Collaborative care approaches for people with severe mental illness.

BACKGROUND: Collaborative care for severe mental illness (SMI) is a community-based intervention that promotes interdisciplinary working across primary and secondary care. Collaborative care interventions aim to improve the physical and/or mental health care of individuals with SMI. This is an update of a 2013 Cochrane review, based on new searches of the literature, which includes an additional seven studies. OBJECTIVES: To assess the effectiveness of collaborative care approaches in comparison with standard care (or other non-collaborative care interventions) for people with diagnoses of SMI who are living in the community. SEARCH METHODS: We searched the Cochrane Schizophrenia Study-Based Register of Trials (10 February 2021). We searched the Cochrane Common Mental Disorders (CCMD) controlled trials register (all available years to 6 June 2016). Subsequent searches on Ovid MEDLINE, Embase and PsycINFO together with the Cochrane Central Register of Controlled Trials (with an overlap) were run on 17 December 2021. SELECTION CRITERIA: Randomised controlled trials (RCTs) where interventions described as 'collaborative care' were compared with 'standard care' for adults (18+ years) living in the community with a diagnosis of SMI. SMI was defined as schizophrenia, other types of schizophrenia-like psychosis or bipolar affective disorder. The primary outcomes of interest were: quality of life, mental state and psychiatric admissions at 12 months follow-up. DATA COLLECTION AND ANALYSIS: Pairs of authors independently extracted data. We assessed the quality and certainty of the evidence using RoB 2 (for the primary outcomes) and GRADE. We compared treatment effects between collaborative care and standard care. We divided outcomes into short-term (up to six months), medium-term (seven to 12 months) and long-term (over 12 months). For dichotomous data we calculated the risk ratio (RR) and for continuous data we calculated the standardised mean difference (SMD), with 95% confidence intervals (CIs). We used random-effects meta-analyses due to substantial levels of heterogeneity across trials. We created a summary of findings table using GRADEpro. MAIN RESULTS: Eight RCTs (1165 participants) are included in this review. Two met the criteria for type A collaborative care (intervention comprised of the four core components). The remaining six met the criteria for type B (described as collaborative care by the trialists, but not comprised of the four core components). The composition and purpose of the interventions varied across studies. For most outcomes there was low- or very low-certainty evidence. We found three studies that assessed the quality of life of participants at 12 months. Quality of life was measured using the SF-12 and the WHOQOL-BREF and the mean endpoint mental health component scores were reported at 12 months. Very low-certainty evidence did not show a difference in quality of life (mental health domain) between collaborative care and standard care in the medium term (at 12 months) (SMD 0.03, 95% CI -0.26 to 0.32; 3 RCTs, 227 participants). Very low-certainty evidence did not show a difference in quality of life (physical health domain) between collaborative care and standard care in the medium term (at 12 months) (SMD 0.08, 95% CI -0.18 to 0.33; 3 RCTs, 237 participants). Furthermore, in the medium term (at 12 months) low-certainty evidence did not show a difference between collaborative care and standard care in mental state (binary) (RR 0.99, 95% CI 0.77 to 1.28; 1 RCT, 253 participants) or in the risk of being admitted to a psychiatric hospital at 12 months (RR 5.15, 95% CI 0.67 to 39.57; 1 RCT, 253 participants). One study indicated an improvement in disability (proxy for social functioning) at 12 months in the collaborative care arm compared to usual care (RR 1.38, 95% CI 0.97 to 1.95; 1 RCT, 253 participants); we deemed this low-certainty evidence. Personal recovery and satisfaction/experience of care outcomes were not reported in any of the included studies. The data from one study indicated that the collaborative care treatment was more expensive than standard care (mean difference (MD) international dollars (Int$) 493.00, 95% CI 345.41 to 640.59) in the short term. Another study found the collaborative care intervention to be slightly less expensive at three years. AUTHORS' CONCLUSIONS: This review does not provide evidence to indicate that collaborative care is more effective than standard care in the medium term (at 12 months) in relation to our primary outcomes (quality of life, mental state and psychiatric admissions). The evidence would be improved by better reporting, higher-quality RCTs and the assessment of underlying mechanisms of collaborative care. We advise caution in utilising the information in this review to assess the effectiveness of collaborative care.

Transitional Care Interventions From Hospital to Community to Reduce Health Care Use and Improve Patient Outcomes: A Systematic Review and Network Meta-Analysis.

Importance: Discharge from the hospital to the community has been associated with serious patient risks and excess service costs. Objective: To evaluate the comparative effectiveness associated with transitional care interventions with different complexity levels at improving health care utilization and patient outcomes in the transition from the hospital to the community. Data Sources: CENTRAL, Embase, MEDLINE, and PsycINFO were searched from inception until August 2022. Study Selection: Randomized clinical trials evaluating transitional care interventions from hospitals to the community were identified. Data Extraction and Synthesis: At least 2 reviewers were involved in all data screening and extraction. Random-effects network meta-analyses and meta-regressions were applied. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Main Outcomes and Measures: The primary outcomes were readmission at 30, 90, and 180 days after discharge. Secondary outcomes included emergency department visits, mortality, quality of life, patient satisfaction, medication adherence, length of stay, primary care and outpatient visits, and intervention uptake. Results: Overall, 126 trials with 97 408 participants were included, 86 (68%) of which were of low risk of bias. Low-complexity interventions were associated with the most efficacy for reducing hospital readmissions at 30 days (odds ratio [OR], 0.78; 95% CI, 0.66 to 0.92) and 180 days (OR, 0.45; 95% CI, 0.30 to 0.66) and emergency department visits (OR, 0.68; 95% CI, 0.48 to 0.96). Medium-complexity interventions were associated with the most efficacy at reducing hospital readmissions at 90 days (OR, 0.64; 95% CI, 0.45 to 0.92), reducing adverse events (OR, 0.42; 95% CI, 0.24 to 0.75), and improving medication adherence (standardized mean difference [SMD], 0.49; 95% CI, 0.30 to 0.67) but were associated with less efficacy than low-complexity interventions for reducing readmissions at 30 and 180 days. High-complexity interventions were most effective for reducing length of hospital stay (SMD, -0.20; 95% CI, -0.38 to -0.03) and increasing patient satisfaction (SMD, 0.52; 95% CI, 0.22 to 0.82) but were least effective for reducing readmissions at all time periods. None of the interventions were associated with improved uptake, quality of life (general, mental, or physical), or primary care and outpatient visits. Conclusions and Relevance: These findings suggest that low- and medium-complexity transitional care interventions were associated with reducing health care utilization for patients transitioning from hospitals to the community. Comprehensive and consistent outcome measures are needed to capture the patient benefits of transitional care interventions.

Supporting carers to improve patient safety and maintain their well-being in transitions from mental health hospitals to the community: A prioritisation nominal group technique.

INTRODUCTION: Carers of people with mental illness may face distinct challenges, including navigating fragmented health and social services during discharge from mental health hospitals. Currently, limited examples of interventions that support carers of people with mental illness in improving patient safety during transitions of care exist. We aimed to identify problems and solutions to inform future carer-led discharge interventions, which is imperative for ensuring patient safety and the well-being of carers. METHODS: The nominal group technique was used which combines both qualitative and quantitative data collection methods in four distinct phases: (1) problem identification, (2) solution generation, (3) decision making and (4) prioritisation. The aim was to combine expertise from different stakeholder groups (patients, carers and academics with expertise in primary/secondary care, social care or public health) to identify problems and generate solutions. RESULTS: Twenty-eight participants generated potential solutions that were grouped into four themes. The most acceptable solution for each was as follows: (1) 'Carer Involvement and Improving Carer Experience' a dedicated family liaison worker, (2) 'Patient Wellness and Education' adapting and implementing existing approaches to help implement the patient care plan, (3) 'Carer Wellness and Education' peer/social support interventions for carers and (4) 'Policy and System Improvements' understanding the co-ordination of care. CONCLUSION: The stakeholder group concurred that the transition from mental health hospitals to the community is a distressing period, where patients and carers are particularly vulnerable to safety and well-being risks. We identified numerous feasible/acceptable solutions to enable carers to improve patient safety and maintain their own mental wellbeing. PATIENT AND PUBLIC CONTRIBUTION: Patient and public contributors were represented in the workshop and the focus of the workshop was to identify the problems they faced and co-design potential solutions. Patient and public contributors were involved in the funding application and study design.

