Background and rationale

In this chapter, we outline the potential benefits of digital health interventions (DHIs) to support self-management of long-term health conditions and describe the implementation challenges in reducing the gap between the potential that DHIs can deliver and what is currently available to service users and carers. We then consider the specific example of long-term mental health problems, and make the case for the need to better support relatives who care for people with psychosis or bipolar disorder. Finally, we describe the design and development of the Relatives’ Education And Coping Toolkit (REACT) and its use in this study to explore the factors affecting its implementation within early intervention for psychosis (EIP) teams in NHS trusts across England.

Digital health interventions in the NHS

Recent decades have seen a significant increase in the development and use of DHIs to support health-care delivery. DHIs can be defined as programmes that provide support and treatment for physical and/or mental health problems via a digital platform or device, for example a website or an app (an application, typically downloaded by a user to a mobile device). The support provided can be emotional, decisional and/or behavioural.1,2 Many are available directly to users through the internet or app stores, whereas others are designed to be offered as part of broader health-care packages.

In this study, we were interested specifically in the use of DHIs in supporting patients and relatives to self-manage long-term mental health conditions, although much of the rationale and learning are potentially generalisable to long-term physical health conditions. The prevalence of long-term health problems has increased as the population ages, and costs to public health services are substantial.3 By supporting people to understand their condition better, identify factors influencing the severity of symptoms, spot early signs of relapse, adopt strategies to manage these early signs and learn when and where to seek help most effectively, it is argued that we can improve the quality of life of individuals and their families, and save public money.4

The attraction of DHIs to support long-term conditions is easy to see. They offer the potential for widespread dissemination of high-quality, standardised care, accessible at the user’s convenience. Hence, they are particularly suited to rural areas and developing countries, where face-to-face service delivery can be very challenging but access to mobile technology is developing at pace.5

Self-management interventions are designed to empower users, and digital delivery offers the added potential of uniting people online to share their experiences and harness the power of peer support. Although DHI development costs can be substantial, ongoing delivery is likely to be more cost-effective than face-to-face support.

Research evidence to support the feasibility, acceptability and effectiveness of DHIs in mental health is mounting. Data exist to support the short-term benefits of web-based psychological treatments for depression and anxiety disorders, compared with waiting list controls.6,7 Online interventions are being rapidly developed for psychosis and bipolar disorder, where data support their feasibility and acceptability.8–11 For these reasons, there has been a strong policy push to develop the UK’s digital health provision.12

The implementation challenge

The successful implementation of DHIs in routine health-care services is far more limited than in research. Despite substantial investment in development, many DHIs are not adopted by their intended users, are abandoned, fail to scale up locally or spread to other settings, or are not sustained over time. The challenges can be systemic (i.e. difficulties in embedding an intervention in existing health services) or at the individual level, with low uptake levels among service users, although the two issues can be connected, for example if users feel that the intervention is not well supported by their health-care professionals.

Attempts to offer an online cognitive–behavioural therapy programme, Beating the Blues, at scale in UK mental health services13 and as part of routine care in the USA14 highlighted great difficulties in getting patients to use the programme or staff to integrate it into practice. In many ways, this is unsurprising; this is a relatively new field of enquiry and the process of change will inevitably take time. However, given the substantial implementation gap that still exists for non-digital health interventions,15 it is crucial that we do not assume that the transition from evidence to impact is inevitable. We urgently need to understand the main factors inhibiting the implementation of DHIs and use this understanding to better inform their design, evaluation, commissioning and delivery, and maximise their potential benefits.

This understanding should also mitigate the potential harm of inadequately tested DHIs, such as the increased risk of serious of breaches of confidentiality for personal and sensitive data;16 expensive information technology (IT) failures;17–19 potential increases in health inequalities;20 and lack of evidence-based commissioning, resulting in ineffective or harmful interventions being offered in clinical practice.

Psychosis and bipolar disorder

Psychosis is an umbrella term that covers many conditions, the common feature of which is a loss of touch with reality. The lifetime prevalence of a psychotic episode ranges from 5% to 7%, with the majority having only one episode.21 Approximately 0.48% of the population develop more enduring mental health problems such as schizophrenia,22 which is estimated to cost the economy of England over £5B annually.23

The most common manifestations of psychosis are believing things that are generally accepted to be untrue by other people (delusions); being unable to think clearly and so sounding muddled and confused (thought disorder); and experiencing things that are not really happening, for example hearing or seeing things that other people cannot (hallucinations).

