ACP discussions in patients' decision making during LVAD consultation

  • Research type

    Research Study

  • Full title

    Including Advance care planning (ACP) discussions in patients' decision making during consultation about Left Ventricular Assisted Device (LVAD) implantation.

  • IRAS ID

    310309

  • Contact name

    Maya Nair

  • Contact email

    m.nair@bolton.ac.uk

  • Sponsor organisation

    University Of Bolton

  • Clinicaltrials.gov Identifier

    22/PR/1287, PR Committee

  • Duration of Study in the UK

    1 years, 0 months, 7 days

  • Research summary


    Heart Transplant is the gold standard treatment for patients in heart failure however scarcity of organs have made it difficult for patient’s to obtain the organ before they deteriorate irreversibly. Therefore the development of Left Ventricular Assisted Device (LVAD) in 1980s brought some hope to these patients. It provides mechanical circulatory support to the failing Heart by buying time until the new Heart is available, called a ‘bridge to transplant’ (BTT) or at times as the last resort called as a Destination therapy (DT), for patients with chronic end stage Heart failure.
    LVAD has been used in England since circa 2011 and has been commissioned via the National Health Service (NHS), it is only approved for BTT and not for DT in contrast to some other countries.
    Patients do not remain on an urgent heart transplant list as their condition improves whilst they are on LVAD. However, it is also found that some patients deteriorate whilst on LVAD and they eventually become unfit for the transplant and thus BTT could change to DT. Whilst patients and families are informed about their future with LVAD, it is of paramount importance that the information and choice of their treatment and care should be discussed and explored. This is especially the case if they are in the last phase of their life. A lack of such discussions and decisions has posed ethical challenges amongst health care professionals (hcps) and family members about surrounding a clear indication about a patient’s choices when seeking to provide a dignified death.
    A gap in enquiry has been identified relating to Advance Care Planning (ACP) practice surrounding consultation about LVAD insertion.
    The study will examine stakeholder perspectives (patients, carers and hcps) of including ACP discussions around informed decision-making during LVAD consultation.
    The design of choice of this study is Mixed Methods as a quantitative and qualitative approach is combined here with data collection in two stages:
    Stage 1: is a mixed method survey of hcps views on inclusion of ACP discussions before LVAD implantation
    Stage 2: is individual interviews with hcps/patients/carers about discussions on their views of inclusion of ACP discussions before LVAD implantation.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    22/EM/0278

  • Date of REC Opinion

    15 Dec 2022

  • REC opinion

    Unfavourable Opinion