Title: A Community and Hospital cAre Bundle to improve the medical treatment of cLaudIcation and critical limb iSchaemia. The CHABLIS study.
Funder: Department of Health and Social Care

Abstract: Research question Can a bespoke intervention for patients with symptomatic Peripheral Arterial Disease (PAD) be used as part of routine NHS care? Background PAD affects one fifth of people over the age of 60. It is the commonest cause of amputation. More than half of patients with symptomatic PAD are expected to die, have an amputation or a major cardiovascular event within five years of symptom-onset. Most of their PAD and cardiovascular risk-factors are, however, modifiable. National Institute for Health and Care Excellence (NICE) guidance sets clear targets of how these risk-factors should be addressed to prevent cardiac events and reduce the need for amputation. We conducted several PPI and NHS stakeholders interviews which demonstrated very poor implementation of NICE PAD guidance, with key barriers identified in both primary and secondary care. Based on this information and the barriers identified, we developed the &ldquo;LEGS&rdquo; (LEaflet Gp letter Structured checklist) intervention. LEGS consists of checklists, doctors letters and patient leaflets and aims to support patients, General Practitioners (GPs) and hospital doctors to actively manage cardiovascular risk-factors of patients with PAD and achieve the relevant NICE treatment targets. It utilises up-to-date information based on NICE guidance, easy-to-use documents and streamlined care pathways. Aims and objectives As per Medical Research Council (MRC) and NIHR guidance for complex interventions, we aim to implement, test and potentially adapt LEGS before wider adoption across the NHS. Given the complexity of PAD care pathways across the NHS, our main aim during this project is to test intervention fidelity and acceptability using quantitative and qualitative methods (mixed methods study). Methods We will recruit patients with symptomatic PAD (claudication or chronic limb threatening ischaemia) who present to vascular clinics, diabetic foot clinics, ulcer clinics, or treated as inpatients (secondary care) in Leicestershire, South-East London and Birmingham. Data relating to intervention fidelity of delivery, acceptability, uptake, and retention will be collected over six months. Upon completion of follow-up we will conduct a consensus conference to potentially adapt the intervention and plan future research addressing clinical and cost effectiveness. Timelines Duration: 01/10/2020 - 01/10/2022 Set-up: Six months Recruitment: Six months Follow-up: Six months Analyses: Four months Consensus conference: One-day event hosted on completion of analyses Full dissemination: Two months after the consensus conference. Anticipated impact PAD is common and has a major impact on quality of life and cardiovascular morbidity. One in two patients with symptomatic PAD will suffer a major cardiovascular event or limb-loss over ten years. Less than half, however, receive appropriate care to prevent these events. The LEGS intervention, developed based on the perceptions of patients, NHS care-providers and NICE guidance, aims to address this. A 20% reduction in cardiovascular events and 10% reduction in amputations amongst patients with advanced PAD through introducing LEGS nationally, could save &pound;381 million per year in the NHS (England). This study will help us assess whether LEGS can be used in existing care-pathways, adapt it accordingly if that proves necessary, and guide future definitive research prior to NHS-wide adoption.

Lay abstract: Background Peripheral arterial disease (PAD) happens when the arteries supplying blood to the legs become narrowed or blocked. Patients with PAD may lose their leg, develop heart-attacks or strokes, or die early. Smoking, diabetes, high blood-pressure and cholesterol increase the chances of having PAD. Current NHS guidelines state that patients with PAD should be offered blood-thinners, blood-pressure, and cholesterol tablets. They should also be supported to manage their diabetes better, stop smoking, and exercise more. Our research has shown that very few patients receive this care. This leads to unnecessary deaths and amputations. When we asked patients with PAD how their NHS care could be improved, they said not enough information about PAD treatments was given. They also did not understand the high risk of heart attacks, strokes, and amputations that comes with PAD. Finally, their prescriptions were often wrong. Hospital doctors, GPs and nurses felt communication between doctors should be improved. Based on this information, we developed a bundle of doctors checklists and patients leaflets to help patients with PAD get the right treatment. We called this &ldquo;LEGS&rdquo; (LEaflet Gp letter Structured bundle). Aims In this research, we will test whether the LEGS bundle can be used in the NHS to improve the care of patients with PAD. We will then convene a conference where patients and experts will discuss whether changes to the LEGS bundle are necessary, what other research might be required in the future, and how LEGS can be adopted in the NHS. Patient & public involvement Patients have been instrumental in developing the bundle and our research. One of the research team members is a patient with PAD. Patients will take part in interviews and review study materials during the study. Study design When patients are diagnosed with PAD, we will ask doctors treating them to use the LEGS bundle. This contains key things that doctors should look-out for when treating PAD. The patient will be given a PAD information leaflet, created by patients with PAD. A letter with a list of treatments and medications will be automatically sent to patients GPs. The letter was developed by GPs to improve PAD treatments outside hospitals. We will test the LEGS bundle in three NHS regions for six months to see how well it can be used. We will also ask what patients and doctors think. This will tell us if changes are required. It will also allow us to design future research to understand whether LEGS saves lives and reduces NHS costs. Dissemination We will present results to patients and doctors nationally. We will publish findings in scientific journals and online, including plain English summaries.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR