1. To characterise how the COVID-19 pandemic, through changes in primary and secondary mental healthcare provision, has exacerbated ethnic inequalities in people with multimorbidities and mental disorders;
2. To identify modifiable drivers of widening ethnic inequalities for people with multimorbidities and mental disorders during/ beyond the pandemic;
3. To use findings to inform actionable recommendations, to reduce inequalities as the pandemic progresses.

Quantitative methodology

The ethically approved, Clinical Record Interactive search system (CRIS), a platform permitting free text/ structured field searches of de-identified electronic health records (EHRs), will be used^[11]. CRIS covers EHRs of South London & Maudsley (SLaM) Trust, one of Europe’s largest secondary mental healthcare providers, providing near-monopoly mental healthcare to 1.3 million residents^[11]. Half of SLaM service-users are of an ethnic minority background, with Black Caribbean, Black African, Indian, Pakistani, Bangladeshi and Irish people represented^[1]. Within CRIS, self-ascribed ethnicity has good completion (93% complete in severe mental illness (N=34,485), 88% in depression (N=43,462))^[12]. Mortality is updated weekly. COVID-19 status (testing/ clinical symptoms), is available, as are psychiatric diagnoses and physical health multimorbidities through structured fields and Natural Language Processing^{[11, 13]}.

The Clinical Practice Research Database (CPRD), is the world’s largest database of primary care EHRs^[14]. Prospective data from about 1,200 general practices across the United Kingdom from 1990-present, is available. CPRD includes information on diagnoses, specialist referrals, treatments, COVID-19 status, (testing/ clinical symptoms) and mortality. 78% of patients in CPRD have ethnicity recorded. It will be possible to assess trends in CPRD by regions (minimal regional break down will be: North East England, North West England, East Midlands, West Midlands, South East England, East of England, South West England and London)²³. We will also explore the possibility of breakdown by major cities in England with the CPRD approvals committee (e.g. London, Birmingham, Manchester).

The two datasets will complement each other and permit assessment of care pathways. Whereas CRIS provides naturalistic ethnically ‘boosted’ samples from southeast London^[11], CPRD is nationally representative^[14]. We will assess if local findings from CRIS converge/ diverge with the national context in England (CPRD). Multimorbidity will be defined as the coexistence of two or more currently active concordant or discordant mental and physical conditions. Ethnicity will be mapped to Office for National Statistics self-ascribed criteria^[1]. Across all models we will assess socioeconomic deprivation (Index of Multiple Deprivation (IMD^[15])).

Statistical analyses

To address aims 1 and 2, we will model temporal trends by ethnic groups using latent class analysis, identifying the most common clusters of multimorbidity and use these as predictors of health (mortality) and inequalities in service use, associated with the COVID-19 pandemic. We will use an interrupted time series design (pre/ post March 16th 2020, when national social distancing strategies were announced) to assess trends in service-use and deaths before/ after this time-point. We will use segmented regression analysis^[16] to compare differences in care pathways and deaths pre/ post this date. We will employ propensity score matching to adjust for confounders and multiple imputation for missing data. We will model COVID-19 exposure (diagnostic codes supplemented with tests) and outcomes/ inequalities; The implications of COVID-19 infection for the trajectory/ prognosis of multimorbidity outcomes will be examined (e.g. secondary care discharge, primary care consultations, chronic disease management, mental health reviews, deaths). We will compare outcomes in each of the ethnic minority groups with a suitable reference, using methods Das-Munshi^[17] and Becares^[18] have developed to assess ethnic inequalities. Analyses will be conducted in STATA-16 and MPLUS. As the pandemic has progressed, regional differences have become apparent (for example lock-down measures have been implemented in some regions in England but not in others). Therefore, we will also conduct analyses assessing a statistical interaction with ‘regions’ in England over time, using data from CPRD. For these analyses we will fit an interaction term to models and assess for evidence in support of a multiplicative interaction by region.