Bipolar disorder is the third most common mental health cause of disability globally,24 affecting 1–4.5% of adults25 and costing the English economy £5.2B annually, largely due to inadequate treatment.23 Bipolar disorder is characterised by episodes of extreme low mood (depression) and extreme high or irritable mood (mania or hypomania in its milder form). Self-harm and suicidal behaviour, excessive spending, sexual disinhibition and heightened irritability can all escalate during mood episodes, and psychotic symptoms are also more likely to occur. Between episodes, functioning may return to normal levels, but many people will continue to report problematic subsyndrome levels of depression that affect their functioning and relationships.26

The need to support relatives

Relatives of people with severe mental health problems (primarily psychosis and bipolar disorder) provide the vast majority of care. This saves the NHS an estimated £1.24B per year in the UK,27 but is associated with high levels of distress in relatives;28,29 significant practical, financial and emotional burdens;30 stigma; worry; shame and guilt;31 trauma;32 and loss.33,34

Factors that increase the negative impact of psychosis on carers include being a female carer;35 living with the person with psychosis; young patient age and awareness of the patient’s suicidal ideation;36 reduced social support and family resources;36,37 use of emotion-focused coping strategies;38,39 and the beliefs that relatives hold about psychosis, particularly about its cause and control.40–42

The frequency of suicide attempts within the bipolar disorder population is higher than for many other populations affected by mental health issues, and this is a distressing situation for carers to manage.43 During periods of mania, extravagant spending, irritability and inappropriate and disproportionate behaviour become more frequent and extreme.44–46 The challenge of learning to cope with manic and depressive episodes can not only negatively affect the service user but also diminish the carer’s and their family’s quality of life, with carers expressing feelings of helplessness, anger and anxiety.47,48

It is important to note that some relatives also report positive aspects of caring for someone with a severe mental health problem, including identifying personal strengths, feeling a sense of love, caring and compassion, developing new insights about their lives and living, and greater intimacy with others as a result of their journey of coping with mental illness.49,50

Relatives of people with psychosis or bipolar disorder face many common needs. These include how best to support someone in their recovery journey; how to deal with a mental health crisis; how to manage difficult situations; how to manage stress; and how to understand and navigate mental health services and the treatments they offer.

Furthermore, mental health services are often structured such that people with a psychosis or bipolar disorder diagnosis are managed within the same teams (e.g. community mental health teams or EIP teams). Therefore, interventions to support relatives that work across these conditions make practical sense.

The Relatives’ Education And Coping Toolkit intervention

To examine in depth the major factors affecting the implementation of an online self-management toolkit for relatives of people with psychosis or bipolar disorder in UK mental health services, this study employed a multiple case study design and used the understanding gained to develop an implementation plan to support uptake and use. Through strategic use of theory to guide our data collection, analysis and interpretation, we aimed to ensure that the key factors identified, and the strategies needed to maximise successful implementation, would be generalisable to other DHIs offered within clinical teams.

The programme that formed the basis for this study was REACT, a supported self-management toolkit offered by EIP teams, providing easily accessible evidence-based information and support for relatives of people with psychosis or bipolar disorder as recommended by the National Institute for Health and Care Excellence (NICE) guidelines.51,52 It has been shown to be effective in reducing distress and improving perceived support and ability to cope in relatives of people with psychosis in EIP services.53

A comprehensive recovery-focused toolkit, REACT was originally offered in paper form to relatives of people with psychosis, with telephone and e-mail support from ‘REACT supporters’ from the clinical team. It was subsequently made available online, and broadened to cover relatives of people with bipolar disorder,54 with online support from members of the clinical team via confidential direct messaging, and from other relatives through a restricted-access forum moderated by the REACT supporters.

REACT was designed to be offered by a non-professional support worker (or equivalent) currently working in an EIP team, as it does not require highly trained health professionals, but does require experience in supporting psychosocial interventions, availability and flexibility. Importantly, support workers are relatively inexpensive, reducing cost barriers to further implementation.

In the REACT trial, one NHS trust employed and trained relatives with lived experience of supporting someone with psychosis or bipolar disorder as REACT supporters for relatives across the UK. However, for this study, serving EIP staff within each individual trust were given this role, identifying the most appropriate supporters (professional or non-professional), based on available staff resources and structure.

REACT supporters were trained for the role using standardised training materials provided online by the research team as part of our initial implementation plan. REACT contained 12 key modules, each consisting of high-quality standardised written information, videos of clinical experts or experts by experience sharing their knowledge and experiences to illustrate key points, and self-reflection tasks to ensure that content was personalised to the user. All videos of relatives telling their own stories were retold by actors to preserve anonymity. The modules included What is Psychosis?, What is Bipolar Disorder?, Managing Positive Symptoms, Managing Negative Symptoms, Managing Mood Swings, Dealing With Difficult Situations, Managing Stress (Doing Things Differently), Managing Stress (Thinking Differently), Understanding Mental Health Services, Treatment Options, Dealing With Crises and The Future.