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study.

INTRODUCTION: Patients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care. METHODS AND ANALYSIS: Two uncontrolled before-and-after feasibility studies, where all participants will receive the intervention. We will examine the feasibility and acceptability of the SAFER-MH in inpatient mental health settings in patients aged 18 years or older who are being discharged and the feasibility and acceptability of the SAFER-YMH intervention in inpatient mental health settings in patients aged between 14 and 18 years who are being discharged. The baseline period and intervention periods are both 6 weeks. SAFER-MH will be implemented in three wards and SAFER-YMH in one or two wards, ideally across different trusts within England. We will use quantitative (eg, questionnaires, completion forms) and qualitative (eg, interviews, process evaluation) methods to assess the acceptability and feasibility of the two versions of the intervention. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients/wards should be included. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Health Service Cornwall and Plymouth Research Ethics Committee and Surrey Research Ethics Committee (reference: 22/SW/0096 and 22/LO/0404). Research findings will be disseminated with participating sites and shared in various ways to engage different audiences. We will present findings at international and national conferences, and publish in open-access, peer-reviewed journals.

Developing the Resident Measure of Safety in Care Homes (RMOS): A Delphi and Think Aloud Study.

OBJECTIVE: This study aimed to develop a measure of contributory factors to safety incidents in care homes to be completed by residents and/or their unpaid carers. INTRODUCTION: Care home residents are particularly vulnerable to patient safety incidents, due to higher likelihood of frailty, multimorbidity and cognitive decline. However, despite residents and their carers wanting to be involved in safety initiatives, there are few mechanisms for them to contribute and make meaningful safety improvements to practice. METHODS: We developed 73 evidence-based items from synthesis and existing measures, which we presented to a panel of stakeholders (residents/carers, health/social care professionals and researchers). We used two online rounds of Delphi to generate consensus (80%) on items important to include in the Resident Measure of Safety in Care Homes (RMOS); a consensus meeting was later held. The draft RMOS developed through the Delphi was presented to participants during 'Think Aloud' interviews using cognitive testing techniques. RESULTS: The 29-item RMOS was developed. Forty-three participants completed Delphi round 1, and 27 participants completed round 2, 11 participants attended the consensus meeting and 12 'Think Aloud' interviews were conducted. Of the 73 original items, 42 items that did not meet consensus in Delphi round 1 were presented in round 2. After the consensus meeting, it was agreed that 35 items would comprise the RMOS questionnaire and were presented in the 'Think Aloud' interviews. Participants suggested numerous changes to items mostly to improve comprehension and ability to answer. CONCLUSION: We have a developed an evidence-based RMOS, with good face validity, to assess contributory factors to safety in care homes from a resident/carer perspective. Future work will involve psychometrically testing the items in a pilot and developing a complementary simplified, dementia-friendly version to promote inclusivity. PATIENT OR PUBLIC INVOLVEMENT: Four patient and public contributors worked with researchers to develop the online questionnaires. Patients (residents) and carers participated on the consensus panel. One member of the research team is an expert by lived experience and was involved in design and analysis decisions. The item list and instructions for the questionnaires were reviewed for face validity, understanding and acceptability by a patient and public involvement group and modified.

Transitional Care Interventions for Older Residents of Long-term Care Facilities: A Systematic Review and Meta-analysis.

Importance: Residents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents. Objective: To assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association. Data Sources: MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology. Study Selection: Controlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria. Data Extraction and Synthesis: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest. Main Outcomes and Measures: The primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity. Results: Of 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals. Conclusions and Relevance: Emerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

Developing Best Practice Guidance for Discharge Planning Using the RAND/UCLA Appropriateness Method.

