STIMULATE-ICP (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways)

Background: Long COVID clinics are being implemented as usual care, but clinical characteristics, effective management strategies, recovery pathways, resource needs, and equitable access remain ill-defined. Aim: To develop integrated care pathways (ICPs) for long COVID, and to evaluate effectiveness and cost-effectiveness, compared with usual care. Methods: We will define optimal long COVID care pathways (investigation, treatment, rehabilitation) in an adaptive, 2-year programme with three work packages involving: long COVID clinics in six regions; patient support groups; policymakers; specialist health professionals and academics in long COVID and integrated care. First, we will study patient trajectories, healthcare utilisation, effectiveness and cost of usual long COVID care using: (i)UK linked national records(n=56 million); (ii)prospective cohort study of non-hospitalised long COVID(n=500); (iii)long COVID clinics (n=6); (iv)qualitative interviews(n=30); and (v)”deep phenotyping”(e.g. omics, imaging, physiology) of common symptom groupings(n=300). Second, in a pragmatic cluster (primary care network-level)-randomised trial, we will evaluate ICPs with early, supported investigation (multi-organ MRI with CoverscanTM and clinical decision support) and enhanced rehabilitation (Living with COVID RecoveryTM), compared with usual care(basic investigations and YourCOVIDRecoveryTM self-management), recruiting adults with suspected long COVID at referral(n=4520). In a nested, multi-arm, randomised (patient-level) drug trial, we will assess aspirin, colchicine and loratidine/famotidine versus standard of care. Primary outcome is fatigue assessment scale at three months. We will develop a long COVID core outcome dataset for research and assess cost-effectiveness of interventions. Third, with patients, we will co-develop interventions (enhanced case-finding) to improve access to care and support. In long COVID clinics, our trials and national data, we will investigate inequalities by geographic location, socioeconomic status, ethnicity and pandemic stage. Outputs for long COVID policy and research include: (i)evaluation of current care and clinical trajectory; (ii)effective and equitable care pathways, transferable to other long-term conditions; (iii)platform for future trials; and (iv)biobank for investigating outcome and treatment response(~5000).