Figure 1 is a screenshot of the home page, which outlines the modules. A full description of each is given elsewhere.55 REACT also includes a resource directory that signposts users to a wide range of relevant national and local resources. A ‘meet the team’ page ensures that relatives are fully informed about who is delivering the content of the website. Logos for the relevant NHS trust, Lancaster University, Lancashire Care NHS Trust, University College London (UCL), Liverpool Clinical Trials Research Centre (CTRC) and the McPin Foundation are prominently displayed on the log-in page. ‘Mytoolbox’ offers users a confidential space to save links to any information sources they may want to access easily in future, including specific content within the toolkit, their self-reflection tasks and external web links. A blog page offers a flexible space for additional communication with website users, which can be edited by REACT supporters. Each of the participating trusts could edit some elements of the toolkit to allow limited tailoring to their location or to a particular organisation (Table 1).

FIGURE 1 Screenshot of the REACT toolkit homepage, showing modules and features. Reproduced with permission from Lobban et al.56 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original. (Figure not reproduced here; see the original article.)

Context: early intervention for psychosis teams

This study investigated the implementation of REACT within EIP teams in NHS mental health trusts: REACT was offered online and supported by a member of the EIP team.

Early intervention for psychosis teams are part of public sector clinical services in England, providing localised early intervention (EI) support to people with early signs of psychosis and/or other severe mental health problems (including bipolar disorder). Depending on the size of the NHS trust, there may be also be further embedded units, delivering care to distinct geographically defined areas.

Early intervention for psychosis teams were established to deliver care in line with NICE guidelines51 to people during the ‘critical period’ of the first 3 years following the onset of psychosis, and to reduce the duration of untreated psychosis, which has been shown to predict long-term outcomes.57 Most teams work with people who have developed symptoms of psychotic illness for the first time for up to 3 years following their first contact with services (specific criteria vary between services). In the UK, EIP teams generally consist of a mix of psychiatrists, psychologists, care co-ordinators (social workers, community psychiatric nurses, occupational therapists) and support workers.

Although EIP services have not been immune to the funding challenges faced by all mental health services in the UK,58 they have received additional funding to facilitate the implementation of NICE guidelines and to meet the access and waiting time (AWT) standards for mental health services59,60 published in 2015 and mandated from April 2016. These standards required EIP teams to deliver eight standards, two of which were:

Where patients are in contact with their families, family members to be offered family intervention (FI).

Carers to receive focused education and support.

However, a national audit of EIP teams in England in 2016 showed poor implementation.61 Of most relevance to this study, only 50% of relatives received a carer-focused education and support programme, and only 31% were offered structured family intervention, with only 12% receiving it.61 Offering REACT was expected to help services to be compliant with the NICE Quality Standards for both psychosis (NICE Quality Standard 8062) and bipolar disorder (NICE Quality Standard 9563) by offering carers access to an education and support programme. Specifically, the guidelines recommend that carers are given written and verbal information in an accessible format about the diagnosis and management of psychosis and schizophrenia, positive outcomes and recovery, types of support for carers, role of teams and services, and getting help in a crisis.

When providing information, carers should be offered support if necessary. Importantly, REACT was not designed to replace structured face-to-face family interventions.

Relevant previous and parallel research

REACT was itself developed as part of a National Institute for Health Research (NIHR) Research for Patient Benefit-funded study to design and test the feasibility and acceptability of a self-management toolkit to support relatives of people with psychosis.64 This involved a systematic review of the literature to identify the key components of interventions that were effective in improving outcomes for carers;65 focus groups with relatives to understand their experiences and what they want from a support intervention;66,67 and a feasibility trial to determine the acceptability of the intervention, preference for type of support, rates of recruitment and retention, and an estimate of the likely effect size on a range of outcomes for relatives.53

Initially, REACT was offered as a series of paper booklets, supported by a support worker in an EIP team by e-mail or telephone. To increase accessibility, it was developed into an online intervention, and a clinical and cost-effectiveness trial was funded by NIHR under its Health Technology Assessment efficient design call for randomised controlled trials (RCTs) that tested efficient trial designs that could help address the problem of growing costs of large-scale definitive trials.68

This funding offered the opportunity to test the online REACT intervention in an entirely online trial. REACT was offered nationally online, with REACT supporters drawn from trained relatives with lived experience of supporting someone with psychosis or bipolar disorder. The aim was to test the clinical effectiveness and cost-effectiveness of REACT. Funding was awarded for 36 months with a start date of October 2015. The results of the trial have not yet been published.

