There is another way: empowering frontline staff caring for acutely unwell adults.

QUALITY PROBLEM OR ISSUE: It is estimated that only 17% of patients survive an in-hospital cardiac arrest. Medical evidence indicates that many patients show signs of deterioration during the 24 h period prior to their cardiac arrest. INITIAL ASSESSMENT: At Salford Royal NHS Foundation Trust (SRFT) 135 patients (outside critical care areas) suffered a cardiac arrest between March 2007 and April 2008. CHOICE OF SOLUTION: Quality improvement method-The breakthrough series (BTS) collaborative approach, change package-reliable manual vital signs, nurse-led response to the deteriorating patient, code red, structured ward round, ceilings of care, nurse-led do not attempt cardiopulmonary resuscitation (DNA-CPR) protocol and allocated roles. IMPLEMENTATION: The project was delivered over two phases with a total of 23 wards (12 wards in Phase One and 11 wards in Phase Two). Frontline teams worked to develop changes with the aim of reducing cardiac arrests by 50%. EVALUATION: The primary outcome measure was the number of cardiac arrests per 1000 admissions outside of critical care areas. Process and balancing measures were also used to evaluate the impact of the intervention. LESSONS LEARNED: The results showed a positive relationship between the change package and a reduction of 41% in cardiac arrests outside of critical care areas from the baseline period (April 2007-March 2008) to December 2012. The BTS model has the potential to reduce cardiac arrests without the need for initial large-scale financial investment.

Improving Peer Online Forums (iPOF): protocol for a realist evaluation of peer online mental health forums to inform practice and policy.

INTRODUCTION: Peer online mental health forums are commonly used and offer accessible support. Positive and negative impacts have been reported by forum members and moderators, but it is unclear why these impacts occur, for whom and in which forums. This multiple method realist study explores underlying mechanisms to understand how forums work for different people. The findings will inform codesign of best practice guidance and policy tools to enhance the uptake and effectiveness of peer online mental health forums. METHODS AND ANALYSIS: In workstream 1, we will conduct a realist synthesis, based on existing literature and interviews with approximately 20 stakeholders, to generate initial programme theories about the impacts of forums on members and moderators and mechanisms driving these. Initial theories that are relevant for forum design and implementation will be prioritised for testing in workstream 2.Workstream 2 is a multiple case study design with mixed methods with several online mental health forums differing in contextual features. Quantitative surveys of forum members, qualitative interviews and Corpus-based Discourse Analysis and Natural Language Processing of forum posts will be used to test and refine programme theories. Final programme theories will be developed through novel triangulation of the data.Workstream 3 will run alongside workstreams 1 and 2. Key stakeholders from participating forums, including members and moderators, will be recruited to a Codesign group. They will inform the study design and materials, refine and prioritise theories, and codesign best policy and practice guidance. ETHICS AND DISSEMINATION: Ethical approval was granted by Solihull Research Ethics Committee (IRAS 314029). Findings will be reported in accordance with RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) guidelines, published as open access and shared widely, along with codesigned tools. TRIAL REGISTRATION NUMBER: ISRCTN 62469166; the protocol for the realist synthesis in workstream one is prospectively registered at PROSPERO CRD42022352528.

Collaborative working empowers staff to cut the number of cardiac arrests.

PROBLEM: At Salford Royal Foundation Trust, 179 patients suffered a cardiac arrest between March 2007 and April 2008. MAINE MEASURES FOR MPROVEMENT: Our primary outcome measure was the number of cardiac arrests per 1,000 admissions. STRATEGIES FOR CHANGE: Eleven wards were invited to participate in a Breakthrough Series collaborative from April 2008 to January 2009. It is a short term (6-15 months) learning system thatbrings together several teams to s eekimprovement, focusing on one topic. Frontline teams worked to develop changes in their clinical areas with the aim of reducing cardiac arrests by 50% in one year. RESULTS: April-December 2008 saw a reduction of 32% in the cardiac arrest rate, resulting in an average arrest rate of 0.79 per 1,000 admissions. Since the project began to upscale its work in January 2009, a further reduction has been noted. However,another 4 months' data is required to assess whether this equates to a sustained change. CONCLUSION: Preliminary data suggests that a Breakthrough Series collaborative is an effective method of engaging frontline staff in developing and implementing change, with improvements in patient care.

A bespoke smoking cessation service compared with treatment as usual for people with severe mental ill health: the SCIMITAR+ RCT.

