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Background Despite the effectiveness of cognitive remediation, it is not widely implemented because we do not know whether teams will accept it, how much therapist time is needed, whether there are factors which predict lower benefits, whether it is cost-effective and what is required for large-scale roll-out. Objective To understand the factors that will enhance implementation and benefits of cognitive remediation in Early Intervention Services. Design Four work packages: (1) focus groups and interviews exploring the development of satisfaction and preference measures for staff and service users; participant team interviews to collect data, before and after introducing cognitive remediation, to understand team dynamics; (2) an observational study of a newly developed therapist e-training programme; (3) a multiarm multistage four-arm randomised controlled trial comparing different amounts of therapist input with Treatment as Usual; and (4) an analysis of trial data to understand potential mediating and moderating factors that affect treatment benefits. Setting Early Intervention Services in the United Kingdom National Health Service. Participants Staff and service users in touch with Early Intervention Services. Interventions For the e-training, we piloted and then provided an e-learning system for training cognitive remediation therapists. For the randomised trial, we provided a cognitive remediation software programme (CIRCuiTS™,King’s College London, London) that was delivered in three conditions, all offering up to 42 sessions of cognitive remediation. The conditions were: Intensive (one to one with a therapist), Group treatment with a therapist, Independent with drop-in sessions. Main outcome measures Work package 1: We developed two satisfaction measures and tested a team dynamic model. Work package 2: Feasibility and acceptability questionnaire, time to complete e-training modules. Work package 3: The personal recovery measure – Goal Attainment Scale. Results Work package 1: The service user satisfaction with cognitive remediation was reliable and valid. Although it did not show statistically significant differences between the arms of the trial, the most preferred methods (Group and Intensive) had higher associated satisfaction. Team leadership and especially a flattened hierarchy, resources and time were identified as vital for implementation. Our team dynamic model supported the importance of leadership in influencing organisational climate, which then affected staff attitudes. However, this was only significant before staff had any experience of their patients receiving cognitive remediation. Although the sample was much smaller after therapy, this may indicate that experience of the beneficial therapy changes team dynamics. Work package 2: The e-training modules were completed by 43% of the recruited participants. They judged the training to be feasible and acceptable, but it did take longer to complete than expected. COVID-19 with the increased workload may have had some effects, but our data exploration shows that it was individuals who had most recently qualified who had the best outcomes. This may be because of a lighter workload or that they were more used to online training. Adaptations suggested are now being implemented. Work package 3: Following the interim analysis we closed two arms – Independent therapy and Treatment as Usual. Four hundred and forty-eight patients consented and 377 were eligible and completed baseline assessment. They were randomised: Group 134, Independent 65, Intensive 112 and Treatment as Usual 66. At post therapy, there were no differences between Group and Intensive or between Independent and Treatment as Usual, but the combined Group and Intensive versus Treatment as Usual was significant (mean difference: 5.734; standard error = 1.958; p = 0.003; lower confidence interval = 1.898 to upper confidence interval = 9.571). Our economic analysis showed that Group and Intensive cognitive remediation were not different with respect to quality-adjusted life-years (difference £150, 95% confidence interval –£1132 to £1905). Both conferred significant benefit compared with standard care (Group and Treatment as Usual: difference £257, 95% confidence interval –£1694 to £2615; Intensive vs. Treatment as Usual: difference £260, 95% CI –£1654 to £2239). Their cost–benefit for quality-adjusted life-year improvement was well below the National Institute for Health and Care Excellence threshold for adopting the intervention to National Health Service services. Work package 4: Cognition had a small mediation effect, and negative symptoms moderated the transfer of cognitive benefits to goal attainment. Limitations The trial suffered from recruitment difficulties which were overcome when we switched from block to individual randomisation. The final target was large enough to test our main outcomes and moderating and mediating variables. Conclusions Cognitive remediation should be provided in the National Health Service, involving a trained therapist on a Group or Intensive format with team and training support. Future work We have a large database and will continue to investigate factors that affect cognitive remediation benefits. Study registration This study is registered as ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0612-20002) and is published in full in Programme Grants for Applied Research; Vol. 12, No. 4. See the NIHR funding and Awards website for further award information. Plain language summary Cognitive problems in people with schizophrenia predict functional recovery even with the best-possible rehabilitation opportunities. One psychological treatment, cognitive remediation can improve both cognitive and functional recovery, such as in social relationships and occupational achievements. We investigated the optimal way of delivering computerised cognitive remediation in Early Intervention Services by incorporating service user and staff views. Our work involved exploring what treatment factors are important to service users, developing two bespoke cognitive remediation satisfaction measures for service users and service providers. Our investigation of team dynamics suggested that a more flexible leadership style together with increasing resources might be most suited to successful delivery. One challenge for large-scale roll-out of cognitive remediation is therapist training opportunities, so we developed an online programme and then tested it in the United Kingdom and, with a few adaptations, it can be provided to the National Health Service. Although cognitive remediation is effective, we do not know how much therapist time produces therapy benefits, so we conducted