Qualitative methodology

Qualitative data collection will run concurrently with quantitative analyses.

Central to our approach is our collaboration with individuals who are involved in the Patient and Carer Race Equality Framework (PCREF) initiative. Dr Ocloo is a part of the national PCREF committee and Dr Jacqui Dyer (Chair of PCREF, the NHS England Mental Health Equalities Taskforce and Black Thrive) has also recently agreed to collaborate with us on this study. The PCREF is a framework which is being implemented in England, through NHS-England, and which seeks to directly tackle race inequalities in mental health. PCREF national approaches are to be informed by findings at three ‘pilot’ sites; these are Manchester, Birmingham & Solihull, and Lambeth (in southeast London).

We will use a participatory action research (PAR) framework²⁴, that also draws on Ocloo’s “insider-outsider” status as a lived experience researcher²¹. A PAR approach, is appropriate when seeking to solve problems and effect improvement^21,24. PAR is particularly relevant to the development of co-produced research with patients, the public and communities as it is a methodology that seeks to empower its research subjects and to create more equal partnerships in the research process^21,24. Two lived experience mental health service user researchers will be recruited through the community partnership for Black mental health, Global Black Thrive, and will work together with Ocloo to conduct semi-structured telephone/online interviews with up to 50 service users and carers, and to code and analyse all of the qualitative data. The lived experience researchers will be provided with qualitative methods training, covering good practice in conducting interviews and will also be trained on coding and thematic analysis. The interviews will be conducted remotely using methodologies which Dr Ocloo has experience of using first hand (see this webpage relating to the “Exploring the lived experiences of loneliness and isolation with people with mental health problems during the COVID 19 pandemic in the UK” study. This is a recently completed qualitative study conducted nationally by Dr Ocloo as one of the lead researchers, working with other lived experience researchers, using remote technologies and methodologies similar to those proposed here). The interviews will explore the impact of COVID-19 on accessing/ barriers to care, discrimination within health services and health-seeking, which will shed light on potential mechanisms (aim 2). Participants will be purposively sampled from three sites across England (Lambeth, Manchester and Birmingham & Solihull), by ethnicity, diagnoses and comorbidities. These sites have been selected because they are each a PCREF pilot site, therefore findings from these sites will have a direct pathway to impact nationally in England. In addition, these areas have been specifically selected as they represent areas of high ethnic diversity which have also had high rates of COVID-19 infection. Recruitment to the qualitative study will be supported through PCREF and Global Black Thrive networks as well as social media outlets. Participants will be offered the option of doing interviews either through video or audio online conferencing on Microsoft Teams or Zoom or will be able to phone into these platforms on an 0800 freephone number. All interviews will be set up by Dr Ocloo, supported by the study Research Assistant, to ensure eligibility criteria are met, with interviews recorded and saved in university password protected files.

Interviews will be de-identified, transcribed and inputted into N-Vivo. Thematic analyses will be used. A triangulation protocol will be devised to identify meta-themes and synthesise across qualitative/ quantitative findings, illuminating areas of convergence or discrepancy^[19].

Qualitative findings may highlight barriers to accessing services from the perspectives of service users (e.g. discrimination, stigma, fear of using services) which will inform interpretation^[18] and development of recommendations (aim 3).

Patient/ Stakeholder involvement

Alongside lived experience researchers being a part of the research team and contributing to data collection and analysis, we will also convene an ethnically diverse steering group of people with lived experience of mental illness and university researchers, who will be recruited from previous studies led by Ocloo and Das-Munshi^[22], convening four meetings at months 1, 5, 9, 11. The group will assist with contextualising findings and co-producing summaries and actionable recommendations (aim 3).

Investigators

The project is led by Dr Jayati Das-Munshi as Principal Investigator and supported by the following Co-Investigators: Dr Josephine Ocloo, Dr Laia Becares, Dr Alex Dregan, Prof Rob Stewart, Prof Matthew Hotopf, and Dr Jacqui Dyer