Programme Grants for Applied Research

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ISSN / EISSN : 2050-4322 / 2050-4330
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Martin J Wildman, , , Chin Maguire, , Marlene Hutchings, , , , , et al.
Programme Grants for Applied Research, Volume 9, pp 1-146;

Background People with cystic fibrosis frequently have low levels of adherence to inhaled medications. Objectives The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication. Design We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis. Setting The randomised controlled trial took place in 19 UK cystic fibrosis centres. Participants Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers. Intervention People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence. Main outcome measures Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained. Results Randomised controlled trial – 608 participants were randomised to the intervention (n = 305) or usual care (n = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1 year, favouring the intervention. Adjusted mean difference in forced expiratory volume in 1 second (per cent) predicted at 12 months was 1.4% (95% confidence interval –0.2% to 3.0%). No adverse events were related to the intervention. Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites. Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists. Economic modelling – the within-trial analysis suggests that the intervention generated 0.01 additional quality-adjusted life-years at an additional cost of £865.91 per patient, leading to an incremental cost-effectiveness ratio of £71,136 per quality-adjusted life-year gained. This should be interpreted with caution owing to the short time horizon. The health economic model suggests that the intervention is expected to generate 0.17 additional quality-adjusted life-years and cost savings of £1790 over a lifetime (70-year) horizon; hence, the intervention is expected to dominate usual care. Assuming a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, the probability that the intervention generates more net benefit than usual care is 0.89. The model results are dependent on assumptions regarding the duration over which costs and effects of the intervention apply, the impact of the intervention on forced expiratory volume in 1 second (per cent) predicted and the relationship between increased adherence and drug-prescribing levels. Limitations Number of exacerbations is a sensitive and valid measure of clinical change used in many trials. However, data collection of this outcome in this context was challenging and could have been subject to bias. It was not possible to measure baseline adherence accurately. It was not possible to quantify the impact of the intervention on the number of packs of medicines prescribed. Conclusions We developed a feasible and acceptable intervention that was delivered to fidelity in the randomised controlled trial. We observed no statistically significant difference in the primary outcome of exacerbation rates over 12 months. We observed an increase in normative adherence levels in a disease where adherence levels are low. The magnitude of the increase in adherence may not have been large enough to affect exacerbations. Future work Given the non-significant difference in the primary outcome, further research is required to explore why an...
Programme Grants for Applied Research, Volume 9, pp 1-218;

Background Long-term monitoring is important in chronic condition management. Despite considerable costs of monitoring, there is no or poor evidence on how, what and when to monitor. The aim of this study was to improve understanding, methods, evidence base and practice of clinical monitoring in primary care, focusing on two areas: chronic kidney disease and chronic heart failure. Objectives The research questions were as follows: does the choice of test affect better care while being affordable to the NHS? Can the number of tests used to manage individuals with early-stage kidney disease, and hence the costs, be reduced? Is it possible to monitor heart failure using a simple blood test? Can this be done using a rapid test in a general practitioner consultation? Would changes in the management of these conditions be acceptable to patients and carers? Design Various study designs were employed, including cohort, feasibility study, Clinical Practice Research Datalink analysis, seven systematic reviews, two qualitative studies, one cost-effectiveness analysis and one cost recommendation. Setting This study was set in UK primary care. Data sources Data were collected from study participants and sourced from UK general practice and hospital electronic health records, and worldwide literature. Participants The participants were NHS patients (Clinical Practice Research Datalink: 4.5 million patients), chronic kidney disease and chronic heart failure patients managed in primary care (including 750 participants in the cohort study) and primary care health professionals. Interventions The interventions were monitoring with blood and urine tests (for chronic kidney disease) and monitoring with blood tests and