Introduction

Covid-19 disease results from acute SARS-CoV-2 viral infection. Whilst many patients may remain asymptomatic, or suffer self-limiting disease, symptoms persist in some for an extended period. Long Covid “occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms, and that last for at least 2 months and cannot be explained by an alternative diagnosis” [1]. It spans multiple healthcare challenges, including physical and psychological symptoms and functional impairment that may be episodic for some and unrelenting for others. It has been estimated that up to 12% of non-hospitalised individuals with COVID-19 may have persistent symptoms for more than 3 months [2]. The nature of the illness, together with its prevalence [3], suggests that Long Covid results in a significant individual, health care system, and societal burden [4–9] which may challenge the delivery of effective, high-quality and sustainable care.

Despite a growing patient population, there is no evidence-based treatment or rehabilitation intervention for Long Covid. Further, non-hospitalised patients and assessments of clinical care pathways have been under-represented in the few Long Covid clinical trials or longitudinal cohort studies so far reported [10]. The epidemiology, clinical trajectory, healthcare utilisation and effectiveness of current care for Long Covid are thus poorly documented [11, 12]. Currently in England, there are fewer than 90 specialist Long Covid clinics in which assessment and treatment is informed by NICE guidelines. However, there is evidence that access to such clinics and related care pathways, the nature of those pathways, and patient experience, varies [13]. Research is thus required to inform diagnosis, care, public health strategies, policy planning, resource allocation and budgeting. It is likewise essential to define the usual care pathway in Long Covid clinics, and to understand patient presentation, and the efficacy and cost of care.

It is important to understand how access to Long Covid services varies, and the barriers to such access and thus to diagnosis and subsequent care. Early evidence suggests that systemic inequalities in referral, assessment and rehabilitation may exist, exacerbated in part by stigma towards specific Long Covid population subgroups, based on demographic or socioeconomic characteristics [7]. It is thus important to document and understand these inequalities and how they relate to pre-pandemic health inequalities, in the new contexts of NHS pressures causing additional pressures on access, such that all patients have access to appropriate care at the right time.

Funded by the National Institute for Health Research (NIHR), the STIMULATE-ICP (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways) project combines clinical and epidemiological studies; a large randomised controlled trial (RCT) exploring the benefit of an integrated care pathway (ICP) for Long Covid; and mixed methods studies exploring inequalities of care and transferability of the ICP to other long-term conditions (LTCs).

This protocol is for the sub-study, STIMULATE-ICP-CAREINEQUAL, which will provide much needed evidence regarding the nature of usual care, the outcomes such care delivers, costs of such care, and inequalities which currently exist with respect to accessing care. Findings will help inform development and delivery of effective and equitable case identification, support management and treatment for Long Covid.

Materials and methods

In order to collect and analyse data in the most pragmatic and effective and timely manner, we opted for a mixed methods approach to address these research questions. An overview of the research components, data collection methods and analyses are set out in Fig 1. Patients and health professionals will be interviewed to understand their experience and document how the clinics function, while patient data from Long Covid clinics will be explored to understand the nature of Long Covid and the care received. A follow up survey of patients will provide an understanding of the outcomes of care and the cost.

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Fig 1. Study design for the CARE-INEQUAL work package for STIMULATE-ICP.

https://doi.org/10.1371/journal.pone.0271978.g001

Patient and public involvement

STIMULATE-ICP has been enriched by robust patient and public involvement and engagement (PPIE). Each of our work packages has a PPIE co-lead, alongside clinical and academic co-leads, and PPIE features in our regular management and oversight meetings. In the work packages set out in this protocol, PPIE members have contributed to the research components, including informing the questionnaire design and approach to interviews, and will continue to be involved in the analysis plan and dissemination of findings.

Dissemination and outputs

The final dissemination plan is to be decided by the PPIE group members and the study Co-Is. However, dissemination will include publications, conference presentations, engagement with media and updates/publication on our study website (https://www.stimulate-icp.org/). Research participants will receive publications and reports generated by the study if they wish and where possible. In addition, we will disseminate via PPIE meetings during and at the end of the project.