BACKGROUND: There is a high prevalence of smoking among people with severe mental ill health (SMI). Helping people with SMI to quit smoking could improve their health and longevity, and reduce health inequalities. However, those with SMI are less likely to access and engage with routine smoking cessation services than the general population. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual stop smoking services for people with SMI. DESIGN: A pragmatic, two-arm, individually randomised controlled trial. SETTING: Primary care and secondary care mental health services in England. PARTICIPANTS: Smokers aged ≥ 18 years with SMI who would like to cut down on or quit smoking. INTERVENTIONS: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual care. MAIN OUTCOME MEASURES: The primary outcome was self-reported, CO-verified smoking cessation at 12 months. Smoking-related secondary outcomes were self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire. Other secondary outcomes were Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index measured at 6 and 12 months post randomisation. RESULTS: The trial randomised 526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years). About 60% of participants were male. Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline. The intervention group had a higher rate of exhaled CO-verified smoking cessation at 6 and 12 months than the usual-care group [adjusted odds ratio (OR) 12 months: 1.6, 95% confidence interval (CI) 0.9 to 2.8; adjusted OR 6 months: 2.4, 95% CI 1.2 to 4.7]. This was not statistically significant at 12 months (p = 0.12) but was statistically significant at 6 months (p = 0.01). In total, 111 serious adverse events were reported (69 in the BSC group and 42 in the usual-care group); the majority were unplanned hospitalisations due to a deterioration in mental health (n = 98). The intervention is likely (57%) to be less costly but more effective than usual care; however, this result was not necessarily associated with participants' smoking status. LIMITATIONS: Follow-up was not blind to treatment allocation. However, the primary outcome included a biochemically verified end point, less susceptible to observer biases. Some participants experienced difficulties in accessing nicotine replacement therapy because of changes in service provision. Efforts were made to help participants access nicotine replacement therapy, but this may have affected participants' quit attempt. CONCLUSIONS: People with SMI who received the intervention were more likely to have stopped smoking at 6 months. Although more people who received the intervention had stopped smoking at 12 months, this was not statistically significant. FUTURE WORK: Further research is needed to establish how quitting can be sustained among people with SMI. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72955454. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 50. See the NIHR Journals Library website for further project information.

Smoking is an important health issue, especially among people who have experienced mental ill health such as schizophrenia or bipolar disorder. This is because people with severe mental ill health (SMI) are more likely to smoke than the general population. Despite this, they are less likely to get help to stop smoking, and it may be that people with mental ill health problems need greater support to help them stop smoking. To address this problem, we developed and tested a 'bespoke smoking cessation' (BSC) service tailored to people with SMI. People aged ≥ 18 years who said that they would like to stop smoking were randomly allocated to either a BSC service or the usual stop smoking services. Those in the BSC service were allocated a mental health professional who had been trained to deliver smoking cessation interventions. The mental health professional worked with the participant and their care team to advise on stop smoking medication and provide information, support and motivation. Usual-care participants were signposted to local smoking services, but their subsequent care was not directly provided or supervised by trial smoking cessation advisors. Between October 2015 and December 2016, 526 people with SMI were recruited into the study: 265 of these people were randomly assigned to the BSC service and 261 were randomly assigned to usual care. At 6 and 12 months after randomisation, participants completed questionnaires that asked about their smoking status and health. Participants had their smoking status tested by measuring the amount of carbon monoxide in their breath. After 6 months, more people who received the BSC intervention had stopped smoking than those who had received usual care. At 12 months, the results were less clear in terms of the difference in the number of people who had stopped smoking. The BSC service cost less than or similar to usual care, when considering the overall health-care services. The improvement in health of people who received the BSC service remains uncertain. In addition, we do not know whether or not this was related to people stopping smoking.

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

BACKGROUND: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. METHODS: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. FINDINGS: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). INTERPRETATION: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Novel treatment options for lysosomal acid lipase deficiency: critical appraisal of sebelipase alfa.

Lysosomal acid lipase deficiency (LAL-D) is a rare disorder of cholesterol metabolism with an autosomal recessive mode of inheritance. The absence or deficiency of the LAL enzyme gives rise to pathological accumulation of cholesterol esters in various tissues. A severe LAL-D phenotype manifesting in infancy is associated with adrenal calcification and liver and gastrointestinal involvement with characteristic early mortality. LAL-D presenting in childhood and adulthood is associated with hepatomegaly, liver fibrosis, cirrhosis, and premature atherosclerosis. There are currently no curative pharmacological treatments for this life-threatening condition. Supportive management with lipid-modifying agents does not ameliorate disease progression. Hematopoietic stem cell transplantation as a curative measure in infantile disease has mixed success and is associated with inherent risks and complications. Sebelipase alfa (Kanuma) is a recombinant human LAL protein and the first enzyme replacement therapy for the treatment of LAL-D. Clinical trials have been undertaken in infants with rapidly progressive LAL-D and in children and adults with later-onset LAL-D. Initial data have shown significant survival benefits in the infant group and improvements in biochemical parameters in the latter. Sebelipase alfa has received marketing authorization in the United States and Europe as long-term therapy for all affected individuals. The availability of enzyme replacement therapy for this rare and progressive disorder warrants greater recognition and awareness by physicians.

Improving quality in a national intestinal failure unit: greater efficiency, improved access and reduced mortality.