a trial comparing three options for cognitive remediation treatment that differed in the amount of the therapist time (Independent, Group and Intensive). We compared these options with a no-treatment group. We investigated benefits of each option in 377 participants from Early Intervention Services. The main benefit assessed was whether participants could achieve their personal goals that were set before therapy began. Although we found no change in a social or occupational functioning scale rated by an observer, the Group and Intensive cognitive remediation produced significant achievements in the participants’ own personal goals compared with those who did not receive therapy or who carried out therapy on their own. We also found that any cognitive remediation therapy option improved thinking skills. Group and Intensive therapy were also cost-effective. Overall, cognitive remediation was acceptable and well liked by service users, so all our data suggest that it should be more easily accessible in the National Health Service. Scientific summary Cognitive remediation (CR) therapy is a psychological intervention targeting cognitive dysfunction associated with psychosis with the goal of improving functional outcomes. Cognitive remediation can improve cognitive and functional recovery, as well as increasing confidence and motivation. Evidence from the largest meta-analysis demonstrated that these effects are durable. National Health Service Early Intervention for psychosis services provide care soon after a diagnosis of psychosis to optimise recovery. Embedding CR in those services may confer long-lasting benefits such as improved social relationships and the opportunity to work or take part in further education. The overarching aim of the Enhancing Cognition and quality of Life in early PSychosiEs (ECLIPSE) research programme was to determine the optimal method of introducing computerised CR therapy (CIRCuiTS™) into NHS Early Intervention Services (EIS) considering improvement in cognitive and social function and cost-effectiveness. The programme was centred on work package 3 (WP3), a randomised, blinded multiarm multisite controlled trial comparing three CR implementation methods with each other and with routine clinical care [Treatment as Usual (TAU)]. To aid the interpretation of WP3 and bolster our recommendations to the NHS, WP1 included a series of studies investigating: patient and staff satisfaction with CR; preference for the methods of CR delivery; and the influence of team organisational climate. Although the CR was computerised and can be completed independently, its effects are boosted via learning, practice and feedback supervised by a therapist. WP2 was a series of studies to design and test an online CR therapist training package to use in their individual teams. Finally, WP4 examined mediators and moderators of the trial results to inform teams about how the clinical features of their individual patients may influence the effect of CR. In WP3, the CR modalities were: Intensive 1 : 1 therapist supervision; Group supervision with one therapist; and Independent (self-determined with infrequent access to therapist supervision). Participants were recruited from EIS in 12 mental health trusts, linked to 6 universities and serving diverse urban/rural populations. They were clinically stable and presented with a non-affective psychotic episode not

Background Poor adherence to photoprotection from ultraviolet radiation in the rare disease xeroderma pigmentosum can be life-threatening due to heightened risk of skin cancers. This novel, two-phase research programme used mixed methods to investigate photoprotection in xeroderma pigmentosum, and its psychosocial impact, to develop an intervention to improve photoprotection. Objective(s) Phase I: To identify barriers to optimal photoprotection. Phase II: To design and test a personalised psychological intervention to improve photoprotection. Design Phase I: Interview study; n-of-1 photoprotection study; objective measurement of ultraviolet radiation exposure study; international cross-sectional survey. Phase II: Consensus conference to synthesise findings and determine targets/priorities for intervention; intervention development using Intervention mapping; randomised controlled trial to test efficacy, cost-effectiveness and intervention mechanisms. Settings for Phases I and II National Xeroderma Pigmentosum Service, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom; Specialist xeroderma pigmentosum clinics in Regensburg, Germany, Japan, Tunisia; Patient support organisations in France and USA. Participants Children < 16 (Phase I only) and adults (> 16) diagnosed with xeroderma pigmentosum. Intervention (Phase II) XPAND is a seven-session personalised psychological intervention designed to be facilitated by non-psychologists, delivered in spring to summer 2018 versus wait list control (intervention in spring to summer 2019). Main trial outcome measure (Phase II) Average daily ultraviolet radiation dose to the face calculated by combining objective ultraviolet radiation exposure with self-reported photoprotection. Results Phase I: Varying levels of photoprotection were found, with most participants doing less than clinically recommended. The international survey (N = 156) and estimation of ultraviolet radiation dose-to-face (N = 41) found that adults had worse photoprotection than the ‘cared for’ sample, but that overall the total dose-to-face was similar in the two groups because the ‘cared for’ group were outside more. The n-of-1 study (N = 20) showed that fluctuations in protection were associated with time of day, weekday versus weekend, environmental risk perceptions and symptoms resulting from exposure, self-regulatory and psychological constructs. The qualitative study (N = 25) identified three modes of adaptation to photoprotection: (1) ‘dominated’, (2)‘integrated’ and (3) ‘resistant’. Modifiable drivers of photoprotection behaviour were identified in the survey studies, including belief-based predictors and the important role of habits. These combined findings informed the development and targets of the XPAND intervention. Phase II: The intervention group (n = 6) had significantly lower daily average ultraviolet radiation dose-to-face (primary outcome) compared to control (n = 7) (−0.25 Standard Erythemal Dose, p 16 years with a confirmed diagnosis of XP, sufficient English language comprehension and no cognitive impairment completed the measures themselves. Parents/caregivers of children (