In parallel, we secured funding for this study through the NIHR Health Services and Delivery Research funding stream.69 The aim was to identify the factors affecting the successful delivery of an online intervention within EIP services. In this study, REACT was offered online within a series of NHS trusts, supported by staff in the trusts’ EIP teams. Although the IMPlementation of A Relatives’ Toolkit (IMPART) study included baseline and follow-up measures of outcomes for relatives, it was not designed to test clinical effectiveness, as there was no control group that was not receiving the intervention. The focus of this study was on understanding the process of implementation. This study was funded for 30 months from March 2016.

The two studies were complementary and used the same measures and follow-up period, giving the potential to compare both the reach and the outcomes achieved by providing REACT in these very different ways. This allows us to answer questions about which is likely to be the most effective service provision model, and to compare the effectiveness of peer- and clinician-supported approaches.

Research team

Our team included UK-based relatives, clinicians [clinical psychologists, psychiatrists, general practitioners (GPs)], academics, statisticians and health economists, with a common interest in developing and evaluating new ways to support people with mental health problems and their relatives. The team in its entirety came together specifically for this project. Although team members varied in background, training, epistemological and ontological stance, some important factors underpinned their successful collaboration:

• a commitment to improving the lives of people with mental health problems and their relatives in non-stigmatising, empowering and recovery-focused ways
• a recognition of the invaluable role that relatives play in supporting people with mental health problems, and the current lack of adequate support available to them
• an interest in ensuring that evidence-based health care is delivered to service users and carers appropriately and in a timely fashion
• an interest in the challenges of implementation of complex interventions into complex organisational systems
• a commitment to identify efficient ways to carry out publicly funded research to provide value for money to the UK taxpayer.

The research was made possible by the involvement of our six participating NHS trusts. To ensure openness and transparency during data collection, we agreed to keep data confidential and to anonymise the trusts and individual participants. The six trusts were therefore allocated common bird habitats as pseudonyms, and the teams within them were named after birds likely to live within this habitat (thank you to Professor William Sellwood for this ornithological expertise).

Liverpool CTRC was extremely helpful in supporting this study. Although not funded directly, the centre supported the consent and data collection processes. It had built an online data collection infrastructure as part of the Health Technology Assessment-funded REACT trial, and adapted this for the purpose of this study.

Study management and oversight

Project Management Group

The initial Project Management Group (PMG) consisted of the grant holders who were responsible for developing the study ideas and delivering the project. This group included a relative who had spend many years supporting a family member with a diagnosis of schizophrenia (SF); two clinical academic psychologists (FL and SHJ) based in Lancaster; a clinical academic psychiatrist with a lead role nationally in EIP services (SJ) and a clinical academic GP who is director of an eHealth centre at UCL (EM); a trial statistician (CJS); a consultant clinical psychologist with a lead role in development and roll-out of EIP services (JS); the director of the McPin Foundation, which promotes service user involvement in research (VP); an internationally acclaimed expert in implementation theory and practice (JR-M); and a clinical lead for EIP teams in a local NHS trust (RS). The group met monthly via teleconference.

Additional members of the operational team based mainly in Lancaster evolved to include a lecturer in mental health with a special interest in implementation (and who joined the PMG) (NRF); two carer researchers; an IT developer (AW); five research associates over the lifetime of the project (VA, BG, EL, CM and PO); an individual who provided administrative support (BM); and two trainee clinical academics in psychiatry (GA-A) and clinical psychology (JB). They all met weekly in relation to specific tasks throughout the project and attended the PMG as required. Research associates based at the London site joined this operational meeting via teleconference.

Study Steering Group

A Study Steering Group (SSG) was appointed to oversee the project on behalf of the project sponsor (Lancaster University) and project funder (NIHR) and to ensure that the project was conducted to the rigorous standards set out in the Department of Health and Social Care’s Research Governance Framework for Health and Social Care70 and the Guidelines for Good Clinical Practice.

The group was chaired by a clinical academic and expert in the delivery of mental health interventions in the NHS (Professor David Kingdon) and included a service user or relative (this role was occupied by three people throughout the course of the study), a senior clinical academic with relevant methodological expertise in health service research, a senior NHS manager in EIP services and a representative of Lancaster University as sponsoring organisation. The SSG met before the start of the study, at the end of the pilot phase and then annually until the end of the study. All meetings took place via teleconference.

Patient and public involvement strategy

The project was designed to involve relatives at every stage and level of decision-making. The funding bid was developed with a carer who had been involved in the original REACT toolkit evaluation and who was a co-applicant on this grant. Roles were designed and costed on the independent SSG for two patient and public involvement (PPI) experts. A co-ordinating agency (the McPin Foundation) was appointed to lead on the PPI programme, drawing on experience from other studies and their involvement in the development of the original REACT toolkit. We anticipated that involving relatives would improve the delivery of the project and the experience of relatives in the research process, and ensure that findings were more effectively disseminated. PPI involvement and a reflection of the challenges around PPI are given in Appendix 1.