Background: Discharge from acute mental health inpatient units is often a vulnerable period for patients. Multiple professionals and agencies are involved and processes and procedures are not standardized, often resulting in communication delays and co-ordination failures. Early and appropriate discharge planning and standardization of procedures could make inpatient care safer. Aim: To inform the development of a multi-component best practice guidance for discharge planning (including the 6 component SAFER patient flow bundle) to support safer patient transition from mental health hospitals to the community. Methods: Using the RAND/UCLA Appropriateness method, a panel of 10 professional stakeholders (psychiatrists, psychiatric nurses, clinical psychologists, pharmacists, academics, and policy makers) rated evidence-based statements. Six hundred and sixty-eight statements corresponding to 10 potential components of discharge planning best practice were rated on a 9-point integer scale for clarity, appropriateness and feasibility (median ≥ 7-9) using an online questionnaire then remote online face-to-face meetings. Results: Five of the six "SAFER" patient flow bundle components were appropriate and feasible for inpatient mental health. One component, "Early Flow," was rated inappropriate as mental health settings require more flexibility. Overall, 285 statements were rated as appropriate and feasible. Forty-four statements were considered appropriate but not feasible to implement. Discussion: This consensus study has identified components of a best practice guidance/intervention for discharge planning for UK mental health settings. Although some components describe processes that already happen in everyday clinical interactions (i.e., review by a senior clinician), standardizing such processes could have important safety benefits alongside a tailored and timely approach to post-discharge care.

Consultation patterns and frequent attenders in UK primary care from 2000 to 2019: a retrospective cohort analysis of consultation events across 845 general practices.

OBJECTIVE: To describe the distribution of consultations at the practice level and examine whether increases are uniform or driven by people who consult more frequently. DESIGN: Retrospective cohort study. SETTING: UK general practice data from the Clinical Practice Research Datalink (CPRD) GOLD database. PARTICIPANTS: 1 699 709 314 consultation events from 12 330 545 patients, in 845 general practices (1 April 2000 to 31 March 2019). METHODS: Consultation information was aggregated by financial year into: all consultations/all staff; all consultations/general practitioners (GPs); face-to-face consultations/all staff; face-to-face consultations/GPs. Patients with a number of consultations above the 90th centile, within each year, were classified as frequent attenders. Negative binomial regressions examined the association between available practice characteristics and consultation distribution. RESULTS: Among frequent attenders, all consultations by GPs increased from a median (25th and 75th centile) of 13 (10 and 16) to 21 (18 and 25) and all consultations by all staff increased from 27 (23-30) to 60 (51-69) over the study period. Approximately four out of ten consultations of any type concerned frequent attenders and the proportion of consultations attributed to them increased over time, particularly for face-to-face consultations with GPs, from a median of 38.0% (35.9%-40.3%) in 2000-2001 to 43.0% (40.6%-46.4%) in 2018-2019. Regression analyses indicated decreasing trends over time for face-to-face consultations and increasing trends for all consultation types, for both GPs and all staff. Frequent attenders consulted approximately five times more than the rest of the practice population, on average, with adjusted incidence rate ratios ranging between 4.992 (95% CI 4.917 to 5.068) for face-to-face consultations with all staff and 5.603 (95% CI 5.560 to 5.647) for all consultations with GPs. CONCLUSIONS: Frequent attenders progressively contributed to increased workload in general practices across the UK from 2000 to 2019. Important knowledge gaps remain in terms of the demographic, social and health characteristics of frequent attenders and how UK general practices can be prepared to meet the needs of these patients.

Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial.

BACKGROUND: Current NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The 'PARTNERS2' complex intervention is designed to support individuals with psychosis in a primary care setting. AIM: The trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention. DESIGN & SETTING: This is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with usual care, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth, and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care ('intervention'); or (b) standard care only ('control'). METHOD: PARTNERS2 is a flexible, general practice-based, person-centred, coaching-based intervention aimed at addressing mental health, physical health, and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life (QOL). Secondary outcomes include: mental wellbeing, time use, recovery, and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action, and look for unintended consequences. An economic evaluation will estimate its cost-effectiveness. Intervention delivery and follow-up have been modified during the COVID-19 pandemic. CONCLUSION: The overarching aim is to establish the clinical and cost-effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychoses.

Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials.

BACKGROUND: Participant recruitment and retention are long-standing problems in clinical trials. Although there are a large number of factors impacting on recruitment and retention, some of the problems may reflect the fact that trial design and delivery is not sufficiently 'patient-centred' (i.e., sensitive to patient needs and preferences). Most trials collect process and outcome measures, but it is unclear whether patient experience of trial participation itself is routinely measured. We conducted a structured scoping review of studies reporting standardised assessment of patient experience of participation in a trial. METHODS: A structured search of Medline, PsycINFO, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) and hand searching of included studies were conducted in 2016. Additional sources included policy documents, relevant websites and experts. We extracted data on trial context (type, date and location) and measure type (number of items and mode of administration), patient experience domains measured, and the results reported. We conducted a narrative synthesis. RESULTS: We identified 22 journal articles reporting on 21 different structured measures of participant experience in trials. None of the studies used a formal definition of patient experience. Overall, patients reported relatively high levels of global satisfaction with the trial process as well as positive outcomes (such as the likelihood of future participation or recommendation of the trial to others). CONCLUSIONS: Current published evidence is sparse. Standardised assessment of patient experience of trial participation may provide opportunities for researchers to enhance trial design and delivery. This could complement other methods of enhancing the patient-centredness of trials and might improve recruitment, retention, and long-term patient engagement with trials.

Using electronic health records to quantify and stratify the severity of type 2 diabetes in primary care in England: rationale and cohort study design.

INTRODUCTION: The increasing prevalence of type 2 diabetes mellitus (T2DM) presents a significant burden on affected individuals and healthcare systems internationally. There is, however, no agreed validated measure to infer diabetes severity from electronic health records (EHRs). We aim to quantify T2DM severity and validate it using clinical adverse outcomes. METHODS AND ANALYSIS: Primary care data from the Clinical Practice Research Datalink, linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in England will be used to develop a clinical algorithm to grade T2DM severity. The EHR-based algorithm will incorporate main risk factors (severity domains) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores. Provisionally, T2DM severity domains, identified through a systematic review and expert opinion, are: diabetes duration, glycated haemoglobin, microvascular complications, comorbidities and coprescribed treatments. Severity scores will be developed by two approaches: (1) calculating a count score of severity domains; (2) through hierarchical stratification of complications. Regression models estimates will be used to calculate domains weights. Survival analyses for the association between weighted severity scores and future outcomes-cardiovascular events, hospitalisation (diabetes-related, cardiovascular) and mortality (diabetes-related, cardiovascular, all-cause mortality)-will be performed as statistical validation. The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions. We anticipate that the developed algorithm will be a practical tool for practitioners, aid clinical management decision-making, inform stratified medicine, support future clinical trials and contribute to more effective service planning and policy-making. ETHICS AND DISSEMINATION: The study protocol was approved by the Independent Scientific Advisory Committee. Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase, September 2017, Oxford, UK and the Diabetes UK Professional Conference March 2018, London, UK. The study findings will be disseminated in relevant academic conferences and peer-reviewed journals.

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

BACKGROUND: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. OBJECTIVE: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. DESIGN: A modified Delphi process including a two round online survey and a stakeholder consensus meeting. PARTICIPANTS: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. RESULTS: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. CONCLUSIONS: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Making the journey with me: a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness.

BACKGROUND: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial. METHODS: Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method. RESULTS: Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users' illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems. CONCLUSION: The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236 . Registered 3(rd) July 2009.

Modelling Conditions and Health Care Processes in Electronic Health Records: An Application to Severe Mental Illness with the Clinical Practice Research Datalink.

BACKGROUND: The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. METHODS: We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. RESULTS: We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. CONCLUSION: We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists.

Inequalities in physical comorbidity: a longitudinal comparative cohort study of people with severe mental illness in the UK.

