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

Background:Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. Methods:This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Results:Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. Conclusions:The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.