Specialised early intervention v. treatment as usual

The first Cochrane meta-analysis included three RCTs (from Denmark, Norway and England) and one cluster-RCT (from the USA) with treatment duration of 18 or 24 months. Those treated by the specialised teams had fewer hospital admissions and readmissions and fewer relapses. Hallucinations, delusions and thought disorder were less severe as were the disabling negative symptoms of psychosis such as lack of drive and motivation, blunting of emotions, social withdrawal and poverty of speech and thought. These patients had a better overall quality of life and better general functioning. They reported greater satisfaction with their care. Also, they were more likely to be in education or employment by the end of the study. ‘Recovery’, which involved a combination of symptom stability and improved social attainment, was a co-primary outcome. At the end of treatment in two of the trials, 70% of the specialised care patients were ‘in recovery’ compared with 52% of the controls (Craig et al., Reference Craig, Garety, Power, Rahaman, Colbert, Fornells-Ambrojo and Dunn2004; Grawe, Falloon, Widen, & Skogvoll, Reference Grawe, Falloon, Widen and Skogvoll2006).

The other specified primary outcome was disengagement from psychiatric services. Across three studies, 24 out of 344 (7%) patients disengaged from the specialised services; 43 of 286 (15%) disengaged from treatment as usual. The Cochrane Collaboration team considered this to be their most confident and most important finding (Puntis et al., Reference Puntis, Minichino, De Crescenzo, Cipriani, Lennox and Harrison2020b).

This conservative meta-analysis supports Correll et al.'s earlier systematic review of 10 heterogeneous RCTs (from Denmark, England, Hong Kong, Italy, Mexico, Spain and the USA) involving more than 2000 participants. There were ‘small-to-medium’ therapeutic gains across the board in clinical and social domains with specialised early intervention (Correll et al., Reference Correll, Galling, Pawar, Krivko, Bonetto, Ruggeri and Kane2018). The co-primary outcome of psychiatric hospital admission showed that 32% of the specialised care patients were hospitalised at least once compared with 42% of the control participants. Disengagement from psychiatric care was, once again, a primary outcome and favoured the specialised teams; in the combined studies, 21% discontinued treatment compared with 31% of those randomised to treatment as usual (Correll et al., Reference Correll, Galling, Pawar, Krivko, Bonetto, Ruggeri and Kane2018).

Extended specialised early intervention v. specialised early intervention + treatment as usual

In the second Cochrane meta-analysis, extended specialised intervention lasting for a total of 3 years in a trial in Hong Kong (160 participants) and for 5 years in trials in Canada and Denmark (220 and 400 participants) was compared with 2 years of early intervention followed by treatment as usual (Puntis et al., Reference Puntis, Minichino, De Crescenzo, Cipriani, Lennox and Harrison2020a). Clinically and statistically significant differences did not emerge in measures of hallucinations, delusions, thought disorder, negative symptoms, depressed mood, general functioning and education or employment status. However, satisfaction with care which was assessed only in the Danish trial (Albert et al., Reference Albert, Melau, Jensen, Emborg, Jepsen, Fagerlund and Nordentoft2017) was substantially greater with the extended treatment package. Symptom remission was used as a proxy for the co-primary outcome of ‘recovery’. The RCT in Hong Kong found 78% in remission following extended specialised care compared with 68% of those who received specialised care only for the standard 2 years (Chang et al., Reference Chang, Chan, Jim, Lau, Hui, Chan and Chen2015). The other two trials were less encouraging. In the Canadian study, 43% were in remission following 5 years of specialised care compared with 38% of those who received 2 years of specialised then 3 years of ‘regular’ care (Malla et al., Reference Malla, Joober, Iyer, Norman, Schmitz, Brown and Abadi2017). A disappointing 22.3% v. 21.6% were in remission at the end of the 5-year long Danish trial (Albert et al., Reference Albert, Melau, Jensen, Emborg, Jepsen, Fagerlund and Nordentoft2017).

The other primary outcome was disengagement from treatment. Yet again, this was the most clear and confident finding. Across two of the studies (Chang et al., Reference Chang, Chan, Jim, Lau, Hui, Chan and Chen2015; Malla et al., Reference Malla, Joober, Iyer, Norman, Schmitz, Brown and Abadi2017), 28 of 192 (15%) patients who received extended specialist care left the trials early compared with 63 of 188 (34%) control patients (Puntis et al., Reference Puntis, Minichino, De Crescenzo, Cipriani, Lennox and Harrison2020a). At the end of the Danish trial, 90% were in contact with the extended early intervention teams compared with only 56% in contact with services if they had been moved on to treatment as usual (Albert et al., Reference Albert, Melau, Jensen, Emborg, Jepsen, Fagerlund and Nordentoft2017).

