Relationship between staff and quality of care in care homes: StaRQ mixed methods study.

Background: Quality of life and care varies between and within the care homes in which almost half a million older people live and over half a million direct care staff (registered nurses and care assistants) work. The reasons are complex, understudied and sometimes oversimplified, but staff and their work are a significant influence. Objective(s): To explore variations in the care home nursing and support workforce; how resident and relatives' needs in care homes are linked to care home staffing; how different staffing models impact on care quality, outcomes and costs; how workforce numbers, skill mix and stability meet residents' needs; the contributions of the care home workforce to enhancing quality of care; staff relationships as a platform for implementation by providers. Design: Mixed-method (QUAL-QUANT) parallel design with five work packages. WP1 - two evidence syntheses (one realist); WP2 - cross-sectional survey of routine staffing and rated quality from care home regulator; WP3 - analysis of longitudinal data from a corporate provider of staffing characteristics and quality indicators, including safety; WP4 - secondary analysis of care home regulator reports; WP5 - social network analysis of networks likely to influence quality innovation. We expressed our synthesised findings as a logic model. Setting: English care homes, with and without nursing, with various ownership structures, size and location, with varying quality ratings. Participants: Managers, residents, families and care home staff. Findings: Staffing's contribution to quality and personalised care requires: managerial and staff stability and consistency; sufficient staff to develop 'familial' relationships between staff and residents, and staff-staff reciprocity, 'knowing' residents, and skills and competence training beyond induction; supported, well-led staff seeing modelled behaviours from supervisors; autonomy to act. Outcome measures that capture the relationship between staffing and quality include: the extent to which resident needs and preferences are met and culturally appropriate; resident and family satisfaction; extent of residents living with purpose; safe care (including clinical outcomes); staff well-being and job satisfaction were important, but underacknowledged. Limitations: Many of our findings stem from self-reported and routine data with known biases - such as under reporting of adverse incidents; our analysis may reflect these biases. COVID-19 required adapting our original protocol to make it feasible. Consequently, the effects of the pandemic are reflected in our research methods and findings. Our findings are based on data from a single care home operator and so may not be generalised to the wider population of care homes. Conclusions: Innovative and multiple methods and theory can successfully highlight the nuanced relationship between staffing and quality in care homes. Modifiable characteristics such as visible philosophies of care and high-quality training, reinforced by behavioural and relational role modelling by leaders can make the difference when sufficient amounts of consistent staff are employed. Greater staffing capacity alone is unlikely to enhance quality in a cost-effective manner. Social network analysis can help identify the right people to aid adoption and spread of quality and innovation. Future research should focus on richer, iterative, evaluative testing and development of our logic model using theoretically and empirically defensible - rather than available - inputs and outcomes. Study registration: This study is registered as PROSPERO CRD42021241066 and Research Registry registration: 1062. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/144/29) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 8. See the NIHR Funding and Awards website for further award information.

This study was about the relationship between staffing and quality in care homes. Almost half a million older people live in care homes in England. Why quality of care and quality of life for residents vary so much between and within homes is unknown, but staff and the ways they work are likely to be important. Researching staffing and quality is difficult: quality means different things to different people and a lot of things shape how quality feels to residents, families and staff. In the past, researchers have oversimplified the problem to study it and may have missed important influences. We took a more complex view. In five interlinked work packages, we collected and analysed: (1) research journal articles; (2) national data from different care homes; (3) data from a large care organisation to look at what it is about staffing that influences quality; (4) reports and ratings of homes from the Care Quality Commission; and (5) we looked at the networks between staff in homes that shape how quality improvement techniques might spread. We used theories about how our findings might be linked to plan for this data collection and analysis. The results were combined into something called a 'logic model' ­ a diagram and explanation that make it easier for managers, researchers and people interested in care homes to see how staffing influences quality. Staffing considerations that might improve quality include: not swapping managers too much; having sufficient and consistent staff for family-like relationships in homes and putting residents' needs first; supporting staff and giving them freedom to act; and key staff leading by example. Research examining care home quality should capture those aspects that mean the most to residents, their families and staff.