weight measurement (for chronic heart failure). Main outcome measures The main outcomes were the frequency, accuracy, utility, acceptability, costs and cost-effectiveness of monitoring. Results Chronic kidney disease: serum creatinine testing has increased steadily since 1997, with most results being normal (83% in 2013). Increases in tests of creatinine and proteinuria correspond to their introduction as indicators in the Quality and Outcomes Framework. The Chronic Kidney Disease Epidemiology Collaboration equation had 2.7% greater accuracy (95% confidence interval 1.6% to 3.8%) than the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate. Estimated annual transition rates to the next chronic kidney disease stage are ≈ 2% for people with normal urine albumin, 3–5% for people with microalbuminuria (3–30 mg/mmol) and 3–12% for people with macroalbuminuria (> 30 mg/mmol). Variability in estimated glomerular filtration rate-creatinine leads to misclassification of chronic kidney disease stage in 12–15% of tests in primary care. Glycaemic-control and lipid-modifying drugs are associated with a 6% (95% confidence interval 2% to 10%) and 4% (95% confidence interval 0% to 8%) improvement in renal function, respectively. Neither estimated glomerular filtration rate-creatinine nor estimated glomerular filtration rate-Cystatin C have utility in predicting rate of kidney function change. Patients viewed phrases such as ‘kidney damage’ or ‘kidney failure’ as frightening, and the term ‘chronic’ was misinterpreted as serious. Diagnosis of asymptomatic conditions (chronic kidney disease) was difficult to understand, and primary care professionals often did not use ‘chronic kidney disease’ when managing patients at early stages. General practitioners relied on Clinical Commissioning Group or Quality and Outcomes Framework alerts rather than National Institute for Health and Care Excellence guidance for information. Cost-effectiveness modelling did not demonstrate a tangible benefit of monitoring kidney function to guide preventative treatments, except for individuals with an estimated glomerular filtration rate of 60–90 ml/minute/1.73 m2, aged < 70 years and without cardiovascular disease, where monitoring every 3–4 years to guide cardiovascular prevention may be cost-effective. Chronic heart failure: natriuretic peptide-guided treatment could reduce all-cause mortality by 13% and heart failure admission by 20%. Implementing natriuretic peptide-guided treatment is likely to require predefined protocols, stringent natriuretic peptide targets, relative targets and being located in a specialist heart failure setting. Remote monitoring can reduce all-cause mortality and heart failure hospitalisation, and could improve quality of life. Diagnostic accuracy of point-of-care N-terminal prohormone of B-type natriuretic peptide (sensitivity, 0.99; specificity, 0.60) was better than point-of-care B-type natriuretic peptide (sensitivity, 0.95; specificity, 0.57). Within-person variation estimates for B-type natriuretic peptide and weight were as follows: coefficient of variation, 46% and coefficient of variation, 1.2%, respectively. Point-of-care N-terminal prohormone of B-type natriuretic peptide within-person variability over 12 months was 881 pg/ml (95% confidence interval 380 to 1382 pg/ml), whereas between-person variability was 1972 pg/ml (95% confidence interval 1525 to 2791 pg/ml). For individuals, monitoring provided reassurance; future changes, such as increased testing, would be acceptable. Point-of-care testing in general practice surgeries was perceived positively, reducing waiting time and anxiety. Community heart failure nurses had greater knowledge of National Institute for Health and Care Excellence guidance than general practitioners and practice nurses. Health-care professionals believed that the cost of natriuretic peptide tests in routine monitoring would outweigh potential benefits. The review of cost-effectiveness studies suggests that natriuretic peptide-guided treatment is cost-effective in specialist settings, but with no evidence for its value in primary care...
, , , , , Rhiannon R Baggott, Ailsa Bosworth, , Sofia Georgopoulou, Naomi Martin, et al.
Programme Grants for Applied Research, Volume 9, pp 1-186;

Background Rheumatoid arthritis is a major inflammatory disorder and causes substantial disability. Treatment goals span minimising disease activity, achieving remission and decreasing disability. In active rheumatoid arthritis, intensive management achieves these goals. As many patients with established rheumatoid arthritis have moderate disease activity, the TITRATE (Treatment Intensities and Targets in Rheumatoid Arthritis ThErapy) programme assessed the benefits of intensive management. Objectives To (1) define how to deliver intensive therapy in moderate established rheumatoid arthritis; (2) establish its clinical effectiveness and cost-effectiveness in a trial; and (3) evaluate evidence supporting intensive management in observational studies and completed trials. Design Observational studies, secondary analyses of completed trials and systematic reviews assessed existing evidence