Discussion

As Long Covid is a new and emerging disease with a growing prevalence, it is paramount not only that efficacious treatments are developed, but that we also better understand the patient population, current care pathways, and the determinants of access to care, and thus ultimately inform effective guideline development. STIMULATE-ICP-CAREINEQUAL aims to address this evidence gap by describing current Long Covid care in the six initial clinics participating in the STIMULATE-ICP study and to understand potential barriers and facilitators to access to care.

There are currently fewer than 90 Long Covid clinics in England, with a variety of configurations according to local expertise. Rapid guidelines were produced in late 2020, with further policy published in June 2021, and funding to expand services beyond assessment to diagnostics and treatment [15]. However, many individuals seem to have been unable to access services, with long waiting lists [16] and temporary suspension of clinics in some areas over the 21/22 winter period contributing to this [17]. By undertaking this research, we will describe patient and clinician experiences of real-world barriers and facilitators to delivery and access of Long Covid services in a variety of service designs.

The strengths of this study include an inter-disciplinary approach, with patients, clinicians and qualitative and quantitative researchers involvement in the study design and execution. The six sites participating in the STIMULATE-ICP trial demonstrate a variety of service settings, design and duration; representing the diversity of Long Covid services in England. However, this may also be a challenge–both to the recruitment of participants, and to accessing baseline and quality patient data for our proposed analyses.

This study will provide insights into the deliverability of holistic Long Covid services; the impact of such services on health and care practitioners and Long Covid patients; the cost; and inequities in access. Further research is being undertaken within the broader project in order to make recommendations on improving access to Long Covid services. The data collected within this protocol will enrich the findings of the STIMULATE-ICP trial, which will explore the benefits of an integrated care pathway (ICP) for Long Covid and inform the STIMULATE-ICP-DELPHI sub-study [18], by providing a context for the implementation of any recommendations.

Acknowledgments

HM is supported by the National Institute for Health Research’s (NIHR’s) Comprehensive Biomedical Research Centre (BRC) at University College London Hospitals (UCLH).

MG is supported by the National Institute for Health and Social Care Research Applied Research Collaboration North West Coast (ARC NWC).

This paper has been published on behalf of the STIMULATE-ICP Consortium: Professor Amitava Banerjee (Chief Investigator), Professor Paula Lorgelly, Professor Elizabeth Murray, Dr Hakim-Moulay Dehbi, Professor Hugh Montgomery, Dr Yi Mu, Sarah Clegg, Dr Mel Ramasawmy–University College London; Dr Melissa Heightman (Co-Chief Investigator), Dr Toby Hillman, Dr Emma Wall, Dr Michael Zandi—University College London Hospitals NHS Foundation Trust; Professor Dame Caroline Watkins, Denise Forshaw, Dr Gordon Prescott–University of Central Lancashire; Dr Gail Allsopp—Derbyshire NHS Foundation Trust/Royal College of General Practitioners; Professor Mark Gabbay, Professor Gregory Lip, Professor Dan Cuthbertson, Dr Dan Wootton, Professor Nefyn Williams—University of Liverpool; Dr Michael Crooks—University of Hull; Dr Angela Green—Hull University Teaching Hospitals Trust; Professor Christina van der Feltz-Cornelis, Dr Jennifer Sweetman, Dr Han-I Wang, Natalie Smith—University of York; Professor Kamlesh Khunti—University of Leicester; Dr David Strain—University of Exeter; Dr Emily Attree, Jasmine Hayer, Rachel Hext, Lyth Hishmeh, Kim Horstmanshof, Mag Leahy, Antony Loveless, Clare Loveless, Rita Mallinson Cookson, Andrew Williams, Rachel Williams–PPI Representatives; Dr Nisreen Alwan, Dr Donna Clutterbuck—University of Southampton; Dr Marija Pantelic—University of Sussex; Chris Robson—Living With COVID Recovery; Professor Sir Mike Brady, Dr Rajarshi Banerjee, Dr Cat Kelly–Perspectum. An up-to-date version of Consortium members can be found: https://www.stimulate-icp.org/team. STIMULATE-ICP can be contacted at: info@stimulate-icp.org

Disclaimer: The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health and Social Care Research or the Department for Health and Social Care.