Long-term catheter management in the community: a population-based analysis of user characteristics, service utilisation and costs in England.

BACKGROUND: Long-term urinary catheters are problematic and burdensome for patients, carers and health services. Nursing practice to improve the management of long-term urinary catheters has been held back by a lack of evidence to support policy and practice. Little is known about who uses a catheter long term and the resources and costs needed for their management. Understanding these costs will help to target innovations to improve care. There have been no substantial innovations to urinary catheters or their management recently and no publications to characterise users and costs. AIM: To describe long-term catheter users and explore catheter-related service use and costs in England. METHODS: Descriptive information on the characteristics of catheter users and their use of services was obtained from: General Practice records (n = 607), district nursing records (n = 303), questionnaires to patients (n = 333) and triangulated, 2009-2012. Annual service costs (British pounds 2011) were computed. FINDINGS: Most catheter users (59.6%) were men, nearly three-quarters (71.2%) were over 70 years and 60.8% used a urethral catheter. Women tended to be younger than men and more likely to use a suprapubic catheter. The services used most frequently over 12 months were general practitioner (by 63.1%) and out of hours services (43.0%); 15.5% accessed Accident and Emergency services for urgent catheter-related care. Hospital use accounted for nearly half (48.9%) of total health service costs (mainly due to inpatient stays by 13.6% of participants); catheter supplies/medications were next most costly (25.7%). Half of all costs were accounted for by 14.2% of users. The median annual cost of services used was £6.38, IQR: £344-£1324; district nursing services added approximately a further £200 per annum. CONCLUSIONS: Finding better ways to reduce catheter problems (e.g. blockage, infection) that cause unplanned visits, urgent or hospital care should be a priority to improve quality of life for long-term catheter users and reduce health service expenditure.

First Contact Physiotherapy: An evaluation of clinical effectiveness and costs.

BACKGROUND: First Contact Physiotherapy Practitioners (FCPPs) are embedded within general practice, providing expert assessment, diagnosis and management plans for patients with musculoskeletal disorders (MSKDs), without the prior need for GP consultation. AIM: To determine the clinical effectiveness and costs of FCPP-led compared to GP-led models of care. DESIGN AND SETTING: Multiple site case study design. UK GP practices. METHOD: General Practice sites were recruited representing three models: 1. GP-led care; 2. FCPPs who could not prescribe/inject (Standard (St)); 3. FCPPs who could prescribe/inject (Additional Qualifications (AQ)). Patient participants from each site completed clinical outcome data at baseline, 3 and 6 months. The primary outcome was the SF-36v.2 Physical Component Score (PCS). Healthcare usage was collected for 6 months. RESULTS: N=426 adults were recruited from 46 practices across the UK. Non-inferiority analysis showed no significant difference in physical function (SF36-PCS) across all three arms at 6 months (p=0.999). At 3 months a significant difference in numbers improving was seen between arms: 54.7% GP consultees; 72.4% FCPP-St, 66.4% FCPP-AQ; (p=0.037). No safety issues were identified. Following initial consultation, a greater proportion of patients received medication (including opioids) in the GP-led arm (44.7%) compared with FCPP-St (17.5%) and FCPP-AQ (22.8%); (p<0.001). NHS costs (initial consultation and over 6 months follow up) were significantly higher in the GP-led model (median £105.50) vs FCPP-St (£41) and FCPP-AQ (£44); (p<0.001). CONCLUSION: FCPP led models provide safe, clinically effective and cost-beneficial management for patients with MSKDs in general practice and reduced opioid use in this cohort.

The effect of general practice team composition and climate on staff and patient experiences: a systematic review.