about intensive management. Qualitative research, patient workshops and systematic reviews defined how to deliver it. The trial assessed its clinical effectiveness and cost-effectiveness in moderate established rheumatoid arthritis. Setting Observational studies (in three London centres) involved 3167 patients. These were supplemented by secondary analyses of three previously completed trials (in centres across all English regions), involving 668 patients. Qualitative studies assessed expectations (nine patients in four London centres) and experiences of intensive management (15 patients in 10 centres across England). The main clinical trial enrolled 335 patients with diverse socioeconomic deprivation and ethnicity (in 39 centres across all English regions). Participants Patients with established moderately active rheumatoid arthritis receiving conventional disease-modifying drugs. Interventions Intensive management used combinations of conventional disease-modifying drugs, biologics (particularly tumour necrosis factor inhibitors) and depot steroid injections; nurses saw patients monthly, adjusted treatment and provided supportive person-centred psychoeducation. Control patients received standard care. Main outcome measures Disease Activity Score for 28 joints based on the erythrocyte sedimentation rate (DAS28-ESR)-categorised patients (active to remission). Remission (DAS28-ESR < 2.60) was the treatment target. Other outcomes included fatigue (measured on a 100-mm visual analogue scale), disability (as measured on the Health Assessment Questionnaire), harms and resource use for economic assessments. Results Evaluation of existing evidence for intensive rheumatoid arthritis management showed the following. First, in observational studies, DAS28-ESR scores decreased over 10–20 years, whereas remissions and treatment intensities increased. Second, in systematic reviews of published trials, all intensive management strategies increased remissions. Finally, patients with high disability scores had fewer remissions. Qualitative studies of rheumatoid arthritis patients, workshops and systematic reviews helped develop an intensive management pathway. A 2-day training session for rheumatology practitioners explained its use, including motivational interviewing techniques and patient handbooks. The trial screened 459 patients and randomised 335 patients (168 patients received intensive management and 167 patients received standard care). A total of 303 patients provided 12-month outcome data. Intention-to-treat analysis showed intensive management increased DAS28-ESR 12-month remissions, compared with standard care (32% vs. 18%, odds ratio 2.17, 95% confidence interval 1.28 to 3.68; p = 0.004), and reduced fatigue [mean difference –18, 95% confidence interval –24 to –11 (scale 0–100); p < 0.001]. Disability (as measured on the Health Assessment Questionnaire) decreased when intensive management patients achieved remission (difference –0.40, 95% confidence interval –0.57 to –0.22) and these differences were considered clinically relevant. However, in all intensive management patients reductions in the Health Assessment Questionnaire scores were less marked (difference –0.1, 95% confidence interval –0.2 to 0.0). The numbers of serious adverse events (intensive management n = 15 vs. standard care n = 11) and other adverse events (intensive management n = 114 vs. standard care n = 151) were similar. Economic analysis showed that the base-case incremental cost-effectiveness ratio was £43,972 from NHS and Personal Social Services cost perspectives. The probability of meeting a willingness-to-pay threshold of £30,000 was 17%. The incremental cost-effectiveness ratio decreased to £29,363 after including patients’ personal costs and lost working time, corresponding to a 50% probability that intensive management is cost-effective at English willingness-to-pay thresholds. Analysing trial baseline predictors showed that remission predictors comprised baseline DAS28-ESR, disability scores and body mass index. A 6-month extension study (involving 95 intensive management patients) showed fewer remissions by 18 months, although more sustained remissions were more likley to persist. Qualitative research in trial completers showed that intensive management was acceptable and treatment support from specialist nurses was beneficial. Limitations The main limitations comprised (1) using single time point remissions rather than sustained responses, (2) uncertainty about benefits of different aspects of intensive management and differences in its delivery across centres, (3) doubts about optimal treatment of patients unresponsive to intensive management and (4) the lack of formal international definitions of ‘intensive management’. Conclusion The benefits of intensive management need to be set against its additional costs. These were relatively high. Not all patients benefited. Patients with high pretreatment physical disability or who...
, , , Nicola McMaster, Jennifer Airlie, , , Rebecca Hawkins, , , et al.
Programme Grants for Applied Research, Volume 9, pp 1-314;

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.