It is not surprising that disengagement from treatment has been used as a pre-specified primary outcome. Early intervention specialists have proposed that ‘…the success of EI services is in part due to their emphasis on establishing and maintaining an individual's engagement with the service’ and they consider this a ‘driving philosophy’ of their approach (Birchwood, Reference Birchwood2014; Kim et al., Reference Kim, Brown, Reynolds, Geros, Sizer, Tindall and O'Donoghue2019; Tindall, Simmons, Allott, & Hamilton, Reference Tindall, Simmons, Allott and Hamilton2018). In clinical practice, every effort is made to prevent disengagement. For example, in Norfolk, Suffolk and Cambridgeshire in the East of England,

There has been splendid qualitative and quantitative research on factors that may predict disengagement (Doyle et al., Reference Doyle, Turner, Fanning, Brennan, Renwick, Lawlor and Clarke2014; Kim et al., Reference Kim, Brown, Reynolds, Geros, Sizer, Tindall and O'Donoghue2019; Mascayano et al., Reference Mascayano, Van Der Ven, Martinez-Ales, Basaraba, Jones, Lee and Dixon2020, Reference Mascayano, Van Der Ven, Martinez-Ales, Henao, Zambrano, Jones and Dixon2021; Polillo et al., Reference Polillo, Voineskos, Foussias, Kidd, Bromley, Soklaridis and Kozloff2022; Tindall et al., Reference Tindall, Simmons, Allott and Hamilton2018) and an ambitious cluster-RCT of a team-based motivational intervention to improve engagement is well underway in first-episode psychosis teams around England (Greenwood et al., Reference Greenwood, Webb, Gu, Fowler, De Visser, Bremner and Peters2021; ISRCTN registry, 2021). The importance of service engagement for this patient group is summarised well in the trial's plain language summary: ‘at least a quarter of all young people drop out of services in the first 12 months, leading to greater risk of poor health and more long-term service use. Families also struggle more’ (ISRCTN registry, 2021).

Treatment as usual

As is so often the case in health services research, there has been a lack of proper attention to ‘treatment as usual’. The published trials tend to provide only cursory descriptions. These have been drawn together by Correll et al. in a helpful supplementary table that provides some idea of what well-resourced multidisciplinary teams were compared with (Correll et al., Reference Correll, Galling, Pawar, Krivko, Bonetto, Ruggeri and Kane2018). This was mainly old-fashioned office-based appointments with a psychiatrist and/or a nurse. In the Canadian trial of extended early intervention, step-down was either to psychiatric hospital outpatient services or care from a family physician that was, according to the researchers, ‘of variable quality and intensity’ (Lutgens et al., Reference Lutgens, Iyer, Joober, Brown, Norman, Latimer and Malla2015; Malla et al., Reference Malla, Joober, Iyer, Norman, Schmitz, Brown and Abadi2017). It is worrying that, ‘[w]hile transfer to regular care was started within two weeks of randomization, it was dependent on the ability and policies of receiving services and often involved considerable delays (mean 25.7 ± 16.1 weeks)’ (Malla et al., Reference Malla, Joober, Iyer, Norman, Schmitz, Brown and Abadi2017). Another description of treatment as usual, ‘…out-patient medical follow-up with limited community support which focused mainly on crisis intervention’ (Chang et al., Reference Chang, Chan, Jim, Lau, Hui, Chan and Chen2015), encapsulates perhaps the worst imaginable – and all too common – approach to the management of people with schizophrenia and other psychoses.

Discharge from specialist early intervention services

Treatment as usual in the two British randomised trials did, at least, involve input from multidisciplinary community mental health teams (Craig et al., Reference Craig, Garety, Power, Rahaman, Colbert, Fornells-Ambrojo and Dunn2004; Kuipers, Holloway, Rabe-Hesketh, & Tennakoon, Reference Kuipers, Holloway, Rabe-Hesketh and Tennakoon2004). But this brings us to what has been happening to patients who were under the care of the early intervention for psychosis services in Oxfordshire between 2006 and 2017 (Puntis et al., Reference Puntis, Oke and Lennox2018). The average length of treatment for 701 patients was 1 year and 8 months – even though the stipulated period of involvement was 3 years. No less than 83.5% of the patients were discharged directly to their general practitioners. The remainder were transferred to other psychiatric services.