BackgroundInterest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. ObjectiveWe aim to explore patients’ and clinicians’ perspectives of the utility and real-world application of PRMs to improve the management of CRS. MethodsFocus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. ResultsBoth clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. ConclusionsFindings from this study provide information on clinicians’ and patients’ perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. Trial RegistrationClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081

Background: Depression is common in patients with coronary heart disease (CHD) but the relationship is uncertain. In the UK, general practitioners (GPs) have been remunerated for finding depression in CHD patients; however, it is unclear how to manage these patients. Objectives: Our aim was to explore the relationship between CHD and depression in a GP population and to develop nurse-led personalised care (PC) for patients with CHD and depression. Design: The UPBEAT-UK study consisted of four related studies. A cohort study of patients from CHD registers to explore the relationship between CHD and depression. A metasynthesis of relevant literature and two qualitative studies [patients’ perspectives and GP/practice nurse (PN) views on management of CHD and depression] helped develop an intervention. A pilot randomised controlled trial (RCT) of PC was conducted. Setting: Thirty-three GP surgeries in south London. Participants: Adult patients on GP CHD registers. Interventions: From the qualitative studies, we developed nurse-led PC, combining case management and self-management theory. Following biopsychosocial assessment, a PC plan was devised for each patient with chest pain and depressive symptoms. Nurses helped patients address their most important related problems. Use of existing resources was promoted. Nurse time was conserved through telephone follow-up. Main outcome measures: The main outcome of the pilot study of our newly developed PC for people with depression and CHD was to assess the acceptability and feasibility of the intervention and to decide on the best outcome measures. Depression, measured by the Hospital Anxiety and Depression Scale – depression subscale, and chest pain, measured by the Rose angina questionnaire, were the main outcome measures for the feasibility and cohort studies. Cardiac outcomes in the cohort study included: attendance at rapid access chest pain clinics, stent insertion, bypass graft surgery, myocardial infarction and cardiovascular death. Service use and costs were measured and linked to quality-adjusted life-years (QALYs). Data for the pilot RCT were obtained by research assistants from patient interviews at baseline, 1, 6 and 12 months for the pilot RCT and at baseline and 6-monthly interviews for up to 36 months for the cohort study, using standard questionnaires. Results: Personalised care was acceptable to patients and proved feasible. The reporting of chest pain in the intervention group was half that of the control group at 6 months, and this reduction was maintained at 1 year. There was also a small improvement in self-efficacy measures in the intervention group at 12 months. Anxiety was more prevalent than depression in our CHD cohort over the 3 years. Nearly half of the cohort complained of chest pain at outset, with two-thirds of these being suggestive of angina. Baseline exertional chest pain (suggestive of angina), anxiety and depression were independent predictors of adverse cardiac outcome. Psychosocial factors predicted the continued reporting of exertional chest pain across the 3 years of follow-up. Costs were slightly lower for the PC group but QALYs were also lower. Neither difference was statistically significant. Conclusions: Chest pain, anxiety, depression and social problems are common in patients on CHD registers in primary care and predict adverse cardiac outcomes. Together they pose a complex management problem for GPs and PNs. Our pilot trial of PC suggests a promising approach for treatment of these patients. Generalisation is limited because of the selection bias in recruitment of the practices and the subsequent participation rate of the CHD register patients, and the fact that the research took place in south London boroughs. Future work should explicitly explore methods for effective implementation of the intervention, including staff training needs and changes to practice. Trial registration: Current Controlled Trials ISRCTN21615909. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 4, No. 8. See the NIHR Journals Library website for further project information.

Abstract Background Inpatient psychiatric care is unpopular and expensive, and development and evaluation of alternatives is a long-standing policy and research priority around the world. In England, the three main models documented over the past fifty years (teams offering crisis assessment and treatment at home; acute day units; and residential crisis services in the community) have recently been augmented by several new service models. These are intended to enhance choice and flexibility within catchment area acute care systems, but remain largely undocumented in the research literature. We therefore aimed to describe the types and distribution of crisis care models across England through a national survey. Methods We carried out comprehensive mapping of crisis resolution teams (CRTs) using previous surveys, websites and multiple official data sources. Managers of CRTs were invited to participate as key informants who were familiar with the provision and organisation of crisis care services within their catchment area. The survey could be completed online or via telephone interview with a researcher, and elicited details about types of crisis care delivered in the local catchment area. Results We mapped a total of 200 adult CRTs and completed the survey with 184 (92%). Of the 200 mapped adult CRTs, there was a local (i.e., within the adult CRT catchment area) children and young persons CRT for 84 (42%), and an older adults CRT for 73 (37%). While all but one health region in England provided CRTs for working age adults, there was high variability regarding provision of all other community crisis service models and system configurations. Crisis cafes, street triage teams and separate crisis assessment services have all proliferated since a similar survey in 2016, while provision of acute day units has reduced. Conclusions The composition of catchment area crisis systems varies greatly across England and popularity of models seems unrelated to strength of evidence. A group of emerging crisis care models with varying functions within service systems are increasingly prevalent: they have potential to offer greater choice and flexibility in managing crises, but an evidence base regarding impact on service user experiences and outcomes is yet to be established.

