CHABLIS Study

  • Research type

    Research Study

  • Full title

    A Community and Hospital cAre Bundle to improve the medical treatment of cLaudIcation and critical limb iSchaemia

  • IRAS ID

    289220

  • Contact name

    Athanasios Saratzis

  • Contact email

    as875@leicester.ac.uk

  • Sponsor organisation

    The University of Leicester

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    Summary of Research
    Peripheral Arterial Disease (commonly referred to as PAD) is the commonest cause of amputation and a leading cause of heart problems. More than half of people found to have PAD are expected to die, have an amputation, a stroke or heart attack within five years. Many of the PAD risk-factors, such as smoking, high blood pressure, high cholesterol, high blood-sugars, can be changed when someone has the right medical care. Current doctors' guidelines for the NHS sets clear targets regarding how these risk-factors should be addressed if someone has PAD. Unfortunately, these guidelines are usually not followed in the NHS.

    To change this, we developed a bundle of checklists and letters called "LEGS" with the help of patients and experts. LEGS is meant to support patients with PAD, GPs, and hospital doctors manage the common PAD risk factors. This might help prevent amputations and other health problems in these patients.

    The aim of this study is to test how well the LEGS intervention can be used in real life at three NHS hospitals across England. With the help of patient and healthcare professional interviews (held remotely if necessary due to COVID-19), and a conference when the study finishes (remotely if necessary), there will be the opportunity to make any changes to the intervention before it is adopted across the NHS.

    This study will recruit patients referred for leg circulation assessment, either at a clinic or as an inpatient at an NHS hospital. Patients will be assessed once at 6 months, after we have used the LEGS bundle checklist and letters, to provide their original care. Their GPs will be contacted in order to review patients’ prescriptions and medical history to ensure that they received the LEGS bundle documents. We will then record how many times the LEGS bundle was used correctly.

    Summary of Results
    Background Peripheral Arterial Disease, which is commonly referred to as PAD, is a narrowing of one or more arteries (blood vessels). It mainly affects arteries that take blood to the legs and affects one fifth of people over the age of 60. Patients often experience severe pain and/or ulcers and/or gangrene, and often need admission to hospital for treatment and to see if anything can be done to improve the circulation and prevent an amputation of the leg.

    Patients with narrowing of the arteries in the leg, are also at a higher risk of developing other problems with their circulation which can result in a heart attack and/or stroke. We know that these risks can be modified using medication, stopping smoking and making lifestyle changes (diet, exercise) and although current guidelines set targets of how these risk factors should be addressed, there is little evidence that this is in fact happening.

    Aim
    The main aim of this study was to assess whether a set of documents and checklists can be used to help care for patients with PAD. In this study we also looked at the experiences of patients and healthcare professionals which will allow us to adapt these documents and checklists as per the wishes of patients, carers, and healthcare staff.

    Methods
    Over a period of one year, 120 patients from 4 NHS regions took part in the study (called CHABLIS study). These patient had pain when walking in their legs, gangrene, and/or pain at rest, due to blocked leg arteries. They were seen either in a clinic or the ward. The CHABLIS study documents and checklists were used in all cases (these documents are called the LEGS intervention). We looked at what happened to these patients over a 6 month period. We also interviewed 14 patients and 10 members of staff to ask them what they think about the study and the LEGS intervention.

    Results.
    The LEGS intervention was successfully used in around 1 out of 2 patients (64%) over the 6 month period. Patients were more likely to be on the correct medications after 6 months compared to when they originally took part in the study.

    Future directions.
    This research has shown that the LEGS intervention can be used in the NHS to care for patients who have PAD. Patients and staff in interviews expressed certain views and preferences about how the LEGS intervention can be improved, which we have used to change some the parts that make up LEGS. We now aim to test whether it does improve the overall health of patients with PAD, saves lives and prevents amputation, before taking it up across the NHS in the United Kingdom.

  • REC name

    Wales REC 7

  • REC reference

    20/WA/0319

  • Date of REC Opinion

    27 Nov 2020

  • REC opinion

    Favourable Opinion