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

Cohort study, UK-only, Multi-centre
Primary Investigator: Athanasios Saratzis
Funding: NIHR
Sponsor: University of Leicester
Start date: 01/05/2021
End date: 30/10/2021

Prospective feasibility multicentre cohort study

The study includes adult patients with incapacitating intermittent claudication or chronic limb threatening ischaemia (Rutherford stages 3–6), that are referred to secondary care, either in a clinic or for inpatient treatment, as well as healthcare professionals who provide care to patients with have symptomatic peripheral arterial disease.

The intervention used in this research is called “LEGS”. It was developed by patients and experts in peripheral arterial disease. It addresses the five key treatment areas identified in our review of best available evidence and clinical guidelines, including National Institute for Health and Care Excellence (NICE) guidance: lipid control, antiplatelet therapy, blood pressure control, smoking cessation, and blood-glucose control. The aim is to improve the medical care of patients with peripheral arterial disease by using the LEGS intervention.

The LEGS intervention consists of:
i) Inpatient doctors’ checklist: One-page checklist for patients admitted in a hospital setting. The list is filled initially with the first patient clerking (on admission) by the relevant doctor and then immediately before discharge (last day of inpatient stay).
ii) Outpatient doctors’ checklist: One-page checklist for those seen in a clinic. The list is filled in during the outpatient consultation, prompting the doctor or nurse to address all BMT key areas.
iii) LEGS leaflet for patients and relatives (both inpatients and outpatients): a concise leaflet which covers the implications of a diagnosis of PAD and the key treatment targets of NICE guidance, given to the patient upon the diagnosis of symptomatic PAD either during their inpatient stay or at the outpatient consultation.
iv) LEGS GP letter: a standardised letter with specific action points that cover the main aspects of Best Medical Therapy for PAD, sent to the patient’s GP immediately after discharge from hospital (inpatients) or after each clinic visit (outpatient).
v) LEGS GP follow-up letter: a follow-up letter will be sent automatically to the GP 4 weeks after each contact with secondary care (inpatient stay/clinic visit), again prompting action for NICE treatment targets.

Follow-up is 6 months.

Primary outcome measure:

Number of elements of the LEGS intervention delivered successfully by the clinical team measured using patient records at day of discharge/day of clinic appointment and 15 days later.

Secondary outcome measures:

1. Has the participant been made aware of the diagnosis of peripheral arterial disease and whether relevant medications have been prescribed? (yes/no) by contacting the primary care surgery at day 15
2. Patient medication history from day 0 to 6 months, measured using patient records
3. Health events from day 0 to 6 months, measured using patient records
4. Quality of life measured using the EuroQol-5D (EQ-5D) questionnaire at 6 months

Participating centres:

Glenfield Hospital – University Hospitals of Leicester NHS Trust

St Thomas’ Hospital – Guy’s and St Thomas’ NHS Foundation Trust

Walsgrave General Hospital – University Hospitals Coventry and Warwickshire NHS Trust

Russells Hall Hospital – The Dudley Group NHS Foundation Trust

Contact: ame29@le.ac.uk