Background: Across England, around 60,000 people live in mental health supported accommodation: residential care, supported housing and floating outreach. Residential care and supported housing provide on-site support (residential care provides the highest level), whereas floating outreach staff visit people living in their own tenancies. Despite their abundance, little is known about the quality and outcomes of these services. Objectives: The aim was to assess the quality, costs and effectiveness of mental health supported accommodation services in England. The objectives were (1) to adapt the Quality Indicator for Rehabilitative Care (QuIRC) and the Client Assessment of Treatment scale for use in mental health supported accommodation services; (2) to assess the quality and costs of these services in England and the proportion of people who ‘move on’ to less supported accommodation without placement breakdown (e.g. to move from residential care to supported housing or supported housing to floating outreach, or, for those receiving floating outreach, to manage with fewer hours of support); (3) to identify service and service user factors (including costs) associated with greater quality of life, autonomy and successful move-on; and (4) to carry out a feasibility trial to assess the required sample size and appropriate outcomes for a randomised evaluation of two existing models of supported accommodation. Design: Objective 1 – focus groups with staff (n = 12) and service users (n = 16); psychometric testing in 52 services, repeated in 87 services (adapted QuIRC) and with 618 service users (adapted Client Assessment of Treatment scale). Objectives 2 and 3 – national survey and prospective cohort study involving 87 services (residential care, n = 22; supported housing, n = 35; floating outreach, n = 30) and 619 service users followed over 30 months; qualitative interviews with 30 staff and 30 service users. Objective 4 – individually randomised, parallel-group feasibility trial in three centres. Setting: English mental health supported accommodation services. Participants: Staff and users of mental health supported accomodation services. Interventions: Feasibility trial involved two existing models of supported accommodation: supported housing and floating outreach. Main outcome measures: Cohort study – proportion of participants who successfully moved to less supported accommodation at 30 months’ follow-up without placement breakdown. Feasibility trial – participant recruitment and withdrawal rates. Results: The adapted QuIRC [QuIRC: Supported Accomodation (QuIRC-SA)] had excellent inter-rater reliability, and exploratory factor analysis confirmed its structural validity (all items loaded onto the relevant domain at the > ± 0.3 level). The adapted Client Assessment of Treatment for Supported Accommodation had good internal consistency (Cronbach’s alpha 0.89) and convergent validity (rs = 0.369; p

Background: Despite the movement towards care in the community, 40% of the NHS budget on mental health care is still attributed to inpatient services. However, long before the Francis Report highlighted grave shortcomings in inpatient care, there were reports by service user groups on the poor quality of these services in mental health. The programme provides a particular focus on the inclusion of the patient’s perspective in the development and evaluation of evidence. Objectives: To understand how changes to inpatient care affect the perceptions of the ward by service users and staff by using stakeholder participatory methods. Design: The programme consisted of four work packages (WPs). (1) Lasting Improvements for Acute Inpatient SEttings (LIAISE): using participatory methods we developed two new scales [Views On Therapeutic Environment (VOTE) for staff and Views On Inpatient CarE (VOICE) for service users]. (2) Client Services Receipt Inventory – Inpatient (CITRINE): working with nurses and service users we developed a health economic measure of the amount of contact service users have with staff. The self-report measure records interactions with staff as well as the number of therapeutic activities attended. (3) Delivering Opportunities for Recovery (DOORWAYS): a stepped-wedge randomised controlled trial to test if training ward nurses to deliver therapeutic group activities would improve the perception of the ward by service users and staff. A total of 16 wards were progressively randomised and we compared the VOICE, VOTE and CITRINE measures before and after the intervention. A total of 1108 service users and 539 staff participated in this trial. (4) Bringing Emergency TreatmenT to Early Resolution (BETTER PATHWAYS) was an observational study comparing two service systems. The first was a ‘triage’ system in which service users were admitted to the triage ward and then either transferred to their locality wards or discharged back into the community within 7 days. The second system was routine care. We collected data from 454 service users and 284 nurses on their perceptions of the wards. Main outcome measures: The main outcomes for the DOORWAYS and BETTER project were service user and staff perceptions of the ward (VOICE and VOTE, respectively) and the health economic measure was CITRINE. All were developed in WPs 1 and 2. Results: We developed reliable and valid measures of (1) the perceptions of inpatient care from the perspectives of service users and nurses (VOICE and VOTE) and (2) costs of interactions that were valued by service users (CITRINE). In the DOORWAYS project, after adjusting for legal status, we found weak evidence for benefit (standardised effect of –0.18, 95% CI 0.38 improvement to 0.01 deterioration; p = 0.062). There was only a significant benefit for involuntary patients following the staff training (N582, standardised effect of –0.35, 95% CI –0.57 to –0.12; p = 0.002; interaction p-value 0.006). VOTE scores did not change over time (standardised effect size of 0.04, 95% CI –0.09 to 0.18; p = 0.54). We found no evidence of an improvement in cost-effectiveness (estimated effect of £33, 95% CI –£91 to £146; p = 0.602), but resource allocation did change towards patient-perceived meaningful contacts by an average of £12 (95% CI –£76 to £98; p = 0·774). There were no significant differences between the triage and routine models of admission in terms of better perceptions by service users (estimated effect 0.77-point improvement in VOICE score on the triage ward; p = 0.68) or nurses (estimated effect of 1.68-point deterioration in VOTE on the triage ward; p = 0.38) or in terms of the cost of the length of care provided (£391 higher on triage; p = 0.77). Strengths and limitations: We have developed measures using methods involving both service users and staff from mental health services. The measures were developed specifically for acute inpatient services and, therefore, cannot be assumed to be useful for other services. For instance, extensions of the measures are under construction for use in mother and baby units. The strength of the BETTER PATHWAYS and DOORWAYS projects is the large-scale data collection. However, we were testing specific services based in inner city areas and stretching to inner urban areas. It may be that different effects would be found in more rural communities or in different types of inpatient care. Future work: Our database will be used to develop an understanding of the mediating and moderating factors for improving care quality. Trial registration: Current Controlled Trials ISRCTN06545047. Funding: This project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 6, No. 7. See the NIHR Journals Library website for further project information.