BACKGROUND: Recent policy initiatives seeking to address the workforce crisis in general practice have promoted greater multidisciplinarity. Evidence is lacking on how changes in staffing and the relational climate in practice teams affect the experiences of staff and patients. AIM: To synthesise evidence on how the composition of the practice workforce and team climate affect staff job satisfaction and burnout, and the processes and quality of care for patients. DESIGN & SETTING: A systematic literature review of international evidence. METHOD: Four different searches were carried out using MEDLINE, Embase, Cochrane Library, CINAHL, PsycINFO, and Web of Science. Evidence from English language articles from 2012-2022 was identified, with no restriction on study design. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed and data were synthesised thematically. RESULTS: In total, 11 studies in primary healthcare settings were included, 10 from US integrated healthcare systems, one from Canada. Findings indicated that when teams are understaffed and work environments are stressful, patient care and staff wellbeing suffer. However, a good relational climate can buffer against burnout and protect patient care quality in situations of high workload. Good team dynamics and stable team membership are important for patient care coordination and job satisfaction. Female physicians are at greater risk of burnout. CONCLUSION: Evidence regarding team composition and team climate in relation to staff and patient outcomes in general practice remains limited. Challenges exist when drawing conclusions across different team compositions and definitions of team climate. Further research is needed to explore the conditions that generate a 'good' climate.

Integration, effectiveness and costs of different models of primary health care provision for people who are homeless: an evaluation study.

Background: There is a high prevalence of health problems among single people who are homeless. Specialist primary health care services for this population have been developed in several locations across England; however, there have been very few evaluations of these services. Objectives: This study evaluated the work of different models of primary health care provision in England to determine their effectiveness in engaging people who are homeless in health care and in providing continuity of care for long-term conditions. It concerned single people (not families or couples with dependent children) staying in hostels, other temporary accommodation or on the streets. The influence on outcomes of contextual factors and mechanisms (service delivery factors), including integration with other services, were examined. Data from medical records were collated on participants' use of health care and social care services over 12 months, and costs were calculated. Design and setting: The evaluation involved four existing Health Service Models: (1) health centres primarily for people who are homeless (Dedicated Centres), (2) Mobile Teams providing health care in hostels and day centres, (3) Specialist GPs providing some services exclusively for patients who are homeless and (4) Usual Care GPs providing no special services for people who are homeless (as a comparison). Two Case Study Sites were recruited for each of the specialist models, and four for the Usual Care GP model. Participants: People who had been homeless during the previous 12 months were recruited as 'case study participants'; they were interviewed at baseline and at 4 and 8 months, and information was collected about their circumstances and their health and service use in the preceding 4 months. Overall, 363 participants were recruited; medical records were obtained for 349 participants. Interviews were conducted with 65 Case Study Site staff and sessional workers, and 81 service providers and stakeholders. Results: The primary outcome was the extent of health screening for body mass index, mental health, alcohol use, tuberculosis, smoking and hepatitis A among participants, and evidence of an intervention if a problem was identified. There were no overall differences in screening between the models apart from Mobile Teams, which scored considerably lower. Dedicated Centres and Specialist GPs were more successful in providing continuity of care for participants with depression and alcohol and drug problems. Service use and costs were significantly higher for Dedicated Centre participants and lower for Usual Care GP participants. Participants and staff welcomed flexible and tailored approaches to care, and related services being available in the same building. Across all models, dental needs were unaddressed and staff reported poor availability of mental health services. Limitations: There were difficulties recruiting mainstream general practices for the Usual Care GP model. Medical records could not be accessed for 14 participants of this model. Conclusions: Participant characteristics, contextual factors and mechanisms were influential in determining outcomes. Overall, outcomes for Dedicated Centres and for one of the Specialist GP sites were relatively favourable. They had dedicated staff for patients who were homeless, 'drop-in' services, on-site mental health and substance misuse services, and worked closely with hospitals and homelessness sector services. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (HSDR 13/156/03) and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 16. See the NIHR Journals Library website for further project information.

