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Completed

NCT Number: NCT04903756

The PERCEIVE Study

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: During primary consultation

    Theme-oriented discourse analysis

Secondary outcomes

  1. Analysis of patient interviews

    Time frame: As soon as possible after the time of consultation and approximately 6 months following consultation

    Thematic analysis of interview transcripts

  2. Analysis of healthcare professional interviews

    Time frame: As soon as possible after the time of consultation

    Thematic analysis of interview transcripts

Sponsors and collaborators

Lead sponsor

Aneurin Bevan University Health Board

Other

Collaborators

  • Health and Care Research Wales

Registry information

Official study 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.

Acronym: PERCEIVE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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