Background: Seclusion (the isolation of a patient in a locked room) and transfer to a psychiatric intensive care unit (PICU; a specialised higher-security ward with higher staffing levels) are two common methods for the management of disturbed patient behaviour within acute psychiatric hospitals. Some hospitals do not have seclusion rooms or easy access to an on-site PICU. It is not known how these differences affect patient management and outcomes. Objectives: To (1) assess the factors associated with the use of seclusion and PICU care, (2) estimate the consequences of the use of these on subsequent violence and costs (study 1) and (3) describe differences in the management of disturbed patient behaviour related to differential availability (study 2). Design: The electronic patient record system at one trust was used to compare outcomes for patients who were and were not subject to seclusion or a PICU, controlling for variables, including recent behaviours. A cost-effectiveness analysis was performed (study 1). Nursing staff at eight hospitals with differing access to seclusion and a PICU completed attitudinal measures, a video test on restraint-use timing and an interview about the escalation pathway for the management of disturbed behaviour at their hospital. Analyses examined how results differed by access to PICU and seclusion (study 2). Participants: Patients on acute wards or PICUs in one NHS trust during the period 2008–13 (study 1) and nursing staff at eight randomly selected hospitals in England, with varying access to seclusion and to a PICU (study 2). Main outcome measures: Aggression, violence and cost (study 1), and utilisation, speed of use and attitudes to the full range of containment methods (study 2). Results: Patients subject to seclusion or held in a PICU were more likely than those who were not to be aggressive afterwards, and costs of care were higher, but this was probably because of selection bias. We could not derive satisfactory estimates of the causal effect of either intervention, but it appeared that it would be feasible to do so for seclusion based on an enriched sample of untreated controls (study 1). Hospitals without seclusion rooms used more rapid tranquillisation, nursing of the patient in a side room accompanied by staff and seclusion using an ordinary room (study 2). Staff at hospitals without seclusion rated it as less acceptable and were slower to initiate manual restraint. Hospitals without an on-site PICU used more seclusion, de-escalation and within-eyesight observation. Limitations: Official record systems may be subject to recording biases and crucial variables may not be recorded (study 1). Interviews were complex, difficult, constrained by the need for standardisation and collected in small numbers at each hospital (study 2). Conclusions: Closing seclusion rooms and/or restricting PICU access does not appear to reduce the overall levels of containment, as substitution of other methods occurs. Services considering expanding access to seclusion or to a PICU should do so with caution. More evaluative research using stronger designs is required. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background: The REAL (Rehabilitation Effectiveness for Activities for Life) research programme, funded by the National Institute for Heath Research (NIHR) from 2009 to 2015, investigated NHS mental health rehabiliation services across England. The users of these services are people with longer-term, complex mental health problems, such as schizophrenia, who have additional problems that complicate recovery. Although only around 10% of people with severe mental illness require inpatient rehabilitation, because of the severity and complexity of their problems they cost 25–50% of the total mental health budget. Despite this, there has been little research to help clinicians and commissioners to plan and deliver effective treatments and services. This research aimed to address this gap. Methods: The programme had four phases. (1) A national survey, using quantitative and qualitative methods, was used to provide a detailed understanding of the scope and quality of NHS mental health rehabilitation services in England and the characteristics of those who use them. (2) We developed a training intervention for staff of NHS inpatient mental health rehabilitation units to facilitate service users’ activities. (3) The clinical effectiveness and cost-effectiveness of the staff training programme was evaluated through a cluster randomised controlled trial involving 40 units that scored below average on our quality assessment tool in the national survey. A qualitative process evaluation and a realistic evaluation were carried out to inform our findings further. (4) A naturalistic cohort study was carried out involving 349 service users of 50 units that scored above average on our quality assessment tool in the national survey, who were followed up over 12 months. Factors associated with better clinical outcomes were investigated through exploratory analyses. Results: Most NHS trusts provided inpatient mental health rehabilitation services. The quality of care provided was higher than that in similar facilities across Europe and was positively associated with service users’ autonomy. Our cluster trial did not find our staff training intervention to be clinically effective [coefficient 1.44, 95% confidence interval (CI) –1.35 to 4.24]; staff appeared to revert to previous practices once the training team left the unit. Our realistic review suggested that greater supervision and senior staff support could help to address this. Over half of the service users in our cohort study were successfully discharged from hospital over 12 months. Factors associated with this were service users’ activity levels [odds ratio (OR) 1.03, 95% CI 1.01 to 1.05] and social skills (OR 1.13, 95% CI 1.04 to 1.24), and the ‘recovery’ orientation of the unit (OR 1.04, 95% CI 1.00 to 1.08), which includes collaborative care planning with service users and holding hope for their progress. Quality of care was not associated with costs of care. A relatively small investment (£67 per service user per month) was required to achieve the improvement in everyday functioning that we found in our cohort study. Conclusions: People who require inpatient mental health rehabilitation are a ‘low-volume, high-needs’ group. Despite this, these services are able to successfully discharge most to the community within 18 months. Our results suggest that this may be facilitated by recovery-orientated practice that promotes service users’ activities and social skills. Further research is needed to identify effective interventions that enhance such practice to deliver these outcomes. Our research provides evidence that NHS inpatient mental health rehabilitation services deliver high-quality care that successfully supports service users with complex needs in their recovery. Main limitation: Our programme included only NHS, non-secure, inpatient mental health rehabilitation services. Trial registration: Current Controlled Trials ISRCTN25898179. Funding: The NIHR Programme Grants for Applied Research programme.