Programme Grants for Applied Research, Volume 9, pp 1-120;

Background Lewy body dementia, comprising both dementia with Lewy bodies and Parkinson’s disease dementia, is the second commonest cause of neurodegenerative dementia. Existing evidence suggests that it is underdiagnosed and without a consistent approach to management. Objectives To improve the diagnosis and management of Lewy body dementia by (1) understanding current diagnostic practice for dementia with Lewy bodies and Parkinson’s disease dementia; (2) identifying barriers to and facilitators of diagnosis and management; (3) developing evidence-based assessment toolkits to improve diagnosis of dementia with Lewy bodies and Parkinson’s disease dementia; (4) producing a management toolkit to facilitate management; and (5) undertaking a pilot cluster randomised clinical trial. Design Work package 1 assessed clinical diagnostic rates from case notes for dementia with Lewy bodies and Parkinson’s disease dementia before and after (work package 1 repeated) introduction of an assessment toolkit. In work package 2, we developed a management toolkit for Lewy body dementia. In work package 3, we developed assessment toolkits for dementia with Lewy bodies and Parkinson’s disease dementia and piloted these and the management toolkit in a clinical service. In work package 4, we undertook a pilot study of 23 services in nine NHS trusts that were cluster randomised to receiving and using the management toolkit or standard care. Work package 5 comprised a series of qualitative studies, examining barriers to and facilitators of diagnosis and management. Setting Secondary care memory assessment and movement disorder services in England. Interventions Assessment toolkits for Lewy body dementia consisted of questions for diagnostic symptoms, and management toolkits comprised 161 guidance statements grouped under five symptom domains. Review methods The systematic reviews of pharmacological and non-pharmacological management were based on published literature, with meta-analysis when possible, following a search of several electronic databases and the grey literature using terms related to Lewy body dementia, without restriction on time or language. Participants Participants aged ≥ 50 years diagnosed with dementia with Lewy bodies or Parkinson’s disease dementia and, for work package 1 and work package 1 repeated, non-dementia with Lewy bodies and non-Parkinson’s disease dementia controls. The qualitative studies included people with Lewy body dementia, carers and professionals. Main outcome measures For work packages 1 and 1 repeated, diagnostic rates for dementia with Lewy bodies and Parkinson’s disease dementia as a proportion of all dementia or Parkinson’s disease. For work packages 2 and 3, the production of diagnostic and management toolkits. For work package 4, feasibility of undertaking a cluster randomised trial of the toolkits, measured by number of participants recruited and use of the toolkits, assessed qualitatively. Results Work package 1 – 4.6% of dementia cases in secondary care received a dementia with Lewy bodies diagnosis (with significant differences in diagnostic rates between services) and 9.7% of those with Parkinson’s disease had a diagnosis of Parkinson’s disease dementia. There was evidence of delays in diagnosis for both dementia with Lewy bodies and Parkinson’s disease dementia compared with control patients, and the costs of dementia with Lewy bodies and Parkinson’s disease dementia were also greater than those for matched controls (p < 0.01 for both). Work package 2 – we produced 252 statements regarding Lewy body dementia management and, following a Delphi process, 161 statements were included in a management toolkit. Work package 3 – piloting indicated that separate assessment toolkits for use in memory clinic and movement disorder services were preferred, but a single toolkit for Lewy body dementia management was suitable. Work package 4 – we were able to recruit Lewy body dementia patients to target and recruited 131 patients within 6 months (target n = 120), of whom > 80% were retained in the study at 6 months. Work package 5 – barriers to diagnosis and management of Lewy body dementia were complex. Managing Lewy body dementia often requires input from a range of specialties and, therefore, care pathways may be fragmented. Positive attitudes to diagnosing Lewy body dementia, working with a team with expertise in Lewy body dementia and opportunities for cross-specialty discussion of patients with complex needs facilitated diagnosis and management. The toolkits were generally well received, particularly the management toolkit. Implementation, however, varied, reflecting differences in attitudes, skills, time and local leadership. Work package 1 repeated – following introduction of the assessment toolkit, we found that 9.7% of dementia cases had dementia with Lewy bodies (a significant increase from baseline; p = 0.0019), but Parkinson’s disease dementia rates were similar (8.2%) to baseline. Limitations We included only two geographical regions and evidence informing the management toolkit was limited. Work package 4 was a pilot study and, therefore, we did not set out to assess the extent to which use of the management toolkit altered outcomes at the individual patient level. We noted implementation of the toolkits was variable. The increase in diagnostic rates in dementia with Lewy bodies following introduction of the assessment toolkits cannot be necessarily causally attributed to them. Conclusions Dementia with Lewy bodies and Parkinson’s disease dementia were diagnosed in secondary care NHS services, with a lower frequency (around half) than that expected from known prevalence rates. The introduction of assessment toolkits for dementia with Lewy bodies and Parkinson’s disease dementia was associated with increased diagnostic rates...
