Integrated Care to Address the Physical Health Needs of People with Severe Mental Illness : A Mapping Review of the Recent Evidence on Barriers, Facilitators and Evaluations

People with mental health conditions have a lower life expectancy and poorer physical health outcomes than the general population. Evidence suggests this is due to a combination of clinical risk factors, socioeconomic factors, and health system factors, notably a lack of integration when care is required across service settings. Several recent reports have looked at ways to better integrate physical and mental health care for people with severe mental illness (SMI). We built on these by conducting a mapping review that looked for the most recent evidence and service models in this area. This involved searching the published literature and speaking to people involved in providing or using current services. Few of the identified service models were described adequately and fewer still were evaluated, raising questions about the replicability and generalisability of much of the existing evidence. However, some common themes did emerge. Efforts to improve the physical health care of people with SMI should empower staff and service users and help remove everyday barriers to delivering and accessing integrated care. In particular, there is a need for improved communication among professionals and better information technology to support them, greater clarity about who is responsible and accountable for physical health care, and greater awareness of the effects of stigmatisation on the wider culture and environment in which services are delivered

An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

BACKGROUND: In comparison with other study designs, randomised trials are regarded as particularly likely to benefit from patient and public involvement (PPI). Using mixed-methods research we investigated PPI from the perspectives of researchers and PPI contributors. METHODS: Randomised trials in receipt of funding from the Health Technology Assessment (HTA) programme between 2006 and 2010 were identified. Funding applications and board and referee comments were obtained and data relevant to PPI extracted. Chief investigators (CIs), PPI contributors and UK Clinical Research Collaboration Registered Clinical Trials Units (RCTUs) were surveyed. Interviews were conducted with researchers and PPI contributors. RESULTS: A total of 111 trials were included. Text relevant to PPI was identified in half of the trials for which the first-stage applications were available, but only one-quarter described PPI within their development. In the second stage of the application, the majority provided some text relevant to PPI, with over half having PPI in their development. Fewer than half of referees commented on PPI, and funding boards rarely provided comments in relation to PPI. Seventy-three per cent (81 of 111) of CIs responded to the survey and 98% (79 of 81) included PPI at some stage in their trial. CIs considered high impact from PPI contributors to occur more frequently in trial setup, with low or no impact being more common during trial conduct, analysis and dissemination. Only one-third of CIs provided PPI contributor contact details but all contributors contacted completed the survey. The majority of contributors felt engaged and valued by the research team. Interviews were conducted with researchers and/or PPI contributors for 28 trials identifying two main influences on perception of PPI impact: whether or not CIs expressed personal goals and plans for PPI; and the quality of their relationship with the PPI contributors. The importance of early engagement was identified, with opportunity for input thereafter limited. Three PPI roles were identified: oversight, managerial and responsive. Oversight roles, as required by funders, were associated with low impact in comparison with responsive or managerial roles. Most researchers could see some value in PPI training for researchers, although those that had received such training themselves expressed concerns about its purpose and evidence base. Training for PPI contributors was considered unnecessary, with conversational approaches preferred, although this did not appear to provide an opportunity for role negotiation. The RCTU survey response rate was 85% (39 of 46). The majority (37 of 39) reported PPI within trials co-ordinated by their unit. Trial characteristics were used by half to determine the approach to PPI. Two-thirds reported recent developments or changes in implementing plans for PPI (21 of 33). Support to PPI contributors was commonly offered through members of staff at the unit. CONCLUSIONS: PPI is occurring in the majority of trials funded by the HTA programme, but uncertainty remains about how it is assessed and valued. Early involvement, building a relationship between researchers and contributors, responsive or managerial roles, and having defined goals for PPI were associated with impact. Efficiency could be gained by utilising the RCTU network to identify and tackle challenges, and develop a risk-based approach utilising trial characteristics. Recommendations are made to trial funders and the research community. Given the difficulties for some informants in recalling PPI contributions, future research using a prospective approach would be valuable. Ethnographic research that combines observation and multi-informant interviews is likely to be informative in identifying impact. The research community needs to give further consideration to processes for selecting PPI contributors and models of implementing PPI

Integrated care to address the physical health needs of people with severe mental illness : a rapid review