Health problems are common among single people who are homeless, but there is little evidence of the best ways to deliver primary health care to them. This study evaluated four types of services (models) that are in existence: (1) health centres primarily for people who are homeless (Dedicated Centres); (2) Mobile Teams that provide health care in hostels and day centres; (3) Specialist GPs that have some services exclusively for patients who are homeless; and (4) Usual Care GPs providing health care to all patients, with no special services for people who are homeless. The study concentrated on single people (not homeless families or couples with dependent children) staying in hostels, other temporary accommodation and on the streets. Overall, 363 patients at these practices who had been homeless in the previous 12 months participated, and information was collected from them over a 12-month period. We examined the extent to which screening for different health conditions was undertaken, and to which treatment and follow-up care were provided for participants with chronic respiratory problems, depression, alcohol problems and drug problems. Information was gathered from their medical records about use of health and social care services over 12 months. Overall, outcomes for Dedicated Centres and for one of the Specialist GP sites were more favourable. They had staff working specifically with patients who were homeless; provided flexible 'drop-in' services instead of requiring patients to book appointments; and worked closely with mental health, alcohol and drug services, and with hostels, day centres and street outreach teams. Participants were also more satisfied with the health care they received from the specialist models, and were more likely to say that they had confidence and trust in doctors and nurses at these sites. Across all models, dental needs were unaddressed and staff reported poor availability of mental health services.

Family carer experiences of hospice care at home: Qualitative findings from a mixed methods realist evaluation.

BACKGROUND: Hospice-at-home aims to enable patients approaching end-of-life to die at home and support their carers. A wide range of different service models exists but synthesised evidence on how best to support family carers to provide sustainable end-of-life care at home is limited. AIM: To explore what works best to promote family carers' experiences of hospice-at-home. DESIGN: Realist evaluation with mixed methods. This paper focuses on qualitative interviews with carers (to gain their perspective and as proxy for patients) and service providers from 12 case study sites in England. Interviews were coded and programme theories were refined by the research team including two public members. SETTING/PARTICIPANTS: Interviews with carers (involved daily) of patients admitted to hospice-at-home services (n = 58) and hospice-at-home staff (n = 78). RESULTS: Post bereavement, 76.4% of carers thought that they had received as much help and support as they needed and most carers (75.8%) rated the help and support as excellent or outstanding. Of six final programme theories capturing key factors relevant to providing optimum services, those directly relevant to carer experiences were: integration and co-ordination of services; knowledge, skills and ethos of hospice staff; volunteer roles; support directed at the patient-carer dyad. CONCLUSIONS: Carers in hospice-at-home services identified care to be of a higher quality than generic community services. Hospice staff were perceived as having 'time to care', communicated well and were comfortable with dying and death. Hands-on care was particularly valued in the period close to death.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Dementia care coordinator service in Kent and Medway: a realist evaluation protocol.

BACKGROUND: Dementia care is a key priority for both NHS England and the UK government. National guidelines highlight the importance of care coordination to address the challenges people living with dementia and their carers can encounter when trying to access the health and care system. To counter these challenges, Kent and Medway Integrated Care Board (ICB) have recently implemented a proactive dementia care coordinator (DCC) service to support people with dementia and their carers from pre-diagnosis to end-of-life care. AIM: To understand how the DCC service works (or does not work), for whom, and in what circumstances. The findings will inform service development and future investment decisions. DESIGN & SETTING: This study will use a realist approach to evaluate the DCC service in Kent and Medway ICB, south-east England, which has a population of 1.9 million, comprising 42 primary care networks (PCNs; groups of general practices) each having a DCC. METHOD: An initial programme theory will be developed from existing literature, and in collaboration with stakeholders. Mixed methods, including questionnaires to DCCs, service provider metrics, and qualitative interviews, will be used to collect data on service provider and service user experiences. Interpretive comparative analysis and narrative synthesis, including evaluation of service costs against outcomes, will produce a refined final programme theory. RESULTS: The results from this project will produce evidence-based recommendations to help improve service delivery and possible service expansion. CONCLUSION: This protocol describes a realist evaluation designed to investigate the recently implemented DCC service in Kent and Medway ICB.