Programme Grants for Applied Research, Volume 9, pp 1-132;

Background Over half of people with dementia live at home. We know little about what home support could be clinically effective or cost-effective in enabling them to live well. Objectives We aimed to (1) review evidence for components of home support, identify their presence in the literature and in services in England, and develop an appropriate economic model; (2) develop and test a practical memory support package in early-stage dementia, test the clinical effectiveness and cost-effectiveness of routine home support in later-stage dementia and design a toolkit based on this evidence; and (3) elicit the preferences of staff, carers and people with dementia for home support inputs and packages, and evaluate the cost-effectiveness of these approaches in early- and later-stage dementia. Design We undertook (1) an evidence synthesis, national surveys on the NHS and social care and an economic review; (2) a multicentre pragmatic randomised trial [Dementia Early Stage Cognitive Aids New Trial (DESCANT)] to estimate the clinical effectiveness and cost-effectiveness of providing memory aids and guidance to people with early-stage dementia (the DESCANT intervention), alongside process evaluation and qualitative analysis, an observational study of existing care packages in later-stage dementia along with qualitative analysis, and toolkit development to summarise this evidence; and (3) consultation with experts, staff and carers to explore the balance between informal and paid home support using case vignettes, discrete choice experiments to explore the preferences of people with dementia and carers between home support packages in early- and later-stage dementia, and cost–utility analysis building on trial and observational study. Setting The national surveys described Community Mental Health Teams, memory clinics and social care services across England. Recruitment to the trial was through memory services in nine NHS trusts in England and one health board in Wales. Recruitment to the observational study was through social services in 17 local authorities in England. Recruitment for the vignette and preference studies was through memory services, community centres and carers’ organisations. Participants People aged > 50 years with dementia within 1 year of first attendance at a memory clinic were eligible for the trial. People aged > 60 years with later-stage dementia within 3 months of a review of care needs were eligible for the observational study. We recruited staff, carers and people with dementia for the vignette and preference studies. All participants had to give written informed consent. Main outcome measures The trial and observational study used the Bristol Activities of Daily Living Scale as the primary outcome and also measured quality of life, capability, cognition, general psychological health and carers’ sense of competence. Methods Owing to the heterogeneity of interventions, methods and outcome measures, our evidence and economic reviews both used narrative synthesis. The main source of economic studies was the NHS Economic Evaluation Database. We analysed the trial and observational study by linear mixed models. We analysed the trial by ‘treatment allocated’ and used propensity scores to minimise confounding in the observational study. Results Our reviews and surveys identified several home support approaches of potential benefit. In early-stage dementia, the DESCANT trial had 468 randomised participants (234 intervention participants and 234 control participants), with 347 participants analysed. We found no significant effect at the primary end point of 6 months of the DESCANT intervention on any of several participant outcome measures. The primary outcome was the Bristol Activities of Daily Living Scale, for which scores range from 0 to 60, with higher scores showing greater dependence. After adjustment for differences at baseline, the mean difference was 0.38, slightly but not significantly favouring the comparator group receiving treatment as usual. The 95% confidence interval ran from –0.89 to 1.65 (p = 0.56). There was no evidence that more intensive care packages in later-stage dementia were more effective than basic care. However, formal home care appeared to help keep people at home. Staff recommended informal care that cost 88% of formal care, but for informal carers this ratio was only 62%. People with dementia preferred social and recreational activities, and carers preferred respite care and regular home care. The DESCANT intervention is probably not cost-effective in early-stage dementia, and intensive care packages are probably not cost-effective in later-stage dementia. From the perspective of the third sector, intermediate intensity packages were cheaper but less effective. Certain elements may be driving these results, notably reduced use of carers’ groups. Limitations Our chosen outcome measures may not reflect subtle outcomes valued by people with dementia. Conclusions Several approaches preferred by people with dementia and their carers have potential. However, memory aids aiming to affect daily living activities in early-stage dementia or intensive packages compared with basic care in later-stage dementia were not clinically effective or cost-effective. Future work Further work needs to identify what people with dementia and their carers prefer and develop more sensitive outcome measures. Study registration Current Controlled Trials ISRCTN12591717. The evidence synthesis is registered as PROSPERO CRD42014008890. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 6. See the NIHR Journals Library website for further project information.
, Emma Wilson, , , , Thai-Son Tong, , , , Helen Buckley Woods, et al.
