LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK

Manoj Sivan, Trisha Greenhalgh, Julie Lorraine Darbyshire, Ghazala Mir, Rory J O'Connor, Helen Dawes, Darren Greenwood, Daryl O'Connor, Mike Horton, Stavros Petrou, Simon de Lusignan, Vasa Curcin, Erik Mayer, Alexander Casson, Ruairidh Milne, Clare Rayner, Nikki Smith, Amy Parkin, Nick Preston, Brendan Delaney, LOCOMOTION consortium, Nawar Diar Bakerly, Mauricio Barahona, Alexander Casson, Jonathan Clarke, Vasa Curcin, Helen Davies, Helen Dawes, Brendan Delaney, Carlos Echevarria, Sarah Elkin, Rachael Evans, Zaccheus Falope, Darren Greenwood Ben Glampson, Stephen Halpin, Mike Horton, Joseph Kwon, Simon de Lusignan, Gayathri Delanerolle, Erik Mayer, Harsha Master, Ruairidh Milne, Jacqui Morris, Amy Parkin, Anton Pick, Nick Preston, Amy Rebane, Emma Tucker, Ana Belen Espinosa Gonzalez, Sareeta Baley, Annette Rolls, Emily Bullock, Megan Ball, Shehnaz Bashir, Mae Mansoubi, Joanne Elwin, Denys Prociuk, Iram Qureshi, Samantha Jones, Manoj Sivan, Trisha Greenhalgh, Julie Lorraine Darbyshire, Ghazala Mir, Rory J O'Connor, Helen Dawes, Darren Greenwood, Daryl O'Connor, Mike Horton, Stavros Petrou, Simon de Lusignan, Vasa Curcin, Erik Mayer, Alexander Casson, Ruairidh Milne, Clare Rayner, Nikki Smith, Amy Parkin, Nick Preston, Brendan Delaney, LOCOMOTION consortium, Nawar Diar Bakerly, Mauricio Barahona, Alexander Casson, Jonathan Clarke, Vasa Curcin, Helen Davies, Helen Dawes, Brendan Delaney, Carlos Echevarria, Sarah Elkin, Rachael Evans, Zaccheus Falope, Darren Greenwood Ben Glampson, Stephen Halpin, Mike Horton, Joseph Kwon, Simon de Lusignan, Gayathri Delanerolle, Erik Mayer, Harsha Master, Ruairidh Milne, Jacqui Morris, Amy Parkin, Anton Pick, Nick Preston, Amy Rebane, Emma Tucker, Ana Belen Espinosa Gonzalez, Sareeta Baley, Annette Rolls, Emily Bullock, Megan Ball, Shehnaz Bashir, Mae Mansoubi, Joanne Elwin, Denys Prociuk, Iram Qureshi, Samantha Jones

Abstract

Introduction: Long COVID, a new condition whose origins and natural history are not yet fully established, currently affects 1.5 million people in the UK. Most do not have access to specialist long COVID services. We seek to optimise long COVID care both within and outside specialist clinics, including improving access, reducing inequalities, helping self-management and providing guidance and decision support for primary care. We aim to establish a 'gold standard' of care by systematically analysing current practices, iteratively improving pathways and systems of care.

Methods and analysis: This mixed-methods, multisite study is informed by the principles of applied health services research, quality improvement, co-design, outcome measurement and learning health systems. It was developed in close partnership with patients (whose stated priorities are prompt clinical assessment; evidence-based advice and treatment and help with returning to work and other roles) and with front-line clinicians. Workstreams and tasks to optimise assessment, treatment and monitoring are based in three contrasting settings: workstream 1 (qualitative research, up to 100 participants), specialist management in 10 long COVID clinics across the UK, via a quality improvement collaborative, experience-based co-design and targeted efforts to reduce inequalities of access, return to work and peer support; workstream 2 (quantitative research, up to 5000 participants), patient self-management at home, technology-supported monitoring and validation of condition-specific outcome measures and workstream 3 (quantitative research, up to 5000 participants), generalist management in primary care, harnessing electronic record data to study population phenotypes and develop evidence-based decision support, referral pathways and analysis of costs. Study governance includes an active patient advisory group.

Ethics and dissemination: LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS study is sponsored by the University of Leeds and approved by Yorkshire & The Humber-Bradford Leeds Research Ethics Committee (ref: 21/YH/0276). Participants will provide informed consent. Dissemination plans include academic and lay publications, and partnerships with national and regional policymakers.

Trial registration number: NCT05057260, ISRCTN15022307.

Keywords: COVID-19; health economics; health services administration & management; qualitative research; rehabilitation medicine.

Conflict of interest statement

Competing interests: MS is advisor to WHO for long COVID policy in Europe. TG is member of the UK long COVID national task force and member of the National Institute for Health and Care Excellence (NICE) postacute COVID guideline oversight committee and Independent SAGE member. SdeL is the Director of the Oxford-RCGP RSC (primary care surveillance network); has received grants through his University from AstraZeneca, Eli Lilly, GSK, MSD, NovoNordisk, Sanofi, Seqirus and Takeda; and has sat on advisory boards for AstraZeneca, Sanofi and Seqirus. CR Member of Society of Occupational Medicine Taskforce on long COVID; member of WHO guideline development group on rehabilitation for post-COVID condition; community representative on the Access to COVID-19 Tools Accelerator (ACT-A) committee; member of long COVID support employment group (unpaid advocacy work for workers with long COVID); and has undertaken paid work for Nestle, advising on support for employees with long COVID.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION) project workstreams (WS) and tasks. LC, long COVID; NHS, National Health Service.
Figure 2
Figure 2
Aggregate scores from a clinic population on the COVID-19 Yorkshire Rehabilitation Scale patient-reported outcome measure. (A) Mean symptom severity score of 370 patients, plotted as three subgroups (severe >6, moderate 3–5.9 and mild et al. ADL, Activities of Daily Living; PTSD, post-traumatic stress disorder.

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