Award Title: STIMULATE-ICP (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways)
Funder: Department of Health and Social Care

Abstract: 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).

Lay Abstract: Long Covid is affecting over a million people in the UK. The wide-ranging symptoms are disabling, and need joined-up care from specialists, hospitals and community services. Over 80 long COVID clinics have been established but we need to better understand, diagnose and treat the disease.      We will design and test the best ways to care for people with long COVID. We will bring together six regions: Derby, Exeter, Hull, Leicester, Liverpool, and London, and include the Royal College of General Practitioners policy team, health professionals and academics.      Four patient organisations have helped to develop this proposal. They will be involved across the project from design to dissemination. To improve recovery, we will work out what long COVID is, how to diagnose it and how to manage it. The data and findings will be easily accessible to aid further research and service improvement.      We will interview patients and health professionals and analyse data from NHS records. This will inform our understanding of patterns of long COVID and the outcomes of current clinical practice. Usual care involves basic investigations such as blood tests and self-management of rehabilitation using a website https://www.yourcovidrecovery.nhs.uk/ .      We will recruit over 4,500 patients in the largest long-COVID trial to-date. We will compare a new pathway including community-based, comprehensive MRI scan (CoverscanTM) and enhanced rehabilitation (Living with COVID RecoveryTM) with usual care. We will also test different drugs, including aspirin, colchicine and loratadine/famotidine. We will measure effects of three months treatment by symptoms, mental health, return to work and other important outcomes.      With patients, we will co-develop means to improve patient access to the right care at the right time in the right place, including health professional training. We will consider the aspects of long COVID care which might improve care for patients with multimorbidity and long-term conditions.

Research Activity Codes: 6.1 PHARMACEUTICALS;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES);8.1 ORGANISATION AND DELIVERY OF SERVICES
Health Categories: INFECTION