Comparative effectiveness of exercise electrocardiography versus exercise echocardiography in women presenting with suspected coronary artery disease: a randomized study.

Aims: There is a paucity of randomized diagnostic studies in women with suspected coronary artery disease (CAD). This study sought to assess the relative value of exercise stress echocardiography (ESE) compared with exercise electrocardiography (Ex-ECG) in women with CAD. Methods and results: Accordingly, 416 women with no prior CAD and intermediate probability of CAD (mean pre-test probability 41%), were randomized to undergo either Ex-ECG or ESE. The primary endpoints were the positive predictive value (PPV) for the detection of significant CAD and downstream resource utilization. The PPV of ESE and Ex-ECG were 33% and 30% (P = 0.87), respectively for the detection of CAD. There were similar clinic visits (36 vs. 29, P = 0.44) and emergency visits with chest pain (28 vs. 25, P = 0.55) in the Ex-ECG and ESE arms, respectively. At 2.9 years, cardiac events were 6 Ex-ECG vs. 3 ESE, P = 0.31. Although initial diagnosis costs were higher for ESE, more women underwent further CAD testing in the Ex-ECG arm compared to the ESE arm (37 vs. 17, P = 0.003). Overall, there was higher downstream resource utilization (hospital attendances and investigations) in the Ex-ECG arm (P = 0.002). Using National Health Service tariffs 2020/21 (British pounds) the cumulative diagnostic costs were 7.4% lower for Ex-ECG compared with ESE, but this finding is sensitive to the cost differential between ESE and Ex-ECG. Conclusion: In intermediate-risk women who are able to exercise, Ex-ECG had similar efficacy to an ESE strategy, with higher resource utilization whilst providing cost savings.

An observational study of individual child journeys through autism diagnostic pathways, and associated costs, in the UK National Health Service.

Background: Demand for diagnostic assessment in children with possible autism has recently increased significantly. Services are under pressure to deliver timely and high-quality diagnosis, following National Institute and Care Excellence multidisciplinary assessment guidelines. This UK National Health Service study aimed to answer: how many hours of health professional time are required to deliver autism diagnostic assessment, and how much does this cost?. Method: Case notes of 20 children (1-16 yrs.) from 27 NHS trusts, assessed through an autism diagnostic pathway in the previous year, were examined retrospectively. Data included: hours of professional time, diagnostic outcome. Assessment costs calculated using standardised NHS tariffs. Results: 488 children (aged 21-195 months, mean 82.9 months, SD 39.36) from 22 Child Development Services (CDS), four Child and Adolescent Mental Health Services (CAMHS) and one tertiary centre; 87% were either under 5 (36%) or 5 to 11 years (51%). Children seen by CDS were younger than CAMHS (mean (SD) 6.10 (2.72) vs. 10.39 (2.97) years, p < 0.001). Mean days to diagnosis were 375 (SD 235), with large variation (range 41-1553 days). Mean hours of professional time per child was 11.50 (SD 7.03) and varied substantially between services and individuals. Mean cost of assessment was £846.00 (SD 536.31). 339 (70.0%) children received autism diagnosis with or without comorbidity; 54 (11%) received no neurodevelopmental diagnosis; 91 (19%) received alternative neurodevelopmental diagnoses. Children with one or more coexisting conditions took longer to diagnose, and assessment was more costly, on average 117 days longer, costing £180 more than a child with no neurodevelopmental diagnosis. Age did not predict days to diagnosis or assessment costs. Conclusion: Typical assessment took 11 h of professional time and over 12-months to complete, costing GB£850 per child. Variation between centres and children reflect differences in practice and complexity of diagnostic presentation. These results give information to those delivering/planning autism assessments using multi-disciplinary team approach, in publicly funded health systems. Planning of future diagnostic services needs to consider growing demand, the need for streamlining, enabling context appropriate services, and child/family complexity.

