample participants from up to four participating NHS Health Boards / Trusts in Wales and England. We will aim to include 8-10 surgeons, 1-3 anaesthetists and 1-3 specialist physiotherapists from several Health Boards / Trusts. We will purposively sample patients for inclusion in the audio-recorded consultations and interviews to ensure our sample has variation in terms of gender, age, MLLA type (above knee/below knee/no amputation) and Health Board / Trust.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients; Adult patients where major lower limb amputation is being considered.
Healthcare professionals; 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?

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

Collaborators and Investigators

• Sponsor: Aneurin Bevan University Health Board
• Collaborators: Health and Care Research Wales

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Shared decision making; Risk perception; Major lower limb amputation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: AB/136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No