OBJECTIVES: Little is known about the prevalence of comorbidity rates in people with severe mental illness (SMI) in UK primary care. We calculated the prevalence of SMI by UK country, English region and deprivation quintile, antipsychotic and antidepressant medication prescription rates for people with SMI, and prevalence rates of common comorbidities in people with SMI compared with people without SMI. DESIGN: Retrospective cohort study from 2000 to 2012. SETTING: 627 general practices contributing to the Clinical Practice Research Datalink, a UK primary care database. PARTICIPANTS: Each identified case (346,551) was matched for age, sex and general practice with 5 randomly selected control cases (1,732,755) with no diagnosis of SMI in each yearly time point. OUTCOME MEASURES: Prevalence rates were calculated for 16 conditions. RESULTS: SMI rates were highest in Scotland and in more deprived areas. Rates increased in England, Wales and Northern Ireland over time, with the largest increase in Northern Ireland (0.48% in 2000/2001 to 0.69% in 2011/2012). Annual prevalence rates of all conditions were higher in people with SMI compared with those without SMI. The discrepancy between the prevalence of those with and without SMI increased over time for most conditions. A greater increase in the mean number of additional conditions was observed in the SMI population over the study period (0.6 in 2000/2001 to 1.0 in 2011/2012) compared with those without SMI (0.5 in 2000/2001 to 0.6 in 2011/2012). For both groups, most conditions were more prevalent in more deprived areas, whereas for the SMI group conditions such as hypothyroidism, chronic kidney disease and cancer were more prevalent in more affluent areas. CONCLUSIONS: Our findings highlight the health inequalities faced by people with SMI. The provision of appropriate timely health prevention, promotion and monitoring activities to reduce these health inequalities are needed, especially in deprived areas.

Primary care consultation rates among people with and without severe mental illness: a UK cohort study using the Clinical Practice Research Datalink.

OBJECTIVES: Little is known about service utilisation by patients with severe mental illness (SMI) in UK primary care. We examined their consultation rate patterns and whether they were impacted by the introduction of the Quality and Outcomes Framework (QOF), in 2004. DESIGN: Retrospective cohort study using individual patient data collected from 2000 to 2012. SETTING: 627 general practices contributing to the Clinical Practice Research Datalink, a large UK primary care database. PARTICIPANTS: SMI cases (346,551) matched to 5 individuals without SMI (1,732,755) on age, gender and general practice. OUTCOME MEASURES: Consultation rates were calculated for both groups, across 3 types: face-to-face (primary outcome), telephone and other (not only consultations but including administrative tasks). Poisson regression analyses were used to identify predictors of consultation rates and calculate adjusted consultation rates. Interrupted time-series analysis was used to quantify the effect of the QOF. RESULTS: Over the study period, face-to-face consultations in primary care remained relatively stable in the matched control group (between 4.5 and 4.9 per annum) but increased for people with SMI (8.8-10.9). Women and older patients consulted more frequently in the SMI and the matched control groups, across all 3 consultation types. Following the introduction of the QOF, there was an increase in the annual trend of face-to-face consultation for people with SMI (average increase of 0.19 consultations per patient per year, 95% CI 0.02 to 0.36), which was not observed for the control group (estimates across groups statistically different, p=0.022). CONCLUSIONS: The introduction of the QOF was associated with increases in the frequency of monitoring and in the average number of reported comorbidities for patients with SMI. This suggests that the QOF scheme successfully incentivised practices to improve their monitoring of the mental and physical health of this group of patients.

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

BACKGROUND: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial. METHODS: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236. FINDINGS: Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8-10·5). INTERPRETATION: We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial. FUNDING: National Institute of Health Research Health Technology Assessment Programme.

Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial of the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation service.

BACKGROUND: There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI. OBJECTIVE: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI. DESIGN: A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation. SETTING: Primary care and secondary care mental health services in England. PARTICIPANTS: Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking. INTERVENTIONS: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care. MAIN OUTCOME MEASURES: The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation. RESULTS: The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis. CONCLUSIONS: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

Serious mental illness and the role of primary care.

