The PERCEIVE Study

NCT04903756 | Completed

• 1 other identifier: AB/136
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Peripheral Artery Disease; Diabetes Mellitus

Keywords

Major lower limb amputation; Risk perception; Shared decision making

Outcome Measures

Primary Outcomes (1)

• Analysis of audio-recorded consultations between surgeons and patients.

  Theme-oriented discourse analysis

  During primary consultation

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aneurin Bevan University Health Board: lead
• Health and Care Research Wales: collaborator

Study Sites (1)

Aneurin Bevan University Health Board

Newport, NP20 2UB, United Kingdom

Location

Related Publications (1)

• Prout H, Waldron CA, Gwilym B, Thomas-Jones E, Milosevic S, Pallmann P, Harris D, Edwards A, Twine CP, Massey I, Burton J, Stewart P, Jones S, Cox D, Bosanquet DC, Brookes-Howell L; PERCEIVE Study group; PERCEIVE Study. Challenges in shared decision-making about major lower limb amputation: the PERCEIVE qualitative study. BMJ Open. 2026 Jan 12;16(1):e104407. doi: 10.1136/bmjopen-2025-104407.

  PMID: 41526012 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: October 1, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)