Background People with mental health conditions have a lower life expectancy and poorer physical health outcomes than the general population. Evidence suggests that this discrepancy is driven by a combination of clinical risk factors, socioeconomic factors and health system factors. Objective(s) To explore current service provision and map the recent evidence on models of integrated care addressing the physical health needs of people with severe mental illness (SMI) primarily within the mental health service setting. The research was designed as a rapid review of published evidence from 2013–15, including an update of a comprehensive 2013 review, together with further grey literature and insights from an expert advisory group. Synthesis We conducted a narrative synthesis, using a guiding framework based on nine previously identified factors considered to be facilitators of good integrated care for people with mental health problems, supplemented by additional issues emerging from the evidence. Descriptive data were used to identify existing models, perceived facilitators and barriers to their implementation, and any areas for further research. Findings and discussion The synthesis incorporated 45 publications describing 36 separate approaches to integrated care, along with further information from the advisory group. Most service models were multicomponent programmes incorporating two or more of the nine factors: (1) information sharing systems; (2) shared protocols; (3) joint funding/commissioning; (4) colocated services; (5) multidisciplinary teams; (6) liaison services; (7) navigators; (8) research; and (9) reduction of stigma. Few of the identified examples were described in detail and fewer still were evaluated, raising questions about the replicability and generalisability of much of the existing evidence. However, some common themes did emerge from the evidence. Efforts to improve the physical health care of people with SMI should empower people (staff and service users) and help remove everyday barriers to delivering and accessing integrated care. In particular, there is a need for improved communication between professionals and better information technology to support them, greater clarity about who is responsible and accountable for physical health care, and awareness of the effects of stigmatisation on the wider culture and environment in which services are delivered. Limitations and future work The literature identified in the rapid review was limited in volume and often lacked the depth of description necessary to acquire new insights. All members of our advisory group were based in England, so this report has limited information on the NHS contexts specific to Scotland, Wales and Northern Ireland. A conventional systematic review of this topic would not appear to be appropriate in the immediate future, although a more interpretivist approach to exploring this literature might be feasible. Wherever possible, future evaluations should involve service users and be clear about which outcomes, facilitators and barriers are likely to be context-specific and which might be generalisable

Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review

Background - Acupuncture within pregnancy has frequently been investigated, often with finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear. Objective - To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups. Results - Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3%-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14%-17% in the acupuncture groups and 15-19% in non-acupuncture groups. Conclusions - Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture related interventions

Who needs what from a national health research system: Lessons from reforms to the English Department of Health's R&D system

This article has been made available through the Brunel Open Access Publishing Fund.Health research systems consist of diverse groups who have some role in health research, but the boundaries around such a system are not clear-cut. To explore what various stakeholders need we reviewed the literature including that on the history of English health R&D reforms, and we also applied some relevant conceptual frameworks. We first describe the needs and capabilities of the main groups of stakeholders in health research systems, and explain key features of policymaking systems within which these stakeholders operate in the UK. The five groups are policymakers (and health care managers), health professionals, patients and the general public, industry, and researchers. As individuals and as organisations they have a range of needs from the health research system, but should also develop specific capabilities in order to contribute effectively to the system and benefit from it. Second, we discuss key phases of reform in the development of the English health research system over four decades - especially that of the English Department of Health's R&D system - and identify how far legitimate demands of key stakeholder interests were addressed. Third, in drawing lessons we highlight points emerging from contemporary reports, but also attempt to identify issues through application of relevant conceptual frameworks. The main lessons are: the importance of comprehensively addressing the diverse needs of various interacting institutions and stakeholders; the desirability of developing facilitating mechanisms at interfaces between the health research system and its various stakeholders; and the importance of additional money in being able to expand the scope of the health research system whilst maintaining support for basic science. We conclude that the latest health R&D strategy in England builds on recent progress and tackles acknowledged weaknesses. The strategy goes a considerable way to identifying and more effectively meeting the needs of key groups such as medical academics, patients and industry, and has been remarkably successful in increasing the funding for health research. There are still areas that might benefit from further recognition and resourcing, but the lessons identified, and progress made by the reforms are relevant for the design and coordination of national health research systems beyond England.This article is available through the Brunel Open Access Publishing Fund

Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation

Background: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA®, AbbVie, Maidenhead, UK), etanercept (Enbrel®, Pfizer, New York, NY, USA) and ustekinumab (STELARA®, Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. Objective: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people. Data sources: Searches of the literature and regulatory sources, contact with European psoriasis registries, company submissions and clinical study reports from manufacturers, and previous National Institute for Health and Care Excellence (NICE) technology appraisal documentation. Review methods: Included studies were summarised and subjected to detailed critical appraisal. A network meta-analysis incorporating adult data was developed to connect the effectiveness data in children and young people and populate a de novo decision-analytic model. The model estimated the cost-effectiveness of adalimumab, etanercept and ustekinumab compared with each other and with either methotrexate or best supportive care (BSC), depending on the position of the intervention in the management pathway. Results: Of the 2386 non-duplicate records identified, nine studies (one randomised controlled trial for each drug plus six observational studies) were included in the review of clinical effectiveness and safety. Etanercept and ustekinumab resulted in significantly greater improvements in psoriasis symptoms than placebo at 12 weeks’ follow-up. The magnitude and persistence of the effects beyond 12 weeks is less certain. Adalimumab resulted in significantly greater improvements in psoriasis symptoms than methotrexate for some but not all measures at 16 weeks. Quality-of-life benefits were inconsistent across different measures. There was limited evidence of excess short-term adverse events; however, the possibility of rare events cannot be excluded. The majority of the incremental cost-effectiveness ratios for the use of biologics in children and young people exceeded NICE’s usual threshold for cost-effectiveness and were reduced significantly only when combined assumptions that align with those made in the management of psoriasis in adults were adopted. Limitations: The clinical evidence base for short- and long-term outcomes was limited in terms of total participant numbers, length of follow-up and the absence of young children. Conclusions: The paucity of clinical and economic evidence to inform the cost-effectiveness of biological treatments in children and young people imposed a number of strong assumptions and uncertainties. Health-related quality-of-life (HRQoL) gains associated with treatment and the number of hospitalisations in children and young people are areas of considerable uncertainty. The findings suggest that biological treatments may not be cost-effective for the management of psoriasis in children and young people at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year, unless a number of strong assumptions about HRQoL and the costs of BSC are combined. Registry data on biological treatments would help determine safety, patterns of treatment switching, impact on comorbidities and long-term withdrawal rates. Further research is also needed into the resource use and costs associated with BSC. Adequately powered randomised controlled trials (including comparisons against placebo) could substantially reduce the uncertainty surrounding the effectiveness of biological treatments in biologic-experienced populations of children and young people, particularly in younger children. Such trials should establish the impact of biological therapies on HRQoL in this population, ideally by collecting direct estimates of EuroQol-5 Dimensions for Youth (EQ-5D-Y) utilities. Study registration: This study is registered as PROSPERO CRD42016039494. Funding: The National Institute for Health Research Health Technology Assessment programme

Can Healthcare Assistant Training (CHAT) improve the relational care of older people? A developmental and feasibility study of a complex intervention