PROBLEM: In 2010, there was a significant waiting list for admission to the intestinal failure unit (IFU) at the Salford Royal National Health Service (NHS) Foundation Trust. There had been a steady increase in the number of new patients referred to the IFU (89 patients 2005; 152 patients 2012) and the number of established patients requiring home parenteral nutrition (HPN) (135 patients 2005; 206 patients 2012) over the last decade. The impact of the resulting long waiting list for these complex patients was that patient deaths occurred in those awaiting admission. DESIGN: Continuous improvement methodology using the model for improvement and sequential plan-do-study-act cycles. SETTING: Salford Royal NHS Foundation Trust IFU; a large NHS teaching hospital in Northwest England. KEY MEASURES FOR IMPROVEMENT: The primary outcome measures were inpatient length of stay and time spent on waiting list prior to admission. STRATEGIES FOR CHANGE: A continuous improvement programme, supported by a project manager. RESULTS: There has been a 21% reduction in average length of stay on the IFU from 55.7 to 44.0 days and a reduction of 72% in the average length of time new patients spent on the waiting list for admission from 65.7 to 18.5 days. These changes were associated with concomitant reduction in 30-day readmission rate from 12.1% to 4.5% and early suggestions of reduced inpatient and waiting list mortality. CONCLUSIONS: It is possible to improve the efficiency of a large national service for complex patients using quality improvement methodology, resulting in improved access and reduced waiting list mortality.

Cognitive behaviour therapy for non-cardiac pain in the chest (COPIC): a multicentre randomized controlled trial with economic evaluation.

BACKGROUND: Most patients with chest pain have nothing wrong with their cardiac function. Psychological forms of treatment for this condition are more likely to be successful than others. METHODS/DESIGN: A two-arm parallel controlled randomized trial of standard care versus a modified form of cognitive behaviour therapy for chest pain (CBT-CP) in patients who have attended emergency hospital services. Inclusion criteria include (i) emergency attendance more than once in the previous year with chest pain when no physical pathology has been found, (ii) aged between 16 and 75, (iii) signed consent to take part in the study. Exclusion criteria are (i) under current psychiatric care, (ii) those who have had new psychotropic drugs prescribed within the last two months, (iii) are receiving or about to receive a formal psychological treatment. Those satisfying these criteria will be randomized to 4-10 sessions of CBT-CP or to continue with standard care. Participants are randomized using a remote web-based system using permuted stacked blocks stratified by study centre. Assessment is carried out at baseline by researchers subsequently masked to allocation and at 6 months and 1 year after randomization. The primary outcome is the Health Anxiety Inventory score at 6 months, and secondary outcomes are generalised anxiety and depressive symptoms, the Lucock Health Anxiety Questionnaire adapted for chest pain, visual analogue scales for chest pain and discomfort (Inskip Scale), the Schedule for Evaluating Persistent Symptoms (SEPS), health related quality of life, social functioning and medical resource usage. Intention to treat analyses will be carried out with clinical and functioning data, and a cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The data will also be linked to another parallel study in New Zealand where 126 patients with the same inclusion criteria have been treated in a similar trial; the form of analysis of the combined data has yet to be determined. DISCUSSION: The morbidity and costs of non-cardiac chest pain are substantial and if a simple psychological treatment given by health professionals working in medical departments is beneficial it should prove to be of great value. Combining data with a similar study in New Zealand is an additional asset. TRIAL REGISTRATION: ISRCTN14711101 (registered 05/03/2015).

Reducing Clostridium difficile infection in acute care by using an improvement collaborative.

PROBLEM: In 2006, despite a focus on infection control, Salford Royal had the fourth highest rate of Clostridium difficile infection in north west England. DESIGN: Interrupted time series in five collaborative wards (intervention group) and 35 non-collaborative wards (control group). SETTING: University teaching hospital with 850 acute beds. KEY MEASURES FOR IMPROVEMENT: Number of cases of C difficile infection per 1000 occupied bed days. STRATEGIES FOR CHANGE: In February 2007, a newly formed antimicrobial team led the implementation of revised guidelines in all wards and departments. From March to December 2007, five wards participated in an improvement collaborative. Since December 2007, the changes from the collaborative have been collated and implemented throughout the organisation. EFFECTS OF CHANGE: At baseline the non-collaborative wards had 1.15 (95% CI 1.03 to 1.29) cases per 1000 occupied bed days. In August 2007 cases reduced 56% from baseline (0.51, 0.44 to 0.60), which has been maintained since that time. In the collaborative wards, there were 2.60 (2.11 to 3.17) cases per 1000 occupied bed days at baseline. A shift occurred in April 2007 representing a reduction of 73% (0.69, 0.50 to 0.91) from baseline, which has been maintained. LESSONS LEARNT: Careful use of antimicrobial drugs is important in reducing the number of cases of C difficile infection. A collaborative learning model can enable teams to test and implement changes that can accelerate, amplify, and sustain control of C difficile.