After a year, about a quarter of those who had been transferred to other psychiatric teams had relapsed; relapses in this group plateaued at close to 50% after 4–5 years. General practitioners referred almost a third of the discharged patients back to psychiatry within 2 years. About 10% of those discharged to primary care are known to have relapsed in the first year with identified relapses plateauing around 15% after about 4 years. Relapse was defined as being admitted to psychiatric hospital or being treated by the crisis resolution and home treatment teams whose role is to head off admission when this would otherwise be required. These episodes could be identified from Oxfordshire's computerised health records system. The problem with this proxy for relapse is that it misses those who deteriorate but do not come to the attention of clinicians. It is a hallmark of psychotic illnesses that insight can be impaired when patients relapse. Symptoms such as paranoid delusions can lead to active avoidance of all assistance. Loss of volition, emotional blunting and poverty of thought reduce the ability to seek help. Based on painful clinical and research experience (Boeing et al., Reference Boeing, Murray, Pelosi, McCabe, Blackwood and Wrate2007; Murray, Walker, Mitchell, & Pelosi, Reference Murray, Walker, Mitchell and Pelosi1996), we can safely assume that some of these people are sitting at home in a state of quiet neglect listening to hallucinatory voices, with kitchen drawers full of unopened packets of antipsychotic tablets and a relapse management plan that has been untouched since the day they were discharged from assertive community care. Some ex-patients will no longer have a home (Lynch, Reference Lynch2020; Marshall, Reference Marshall1989; Marshall & Gath, Reference Marshall and Gath1992).

There is wide variation in the proportion of those who are discharged from all psychiatric services by early intervention teams in England. This has been happening to 47% of patients in Leicester and 55% in Derbyshire (Ahmed, Peters, & Chakraborty, Reference Ahmed, Peters and Chakraborty2019; Phillipson, Akroyd, & Carley, Reference Phillipson, Akroyd and Carley2014). A recent article reveals that fully three-quarters were discharged by an inner-city London Trust after, on average, 28 months of care (Puntis, Whiting, Pappa, & Lennox, Reference Puntis, Whiting, Pappa and Lennox2021). A conference presentation by leaders in the field from the Birmingham and Solihull National Health Service Trust reported that this happened to 47% of patients in North-West England, 58% in Cornwall, 74% in Norfolk and 77% in Cambridge. The Birmingham and Solihull early intervention services were discharging a third of patients directly to primary care but the theme of their rather jaunty lecture was that they ‘must do better’ and increase this number (Turner & Rainey, Reference Turner and Raineyundated).

We have sought advice from colleagues working in Canada and Australia and have searched journal articles, book chapters and the ‘grey’ literature but there seems to be no equivalent available information about discharge practices in other parts of the world. We have also raised questions about this issue at online international and national conferences. Sorry to say, but there is an unfathomable complacency amongst British early intervention specialists about the fate of their erstwhile patients. We have not picked up such an attitude amongst clinicians and researchers from other countries and this is reflected in some of the published qualitative research.

Due to gaps in routine data collection, patients' discharge destinations were not documented for the recent detailed evaluation of early psychosis youth services (called headspace) around Australia (Ernst & Young Australia, 2020). However the qualitative findings are telling. Half of those patients who were aware that they were soon to be discharged ‘expressed great concern about what support would be available post discharge’.

One parent was not quite able to put all her concerns into words:

Another stated:

A patient summed up their fears as follows:

Specialist teams in North America are having to navigate the complexities in care pathways that come with various mixes of public and private health care provision and separate funding of early intervention services. One group in Halifax, Nova Scotia are discharging about a third of their patients to primary care (Tibbo, Reference Tibbo2022). They provide ongoing support to the receiving general practitioners and offer informal phone contacts to discharged patients about whom they are worried; they are understandably anxious about the adequacy of such an arrangement (Tibbo, Reference Tibbo2022). Services in New Haven, Connecticut have reported on several cycles of a quality improvement project to improve ‘this first critical hand off in care’(Gallagher et al., Reference Gallagher, Ferrara, Pollard, Yoviene Sykes, Li, Imetovski and Srihari2022). They describe good liaison with receiving clinicians. Their ongoing Plan-Do-Study-Act cycles have led, so far, to a reduction from 51% to 26% in the proportion of patients whose 3-month care status is unknown.

Jones et al. (Reference Jones, Gius, Daley, George, Rosenblatt and Shern2020) have interviewed clinicians, administrators and patients from early intervention services [which they call coordinated specialty care (CSC)] at 36 sites around the USA. They found ‘tremendous variability of discharge practices and policies…’. There were examples of excellent practice. For example, a handful of sites could provide stepped down care from patients' previous therapists and prescribers. One site had ‘clinically oriented follow-up to ensure (or assess) the success of the transition’. However, individuals who were poised to be discharged from some of the programmes expressed concerns about the fixed time limits on their participation. One of the themes that emerged from patient interviews was that,

Providers shared these concerns. In some areas, it was not possible to access ongoing care from psychiatrists who were comfortable treating psychosis and there could be difficulties ensuring continuing prescription of long-acting injectable antipsychotics and even clozapine.