Background: Older people account for an increasing proportion of those receiving NHS acute care. The quality of healthcare delivered to older people has come under increased scrutiny. Healthcare assistants (HCAs) provide much of the direct care of older people in hospital. Patients’ experience of care tends to be based on the relational aspects of that care including dignity, empathy and emotional support. Objective(s): We aimed to: understand the relational care training needs of HCAs caring for older people; design a relational care training intervention for HCAs; and assess the feasibility of a cluster-randomised controlled trial to test the new intervention against HCA training as usual. Design: (1) Telephone survey of all NHS hospital Trusts in England to assess current HCA training provision; (2) focus groups of older people and carers and (3) semi-structured interviews with HCAs and other care staff to establish training needs and inform intervention development; (4) feasibility cluster-randomised controlled trial. Setting: (1) All acute NHS hospital Trusts in England; (2,3,4) Three acute NHS hospital Trusts in England and the populations they serve. Participants: (1) 113 of 161 (70.2%) Trusts took part in the telephone survey; (2) 29 older people or carer participants of three focus groups; (3) 30 HCA and 24 ‘other staff’ interviewees; (4) 12 wards (four per Trust); 112 HCAs; 92 patients during the pre-randomisation period and 67 patients during the post-randomisation period. Interventions: For the feasibility trial a training intervention (Older People’s Shoes) for HCAs developed as part of the study was compared with HCA training as usual. Main outcome measures: Patient level outcomes were the experience of emotional care and quality of life during their hospital stay as measured by the Patient Evaluation of Emotional Care during Hospitalisation (PEECH) and the European Quality of Life (EQ-5D) questionnaires. HCA outcomes were empathy measured by the Toronto Empathy Questionnaire (TEQ) and attitudes towards older people measured by the Age Group Evaluation and Description (AGED) Inventory. Ward level outcomes were the quality of HCA/patient interaction measured by the Quality of Interaction Scale (QUIS). Results: (1) A third of Trust telephone survey participants reported HCA training content that we considered to be ‘relational care’. Training for HCAs is variable across Trusts and focused on new recruits. The biggest challenge for HCA training is getting HCAs released from ward duties. (2) Older people and carers are aware of the pressures ward staff are under but good relationships with care staff determines whether the experience of hospital is positive. (3) HCAs have training needs related to ‘difficult conversations’ with patients and relatives; they have particular preferences for learning styles that are not always reflected in available training. (4) In the feasibility trial 187 of the 192 planned ward observation sessions were completed; response to HCA questionnaires at baseline, eight and 12 weeks post-randomisation was 64.2%, 46.4% and 35.7% respectively; 57.2% of eligible patients returned completed questionnaires. Limitations: This was an intervention development and feasibility study so no conclusions can be drawn about the effectiveness of the intervention. Conclusions: The intervention had high acceptability among nurse trainers and HCA learners. Viability of a definitive trial is conditional on overcoming specific methodological (patient recruitment processes) and contextual (involvement of wider ward team) challenges. Future work: Methods to ease the burden of questionnaire completion without compromising ethics or methodological rigour need to be explored. Study registration: ISRCTN1038579

Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

Background: Depression and debt are common in the UK. The DeCoDer trial aimed to assess the clinical and cost effectiveness of the addition of Primary Care debt counselling advice service to usual care, for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. Specific objectives were to: confirm methods for practice recruitment, ability to recruit patients via the proposed approaches, determine acceptability of the study interventions and outcome measures; assess contamination, confirm the randomisation method for main trial, the level of participant attrition; and check robustness of data collection systems. Design: Adaptive parallel two group multi-centre randomised controlled pilot trial with nested mixed methods process and economic evaluation. Both individual and cluster (General Practice) level allocation were used in the pilot phase to assign participants to intervention or control groups. Setting: General practices in England and Wales.Participants: Individuals age ≥18 years, scoring ≥14 on the Beck Depression Inventory and self-identifying as having debt worries were included. Main exclusion criteria were: actively suicidal or psychotic and/or severely depressed and unresponsive to treatment, severe addiction to alcohol/illicit drugs, unable/unwilling to give written informed consent, currently participating in other research including follow-up phases, received Citizen’s Advice Bureau (CAB) debt advice in past year, and not wanting debt advice via GP practice. Interventions: Intervention: debt advice provided by CAB and shared biopsychosocial assessment in addition to treatment as usual (TAU) and two debt advice leaflets; Control: advice leaflets provided by GP and TAU only. Outcomes of pilot trial: Proportion of eligible patients who consented; number of participants recruited compared to target; assessment of contamination; assessment of patient satisfaction with intervention and outcome measures.Participant outcomes: Primary: Beck Depression Inventory II; Secondary: Psychological wellbeing, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and 4-months post randomisation. Other data sources: Qualitative interviews were conducted with participants, clinicians and CAB advisors.Results: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 intervention and 29 control). All participants provided baseline outcomes and 52 provided primary outcome at four months follow up (14.7% drop out). 17 participants allocated to intervention saw CAB. Descriptive statistics are reported for participants with complete outcomes at baseline and 4-months’ follow up. Our qualitative findings suggest that the relationship between debt and depression is complex and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions, Study Limitations and Future work: Due to low recruitment this trial was terminated at the internal pilot phase, and too small for inferential statistical analysis. We provide implications for conducting future research in this area