Clinically assisted hydration in patients in the last days of life ('CHELsea II' trial): a cluster randomised trial.

INTRODUCTION: Provision of clinically assisted hydration (CAH) at the end of life is one of the most contentious issues in medicine. The aim of the 'CHELsea II' trial is to evaluate CAH in patients in the last days of life. The objectives are to assess the effect of CAH on delirium, audible upper airway secretions, pain and other symptoms, and overall survival, as well as the tolerability of CAH, and the health economic impact. METHODS AND ANALYSIS: The study is a cluster randomised trial, involving 80 sites/clusters (mainly hospices) and 1600 patients. Sites will be randomised to an intervention, and this will become the standard of care during the trial. Intervention 'A' involves continuance of drinking (if appropriate), mouth care and usual end-of-life care. Intervention 'B' involves continuance of drinking, mouth care, usual end-of-life care and CAH, that is, parenteral fluids. The fluid may be given intravenously or subcutaneously, the type will be dextrose saline (4% dextrose, 0.18% sodium chloride) and the volume will be dependent on weight.Participants will be assessed every 4 hours by the clinical team. The primary endpoint is the proportion of participants who develop delirium determined using the Nursing Delirium Screening Scale (using a cut-off score of ≥2). A mixed-effects logistic regression will be used to assess the difference in the odds of developing delirium between the interventions. ETHICS AND DISSEMINATION: Ethical committee approval has been granted by the Brighton and Sussex Research Ethics Committee (REC) (main REC for the UK: reference-IRAS 313640), and by the Scotland A REC (REC for adults with incapacity in Scotland: reference-22/SS/0053-IRAS-317637). The consent process follows the Mental Capacity Act: if the patient has capacity, then consent will be sought in the normal way; if the patient does not have capacity, then a personal/nominated consultee will be approached for advice about the patient entering the study. The consent process is slightly different in Scotland.The results of the trial will be published in general medical/palliative care journals, and presented at general medical/palliative care conferences. TRIAL REGISTRATION NUMBER: ISRCTN65858561.

Implementation of a medicine management plan (MMP) to reduce medication-related harm (MRH) in older people post-hospital discharge: a randomised controlled trial.

BACKGROUND: Medication-related harm (MRH) is an escalating global challenge especially among older adults. The period following hospital discharge carries high-risk for MRH due to medication discrepancies, limited patient/carer education and support, and poor communication between hospital and community professionals. Discharge Medical Service (DMS), a newly introduced NHS scheme, aims to reduce post-discharge MRH through an electronic communication between hospital and community pharmacists. Our study team has previously developed a risk-prediction tool (RPT) for MRH in the 8-weeks period post discharge from a UK hospital cohort of 1280 patients. In this study, we aim to find out if a Medicines Management Plan (MMP) linked to the DMS is more effective than the DMS alone in reducing rates of MRH. METHOD: Using a randomized control trial design, 682 older adults ≥ 65 years due to be discharged from hospital will be recruited from 4 sites. Participants will be randomized to an intervention arm (individualised medicine management plan (MMP) plus DMS) or a control arm (DMS only) using a 1:1 ratio stratification. Baseline data will include patients' clinical and social demographics, and admission and discharge medications. At 8-weeks post-discharge, a telephone interview and review of GP records by the study pharmacist will verify MRH in both arms. An economic and process evaluation will assess the cost and acceptability of the study methods. DATA ANALYSIS: Univariate analysis will be done for baseline variables comparing the intervention and control arms. A multivariate logistic regression will be done incorporating these variables. Economic evaluation will compare the cost-of-service use among the study arms and modelled to provide national estimates. Qualitative data from focus-group interviews will explore practitioners' understanding, and acceptance of the MMP, DMS and the RPT. CONCLUSION: This study will inform the use of an objective, validated RPT for MRH among older adults after hospital discharge, and provide a clinical, economic, and service evaluation of a specific medicines management plan alongside the DMS in the National Health Service (UK).