Policies and guidelines from across the international community are attempting to galvanise action to address the unacceptably high morbidity and mortality rates amongst people with a serious mental illness (SMI). Primary care has a pivotal role to play in translating policy into evidence based practice in conjunction with other providers of health care services. This paper explores the current and potential of role of primary care providers in delivering health care to people with SMI. A review of research in the following key areas of primary health care provision is provided: access, screening and preventative care, routine monitoring and follow-up, diagnosis and delivery of treatments in accordance with guidelines and delivery of interventions. There is undoubtedly a need for further research to establish the effectiveness of primary care interventions and the organisation of services. Equally, understanding how primary care services can deliver high quality care and promoting effective working at the interface with other services must be priorities.

Collaborative care approaches for people with severe mental illness.

BACKGROUND: Collaborative care for severe mental illness (SMI) is a community-based intervention, which typically consists of a number of components. The intervention aims to improve the physical and/or mental health care of individuals with SMI. OBJECTIVES: To assess the effectiveness of collaborative care approaches in comparison with standard care for people with SMI who are living in the community. The primary outcome of interest was psychiatric admissions. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Specialised register in April 2011. The register is compiled from systematic searches of major databases, handsearches of relevant journals and conference proceedings. We also contacted 51 experts in the field of SMI and collaborative care. SELECTION CRITERIA: Randomised controlled trials (RCTs) described as collaborative care by the trialists comparing any form of collaborative care with 'standard care' for adults (18+ years) living in the community with a diagnosis of SMI, defined as schizophrenia or other types of schizophrenia-like psychosis (e.g. schizophreniform and schizoaffective disorders), bipolar affective disorder or other types of psychosis. DATA COLLECTION AND ANALYSIS: Two review authors worked independently to extract and quality assess data. For dichotomous data, we calculated the risk ratio (RR) with 95% confidence intervals (CIs) and we calculated mean differences (MD) with 95% CIs for continuous data. Risk of bias was assessed. MAIN RESULTS: We included one RCT (306 participants; US veterans with bipolar disorder I or II) in this review. We did not find any trials meeting our inclusion criteria that included people with schizophrenia. The trial provided data for one comparison: collaborative care versus standard care. All results are 'low or very low quality evidence'.Data indicated that collaborative care reduced psychiatric admissions at year two in comparison to standard care (n = 306, 1 RCT, RR 0.75, 95% CI 0.57 to 0.99).The sensitivity analysis showed that the proportion of participants psychiatrically hospitalised was lower in the intervention group than the standard care group in year three: 28% compared to 38% (n = 330, 1 RCT, RR 0.72, 95% CI 0.53 to 0.99).In comparison to the standard care group, collaborative care significantly improved the Mental Health Component (MHC) of quality of life at the three-year follow-up, (n = 306, 1 RCT, MD 3.50, 95% CI 1.80 to 5.20). The Physical Health Component (PHC) of the quality of life measure at the three-year follow-up did not differ significantly between groups (n = 306, 1 RCT, MD 0.50, 95% CI 0.91 to 1.91).Direct intervention (all-treatment) costs of collaborative care at the three-year follow-up did not differ significantly from standard care (n = 306, 1 RCT, MD -$2981.00, 95% CI $16934.93 to $10972.93). The proportion of participants leaving the study early did not differ significantly between groups (n = 306, 1 RCT, RR 1.71, 95% CI 0.77 to 3.79). There is no trial-based information regarding the effect of collaborative care for people with schizophrenia.No statistically significant differences were found between groups for number of deaths by suicide at three years (n = 330, 1 RCT, RR 0.34, 95% CI 0.01 to 8.32), or the number of participants that died from all other causes at three years (n = 330, 1 RCT, RR 1.54, 95% CI 0.65 to 3.66). AUTHORS' CONCLUSIONS: The review did not identify any studies relevant to care of people with schizophrenia and hence there is no evidence available to determine if collaborative care is effective for people suffering from schizophrenia or schizophreniform disorders. There was however one trial at high risk of bias that suggests that collaborative care for US veterans with bipolar disorder may reduce psychiatric admissions at two years and improves quality of life (mental health component) at three years, however, on its own it is not sufficient for us to make any recommendations regarding its effectiveness. More large, well designed, conducted and reported trials are required before any clinical or policy making decisions can be made.