Background: At least 100,000 patients with schizophrenia receive care from community mental health teams (CMHTs) in England. These patients have regular meetings with clinicians, who assess them, engage them in treatment and co-ordinate care. As these routine meetings are not commonly guided by research evidence, a new intervention, DIALOG, was previously designed to structure consultations. Using a hand-held computer, clinicians asked patients to rate their satisfaction with eight life domains and three treatment aspects, and to indicate whether or not additional help was needed in each area, with responses being graphically displayed and compared with previous ratings. In a European multicentre trial, the intervention improved patients’ quality of life over a 1-year period. The current programme builds on this research by further developing DIALOG in the UK. Research questions: (1) How can the practical procedure of the intervention be improved, including the software used and the design of the user interface? (2) How can elements of resource-oriented interventions be incorporated into a clinician manual and training programme for a new, more extensive ‘DIALOG+’ intervention? (3) How effective and cost-effective is the new DIALOG+ intervention in improving treatment outcomes for patients with schizophrenia or a related disorder? (4) What are the views of patients and clinicians regarding the new DIALOG+ intervention? Methods: We produced new software on a tablet computer for CMHTs in the NHS, informed by analysis of videos of DIALOG sessions from the original trial and six focus groups with 18 patients with psychosis. We developed the new ‘DIALOG+’ intervention in consultation with experts, incorporating principles of solution-focused therapy when responding to patients’ ratings and specifying the procedure in a manual and training programme for clinicians. We conducted an exploratory cluster randomised controlled trial with 49 clinicians and 179 patients with psychosis in East London NHS Foundation Trust, comparing DIALOG+ with an active control. Clinicians working as care co-ordinators in CMHTs (along with their patients) were cluster randomised 1 : 1 to either DIALOG+ or treatment as usual plus an active control, to prevent contamination. Intervention and control were to be administered monthly for 6 months, with data collected at baseline and at 3, 6 and 12 months following randomisation. The primary outcome was subjective quality of life as measured on the Manchester Short Assessment of Quality of Life; secondary outcomes were also measured. We also established the cost-effectiveness of the DIALOG intervention using data from the Client Service Receipt Inventory, which records patients’ retrospective reports of using health- and social-care services, including hospital services, outpatient services and medication, in the 3 months prior to each time point. Data were supplemented by the clinical notes in patients’ medical records to improve accuracy. We conducted an exploratory thematic analysis of 16 video-recorded DIALOG+ sessions and measured adherence in these videos using a specially developed adherence scale. We conducted focus groups with patients (n = 19) and clinicians (n = 19) about their experiences of the intervention, and conducted thematic analyses. We disseminated the findings and made the application (app), manual and training freely available, as well as producing a protocol for a definitive trial. Results: Patients receiving the new intervention showed more favourable quality of life in the DIALOG+ group after 3 months (effect size: Cohen’s d = 0.34), after 6 months (Cohen’s d = 0.29) and after 12 months (Cohen’s d = 0.34). An analysis of video-recorded DIALOG+ sessions showed inconsistent implementation, with adherence to the intervention being a little over half of the possible score. Patients and clinicians from the DIALOG+ arm of the trial reported many positive experiences with the intervention, including better self-expression and improved efficiency of meetings. Difficulties reported with the intervention were addressed by further refining the DIALOG+ manual and training. Cost-effectiveness analyses found a 72% likelihood that the intervention both improved outcomes and saved costs. Limitations: The research was conducted solely in urban east London, meaning that the results may not be broadly generalisable to other settings. Conclusions: (1) Although services might consider adopting DIALOG+ based on the existing evidence, a definitive trial appears warranted; (2) applying DIALOG+ to patient groups with other mental disorders may be considered, and to groups with physical health problems; (3) a more flexible use with variable intervals might help to make the intervention even more acceptable and effective; (4) more process evaluation is required to identify what mechanisms precisely are involved in the improvements seen in the intervention group in the trial; and (5) what appears to make DIALOG+ effective is that it is not a separate treatment and not a technology that is administered by a specialist; rather, it changes and utilises the existing therapeutic relationship between patients and clinicians in CMHTs to initiate positive change, helping the patients to improve their quality of life. Future research: Future studies should include a definitive trial on DIALOG+ and test the effectiveness of the intervention with other populations, such as people with depression. Trial registration: Current Controlled Trials ISRCTN34757603. Funding: The National Institute for Health Research Programme Grants for Applied Research programme.