These researchers provide worrying quotes from professionals and patients that nicely illustrate the theme of inadequate follow-up once separately funded CSC came to an end. Staff at one site,

The frustration of some clinicians emerged clearly:

Here we go again

The approach of time-limited resource intensive intervention followed by rapid stepdown of care has parallels with how people with schizophrenia and related psychotic illnesses were treated in the heyday of asylum care. In the UK, there was decent enough multidisciplinary care in acute admissions wards. But those who did not then remain settled with psychiatric outpatient and general practitioner appointments would end up being ‘warehoused’ in horrible and sometimes disgusting back wards of mental hospitals (Pelosi, Reference Pelosi1993). Things became even worse when moves began towards care in the community – and nobody had a clue how to deliver this (Lancet, 1985; Murphy, Reference Murphy1991; Ritchie, Dick, & Lingham, Reference Ritchie, Dick and Lingham1994). Elaine Murphy's After the Asylums, published in 1991, had a chapter entitled ‘The Disaster Years, 1962–1990’. Referring to people who had been hospitalised for years, she wrote:

It is difficult to envisage how similar scenarios in countries throughout the world could be prevented by a brief period of treatment from clinicians who specialise solely in the early stages of severe and frequently enduring mental disorders.

Ongoing care in the community

Many patients who have gone through an episode of psychosis will do well. However, others will have a prolonged and severe and sometimes a devastating illness. It is not possible accurately to predict which patients these are. We are reluctant to give advice on how to provide proper ongoing care to these people in countries where we lack knowledge and experience of their health systems. Commenting on the findings of Jones et al. (Reference Jones, Gius, Daley, George, Rosenblatt and Shern2020), Canadian clinician researchers have written an article entitled ‘Moving from islands of order to a sea of chaos: Transitions out of early intervention services for psychosis’ (McIlwaine, Fuhrer, & Shah, Reference McIlwaine, Fuhrer and Shah2020). They make practical and deliverable suggestions on improving transitions that could be relevant to countries around the world and not just in North America. However,

Nobody, we hope, will disagree with those views nor with Jones et al. (Reference Jones, Gius, Daley, George, Rosenblatt and Shern2020) when they argue that,

We are able to give advice on how these transitions should be tackled in the UK – where there can be no excuse for any patient with a known psychotic illness to be discharged to a ‘sea of chaos’. No matter how stretched they are, general adult community mental health teams in Britain should insist on taking over the management of essentially every person who has had their couple of years (or less) of ‘gold standard treatment’ (Kirkbride et al., Reference Kirkbride, Hameed, Ankireddypalli, Ioannidis, Crane, Nasir and Jones2017; Lester et al., Reference Lester, Khan, Jones, Marshall, Fowler, Amos and Birchwood2012; Puntis et al., Reference Puntis, Minichino, De Crescenzo, Cipriani, Lennox and Harrison2020a, Reference Puntis, Whiting, Pappa and Lennox2021). These teams will be faced with yet more difficult decisions about the rationing of clinical resources. But given that 10% of discharged patients in Oxfordshire are known to have relapsed within a year and a third were referred back to psychiatric services within 2 years, it is likely that community mental health teams would save themselves time and would spare many patients and families from heartache if they routinely took on ‘this first critical hand off in care’. This will allow the establishment of coordinated, individualised and needs-based community care plans – and contingency plans – that are appropriate for people with insight-impairing illnesses and that can be sustained during good times and bad over the ensuing years and decades.

Should such patients be discharged from psychiatric services immediately following a brief period of intensive input, family doctors should take control. They should write to the consultant psychiatrist in the early intervention team agreeing, as always, to shared care of their patient but refusing to accept the discharge plan. Copy letters should be sent to the catchment area consultant general psychiatrist and the medical director of the local National Health Service Trust. This letter should point out that the proposed care pathway flies in the face of clinical experience, all the research evidence, and the findings of thousands of inquiries into critical incidents and community care tragedies (Reith, Reference Reith1998; Ritchie et al., Reference Ritchie, Dick and Lingham1994).

Early intervention treatment programmes around the world have been based upon on a hypothesis that the first 3 years of illness is the critical period in the course of schizophrenia and other psychotic illnesses (Birchwood et al., Reference Birchwood, Todd and Jackson1998). This is and always was a ridiculous hypothesis. The early months and years after onset are, of course, a critical period. But everybody knows that people with schizophrenia – and schizoaffective disorder and manic-depressive psychosis and delusional disorder and other psychoses – may encounter critical times throughout their illness journey. Well-resourced, well-coordinated multidisciplinary treatment from specialist mental health clinicians is required during each and every one of these periods, with continuing care that will help to prevent them.