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

Sponsor
Aneurin Bevan University Health Board (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04903756
Collaborator
Health and Care Research Wales (Other)
30
Enrollment
1
Location
13.5
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Anticipated Study Start Date :
    Jun 16, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Analysis of audio-recorded consultations between surgeons and patients. [During primary consultation]

      Theme-oriented discourse analysis

    Secondary Outcome Measures

    1. Analysis of patient interviews [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 [As soon as possible after the time of consultation]

      Thematic analysis of interview transcripts

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aneurin Bevan University Health Board Newport United Kingdom NP20 2UB

    Sponsors and Collaborators

    • Aneurin Bevan University Health Board
    • Health and Care Research Wales

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brenig Llwyd Gwilym, Mr, Aneurin Bevan University Health Board
    ClinicalTrials.gov Identifier:
    NCT04903756
    Other Study ID Numbers:
    • AB/136
    First Posted:
    May 27, 2021
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brenig Llwyd Gwilym, Mr, Aneurin Bevan University Health Board
    Major lower limb amputation
    Risk perception
    Shared decision making
    Additional relevant MeSH terms:
    Peripheral Arterial Disease

    Study Results

    No Results Posted as of May 27, 2021