The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan.

BACKGROUND: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. METHODS: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. DISCUSSION: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. ETHICS AND DISSEMINATION: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations. TRIAL REGISTRATION: EudraCT 2016-001,350-18 . Registered on 14 April 2016. CLINICALTRIALS: gov NCT02949739 . Registered on 31 October 2016.

Overweight/Obesity and Time Preference: Evidence from a Survey among Adults in the UK.

INTRODUCTION: Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). METHODS: An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. RESULTS: A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. DISCUSSIONS/CONCLUSIONS: People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

Patient satisfaction with medication consultations and medicines information provided by nurses working autonomously in sexual health services: A questionnaire study.

AIM: To compare the satisfaction of patients managed by independent nurse prescribers with that of patients managed by nurses using PGDs with respect to experience of the consultation and information received about the medication. DESIGN: Survey. METHODS: Patients receiving medications from nurses in five urban sexual health services in the United Kingdom completed validated questionnaires immediately after the consultation, September 2015-August 2016. Scores of independent nurse prescribers and nurses using patient group directions were compared about consultation experience (5 items) Satisfaction with Information about Medicines (SIMS 16 items scale). RESULTS: Of 808 patients receiving medications, 393 (48.6%) received questionnaires and 380 were returned (independent nurse prescribers 180 of 198, 90.9%; patient group directions 173 of 195, 88.7%). Patients in both groups reported high levels of satisfaction. About the consultation experience, patients found nurses friendly/ approachable (>99%), instilling confidence and trust (>99%) and explaining reasons for medications clearly (97%). Satisfaction with medication information: Of 348 (92%) respondents completing SIMS, the overall mean score was 13.4 of maximum 16 (no difference between groups, t-test, p = .63). CONCLUSIONS: Patients were highly satisfied with nurse consultations and information around medications regardless of whether they were managed by independent nurse prescribers or nurses using patient group directions. IMPACT: Findings provide evidence in support of autonomous provision of medications by nurses in sexual health clinics.

Independent nurse medication provision: A mixed method study assessing impact on patients' experience, processes, and costs in sexual health clinics.

BACKGROUND: Local services in the United Kingdom National Health Service enable autonomous provision of medication by nurses, supporting individual nurses to gain prescribing qualifications or by introducing local patient group directions. AIM: To compare nurse prescribing and patient group directions about clinic processes, patients' experiences, and costs from the perspectives of providers, nurses, and patients. DESIGN: Mixed methods, comparative case study in five urban sexual health services in the United Kingdom. METHODS: Data were collected from nurse prescribers, patient group direction users and their patients July 2015 to December 2016. Nurse questionnaires explored training (funding and methods). Nurses recorded consultation durations and support from other professionals in clinical diaries. Patient notes were reviewed to explore medication provision, appropriateness and safety; errors were judged by an expert panel. Patients completed satisfaction questionnaires about consultations and information about medications. RESULTS: Twenty-eight nurse prescribers and 67 patient group directions users took part; records of 1682 consultations were reviewed, with 1357 medications prescribed and 98.5% therapeutically appropriate. Most medication decisions were deemed safe (96.0% nurse prescribers, 98.7% patient group directions, Fisher's Exact Test p = .55). Errors were predominantly minor (55.6% nurse prescribers, 62.4% patient group directions) and related to documentation omissions (78.0%); no patients were harmed. Consultation durations and unplanned re-consultations were similar for both groups. Nurse prescribers sought assistance from colleagues less frequently (chi-squared = 46.748, df = 1, p < .001) but spent longer discussing cases. Nurse prescribing training required more resources from providers and nurses, compared with patient group directions. Nurse prescribers were on higher salary bands. Patient satisfaction was high in both groups (>96%). CONCLUSIONS: Nurse medication provision by both nurse prescribers and patient group direction users is safe and associated with high patient satisfaction; effects on clinic processes and costs are similar. Undertaking the prescribing qualification involves independent study but may bring longer-term career progression to nurses.