Background: The transition from prison to community is difficult for prisoners with mental illness. Critical time intervention (CTI) is designed to provide intensive support to meet health, social care and resettlement needs through close working between client and key worker pre, and up to 6 weeks post, release. Objectives: To establish whether or not CTI is effective in (1) improving engagement of discharged male prisoners who have mental illness with community mental health teams (CMHTs) and (2) providing practical support with housing, finance and re-establishing social networks. Trial design: A multicentre, parallel-group randomised controlled trial, with follow-up at 6 weeks and at 6 and 12 months. A subset of prisoners and case managers participated in a complementary qualitative study. Setting: Eight English prisons. Participants: One hundred and fifty adult male prisoners, convicted or remanded, cared for by mental health in-reach teams and diagnosed with severe mental illness, with a discharge date within 6 months of the point of recruitment. Intervention: Participants were randomised to either the intervention or the control (treatment as usual). The intervention group was assigned a case manager who assessed mental and physical health before and following release, made appropriate links to health, housing and financial services and supported the re-establishment of family/peer contact. Outcome: The primary outcome measure was engagement with a CMHT 6 weeks post discharge. Secondary outcomes included contact with mental health services at 6 and 12 months. A health economic evaluation was undertaken using service contact at the follow-up time points. We were unable to assess the intervention’s effect on reoffending and longer-term health-care use because of study delays. Results: One hundred and fifty prisoners were recruited: 72 were randomised to the intervention and 78 were randomised to the control. Engagement with teams at 6 weeks was 53% for the intervention group compared with 27% for the control group [95% confidence interval (CI) 0.13% to 0.78%; p = 0.012]. At 6 months’ follow-up, intervention participants showed continued increase in engagement with teams compared with control participants (95% CI 0.12% to 0.89%; p = 0.029); there were no significant differences at 12 months. Increased engagement resulted in higher levels of service use and costs for the intervention than for the control. Qualitative data showed the intervention group reporting better continuity of care and improved access to services. Conclusion: The intervention significantly improved contact with services at 6 weeks, although at a higher cost than the control. This is important as, in the days and weeks following release, recently released individuals are at a particularly high risk of suicide and drug overdose. Further research is required to establish how teams can better maintain contact with clients when the intervention ends. Future work: Further studies are indicated for groups with different needs, for example women, young prisoners and those in police custody, and at other transition points, for example following arrest and short-term custody, and at points of transition between different mental health services. Trial registration: Current Controlled Trials ISRCTN98067793. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 5, No. 8. See the NIHR Journals Library website for further project information.

Background: This study focuses on health care received by people with serious mental illness (SMI). The aim is to examine the economic implications of different locations of management of care and the views of service users and staff regarding services set up as alternatives to secondary care. Objectives: Specific objectives are to (1) identify people with SMI managed in primary or secondary care; (2) identify those who could be potentially transferred to primary care; (3) compare the characteristics of these groups; (4) compare service use and costs; (5) generate models to estimate cost changes following transfer between settings; (6) identify characteristics associated with time to transition to secondary care; (7) investigate experiences of patients receiving support from community-based interventions; and (8) assess the economic impact of interventions to facilitate transfer of care management. Methods: (1) Quantitative component – using linked primary and secondary care data we examined differences between those discharged to primary care (n = 1410) and those still in secondary care (n = 1629). Service use and costs were compared and predictors of costs were identified using regression models. (2) Qualitative component – interviews following a topic guide were conducted at two time points with 31 people using and 10 people working in services set up as alternatives to secondary care. (3) Economic modelling – an analysis of the health-care costs of the above services compared with usual care was conducted using decision modelling. Data were obtained from local services where possible, and the time horizon was 12 months. Results: (1) Quantitative component – characteristics of those discharged to primary care (n = 1410) were similar to those still in secondary care (n = 1629). Costs for those discharged to primary care were 48% lower than for those remaining in secondary care. Other variables strongly associated with costs were a history of violence and a diagnosis of schizophrenia or bipolar disorder. Few patients in secondary care had a high probability of primary care management and, therefore, excess costs were only around £150,000 across the sample. (2) Qualitative component – service users’ views about a community options team and a primary care support service were positive and compared favourably to services used previously. Views about peer support were slightly less consistent. Staff had concerns with regard to caseload sizes and staff turnover. (3) Economic modelling – services to help transition had costs that were 40% of those for standard care. The results of this showed that triaging patients into these services would save £1578 over a 1-year period and that the results were robust to changes in most parameters. Limitations: Analysis was hindered by the extent to which data were available. Qualitative analyses were limited by the fact that most of the participants did not have a SMI as usually defined and that many had been out of contact with secondary services for a long period of time. Conclusions: Costs are substantially lower in primary care than secondary care, even after controlling for service-user patient differences. Generally, there is satisfaction with services to help facilitate primary care provision and these appear to be cost saving. Future work should continue the analysis of linked data and involve a more comprehensive evaluation of the specific services investigated here. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background: Mental health professionals increasingly carry out risk assessments to prevent future violence by their patients. However, there are problems with accuracy and these assessments do not always translate into successful risk management. Objectives: Our aim was to improve the accuracy of assessment and identify risk factors that are causal to be targeted by clinicians to ensure good risk management. Our objectives were to investigate key risks at the population level, construct new static and dynamic instruments, test validity and construct new models of risk management using Bayesian networks. Methods and results: We utilised existing data sets from two national and commissioned a survey to identify risk factors at the population level. We confirmed that certain mental health factors previously thought to convey risk were important in future assessments and excluded others from subsequent parts of the study. Using a first-episode psychosis cohort, we constructed a risk assessment instrument for men and women and showed important sex differences in pathways to violence. We included a 1-year follow-up of patients discharged from medium secure services and validated a previously developed risk assessment guide, the Medium Security Recidivism Assessment Guide (MSRAG). We found that it is essential to combine ratings from static instruments such as the MSRAG with dynamic risk factors. Static levels of risk have important modifying effects on dynamic risk factors for their effects on violence and we further demonstrated this using a sample of released prisoners to construct risk assessment instruments for violence, robbery, drugs and acquisitive convictions. We constructed a preliminary instrument including dynamic risk measures and validated this in a second large data set of released prisoners. Finally, we incorporated findings from the follow-up of psychiatric patients discharged from medium secure services and two samples of released prisoners to construct Bayesian models to guide clinicians in risk management. Conclusions: Risk factors for violence identified at the population level, including paranoid delusions and anxiety disorder, should be integrated in risk assessments together with established high-risk psychiatric morbidity such as substance misuse and antisocial personality disorder. The incorporation of dynamic factors resulted in improved accuracy, especially when combined in assessments using actuarial measures to obtain levels of risk using static factors. It is important to continue developing dynamic risk and protective measures with the aim of identifying factors that are causally related to violence. Only causal factors should be targeted in violence prevention interventions. Bayesian networks show considerable promise in developing software for clinicians to identify targets for intervention in the field. The Bayesian models developed in this programme are at the prototypical stage and require further programmer development into applications for use on tablets. These should be further tested in the field and then compared with structured professional judgement in a randomised controlled trial in terms of their effectiveness in preventing future violence. Funding: The National Institute for Health Research Programme Grants for Applied Research programme.

Background: In 2010, South London and Maudsley NHS Foundation Trust (SLaM) established a programme replacing the borough directorates responsible for adult mental health services with three Clinical Academic Groups (CAGs), each of which took on a subset of adult services straddling all four boroughs. Care pathways were also introduced. We studied the Mood Anxiety and Personality CAG, which took on assessment and treatment teams and psychotherapy services. Objectives: We aimed (1) to understand the CAG programme using realistic evaluation and (2) to assess whether or not it led to changes in activity and health-care quality. Methods: Qualitative analysis was based on interviews and project documents. Quantitative analyses were based on electronic patient records and compared care in community mental health teams (CMHTs) and psychotherapy teams before and after CAG implementation. Analyses of activity covered caseload, counts of new episodes, episode length and number of contacts per episode. We also looked at CMHT costs. Analyses of effectiveness covered processes (pharmacological and psychological treatment of depression in CMHTs) and outcomes (effect on the Health of the Nation Outcome Scales total score or the Clinical Outcomes in Routine Evaluation 10-item version total score). Analyses of safety examined the rates of self-harm among current or recent CMHT patients. Patient centredness was represented by waiting time. Results: The first core component of SLaM’s CAG programme was the CAG restructuring itself. The second was the promotion of care pathways; interpreted as ‘high level pathways’, these schematised processes of referral, assessment, treatment, reassessment and discharge, but abstracted from the details of treatment. The three mechanisms of the CAG restructuring were increasing oversight, making teams fit the template of team types defined for each CAG (‘CAG compliance’) and changing financial accounts by grouping services in new ways; these mechanisms resulted in further reconfigurations. The use of high-level pathways supported service redesign and performance management. In CMHTs and psychotherapy teams activity tended to decrease, but this was probably not because of the CAG programme. CMHT costs were largely unchanged. There was no evidence that the CAG programme altered effectiveness or safety. Effects on waiting times varied but these were reduced in some cases. Overall, therefore, the CAG programme appeared to have had few effects on quality. We attributed this to the limited effect of the programme on individual treatment. Conclusions: SLaM’s CAG programme had clear effects on service reconfiguration at team level, with high-level pathways changing the ways that managers conceptualised their work. However, our quantitative work indicated no clear effects on quality. Thinking about how to use care pathways in ways that complement ‘high-level’ pathways by supporting the delivery of evidence-based treatments is a strategy that could help SLaM and other providers. Future research should look at the genesis of organisational change and how this is altered through implementation; it should also look at the effectiveness of care pathways in mental health services. Funding: The research was supported by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and was performed using infrastructure provided by the NIHR South London and Maudsley and Institute of Psychiatry Biomedical Research Centre.