The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial.

BACKGROUND: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. HYPOTHESIS: Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. DESIGN: Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. ENTRY CRITERIA: South Asian, men or women, age 40-70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0-6.4% inclusive). EXCLUSION CRITERIA: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. ENDPOINTS: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. INTERVENTION: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. RESULTS: We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). CONCLUSION: The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB APPROVAL: 16/WM/0171 TRIAL REGISTRATION: EudraCT 2016-001350-18 . Registered on 14 April 2016. ClinicalTrials.gov NCT02949739 . Registered on 31 October 2016, First posted on 31/10/2016.

Effects of a lifestyle intervention programme after 1 year of follow-up among South Asians at high risk of type 2 diabetes: a cluster randomised controlled trial.

INTRODUCTION: South Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D. METHODS: This cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40-70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values. RESULTS: There were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference -1.10 kg (95% CI -1.70 to -1.06), p<0.001). The adjusted mean difference for waist circumference was -1.9 cm (95% CI -2.5; to 1.3), p<0.001). No overall difference was observed for blood pressure or HbA1c. People who attended multiple intervention sessions had a dose-dependent effect on waist circumference, blood pressure and HbA1c, but not on weight. CONCLUSION: An intensive family-based lifestyle intervention adopting low-resource strategies led to effective reduction in weight and waist circumference at 12 months, which has potential long-term benefits for preventing T2D. A higher number of attended sessions increased the effect on waist circumference, blood pressure and HbA1c. TRIAL REGISTRATION NUMBER: EudraCT: 2016-001350-18; ClinicalTrials.gov: NCT02949739.

Unmet supportive care needs of breast, colorectal and testicular cancer survivors in the first 8 months post primary treatment: A prospective longitudinal survey.

OBJECTIVES: To explore the supportive care needs of cancer survivors, the characteristics of patients with high levels of unmet need, changes in unmet need after treatment ends and differences in unmet needs of breast, colorectal and testicular survivors. METHODS: The method used was a prospective longitudinal mailed survey. Unmet needs, measured by 25-item modified Cancer Survivors Unmet Needs survey at baseline (immediately post-treatment) and 8 months later, were analysed descriptively. RESULTS: Of 434 breast, 186 colorectal and 75 testicular patients responding at baseline, 56.2%, 65.6% and 50.7%, respectively, had no unmet needs, the top decile having ≥10 (breast) or seven (colorectal and testicular) different needs and seven different unmet needs. The most frequently reported unmet need (all groups) was fear of cancer recurrence. Unmet needs fell significantly at 8 months for breast patients. Some patients reported new needs. Needs were lowest amongst colorectal survivors and differed between the three groups. Higher levels of unmet needs (breast and colorectal) were associated with having had chemotherapy. CONCLUSION: Most survivors reported few unmet needs, but a small proportion have persisting or emerging needs. Routine or regular monitoring of unmet needs is required so that healthcare professionals can deliver personalised care based on individual needs, preferences and circumstances.

A feasibility trial of an intervention in alcohol dependence for structured preparation before detoxification versus usual care: the SPADe trial results.

BACKGROUND: Individuals who are 'moderately' or 'severely' dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members) and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? METHODS: This is a pragmatic, parallel, two-arm, feasibility RCT comparing SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. RESULTS: We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial for the whole period of the 12 months was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months, respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n = 54.5) versus control (n = 41.5). CONCLUSIONS: The results of this feasibility trial indicate that with the appropriate modifications, a full multicentred trial would be possible to test the effectiveness and cost-effectiveness of a pre-habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. TRIAL REGISTRATION: Name of registry: ISRCTN; Trial Registration Number: 14621127 ; Date of Registration: 22/02/2017.