Programme Grants for Applied Research, Volume 9, pp 1-150;

Background Vascular services is changing rapidly, having emerged as a new specialty with its own training and specialised techniques. This has resulted in the need for reconfiguration of services to provide adequate specialist provision and accessible and equitable services. Objectives To identify the effects of service configuration on practice, resource use and outcomes. To model potential changes in configuration. To identify and/or develop electronic data collection tools for collecting patient-reported outcome measures and other clinical information. To evaluate patient preferences for aspects of services other than health-related quality of life. Design This was a multiple methods study comprising multiple systematic literature reviews; the development of a new outcome measure for users of vascular services (the electronic Personal Assessment Questionnaire – Vascular) based on the reviews, qualitative studies and psychometric evaluation; a trade-off exercise to measure process utilities; Hospital Episode Statistics analysis; and the development of individual disease models and a metamodel of service configuration. Setting Specialist vascular inpatient services in England. Data sources Modelling and Hospital Episode Statistics analysis for all vascular inpatients in England from 2006 to 2018. Qualitative studies and electronic Personal Assessment Questionnaire – Vascular evaluation with vascular patients from the Sheffield area. The trade-off studies were based on a societal sample from across England. Interventions The data analysis, preference studies and modelling explored the effect of different potential arrangements for service provision on the resource use, workload and outcomes for all interventions in the three main areas of inpatient vascular treatment: peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease. The electronic Personal Assessment Questionnaire – Vascular was evaluated as a potential tool for clinical data collection and outcome monitoring. Main outcome measures Systematic reviews assessed quality and psychometric properties of published outcome measures for vascular disease and the relationship between volume and outcome in vascular services. The electronic Personal Assessment Questionnaire – Vascular development considered face and construct validity, test–retest reliability and responsiveness. Models were validated using case studies from previous reconfigurations and comparisons with Hospital Episode Statistics data. Preference studies resulted in estimates of process utilities for aneurysm treatment and for travelling distances to access services. Results Systematic reviews provided evidence of an association between increasing volume of activity and improved outcomes for peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease. Reviews of existing patient-reported outcome measures did not identify suitable condition-specific tools for incorporation in the electronic Personal Assessment Questionnaire – Vascular. Reviews of qualitative evidence, primary qualitative studies and a Delphi exercise identified the issues to be incorporated into the electronic Personal Assessment Questionnaire – Vascular, resulting in a questionnaire with one generic and three disease-specific domains. After initial item reduction, the final version has 55 items in eight scales and has acceptable psychometric properties. The preference studies showed strong preference for endovascular abdominal aortic aneurysm treatment (willingness to trade up to 0.135 quality-adjusted life-years) and for local services (up to 0.631 quality-adjusted life-years). A simulation model with a web-based interface was developed, incorporating disease-specific models for abdominal aortic aneurysm, peripheral arterial disease and carotid artery disease. This predicts the effects of specified reconfigurations on workload, resource use, outcomes and cost-effectiveness. Initial exploration suggested that further reconfiguration of services in England to accomplish high-volume centres would result in improved outcomes, within the bounds of cost-effectiveness usually considered acceptable in the NHS. Limitations The major source of evidence to populate the models was Hospital Episode Statistics data, which have limitations owing to the complexity of the data, deficiencies in the coding systems and variations in coding practice. The studies were not able to address all of the potential barriers to change where vascular services are not compliant with current NHS recommendations. Conclusions There is evidence of potential for improvement in the clinical effectiveness and cost-effectiveness of vascular services through further centralisation of sites where major vascular procedures are undertaken. Preferences for local services are strong, and this may be addressed through more integrated services, with a range of services being provided more locally. The use of a web-based tool for the collection of clinical data and patient-reported outcome measures is feasible and can provide outcome data for clinical use and service evaluation. Future work Further evaluation of the economic models in real-world situations where local vascular service reconfiguration is under consideration and of the barriers to change where vascular services do not meet NHS recommendations for service configuration is needed. Further work on the electronic Personal Assessment Questionnaire – Vascular is required to assess its acceptability and usefulness in clinical practice and to develop appropriate report formats for clinical use and service evaluation. Further studies to assess the implications of including non-health-related preferences for care processes, and location of services, in calculations of cost-effectiveness are required. Study registration This study is registered as PROSPERO CRD42016042570, CRD42016042573,...
, , , , , Elaine Roberts, , Gill Carter, , Matthew Fay, et al.
Programme Grants for Applied Research, Volume 9, pp 1-268;

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.
, , , Jane Smith, Francine Cheater, , Michelle Collinson, , Shamaila Anwar, Marie Fletcher, et al.
Programme Grants for Applied Research, Volume 9, pp 1-180;

Background Delirium is a distressing, common and serious condition in older people in hospital. Evidence suggests that it could be prevented in about one-third of patients using multicomponent interventions targeting delirium risk factors, but these interventions are not yet routinely available in the NHS. Objective The objective was to improve delirium prevention for older people admitted to the NHS. Design Project 1 comprised case studies employing qualitative methods (observation, interviews, workshops) in three NHS hospitals to develop the Prevention of Delirium system of care. Project 2 comprised case studies using mixed methods in five NHS hospitals to test the Prevention of Delirium implementation, feasibility and acceptability, and to modify the Prevention of Delirium system of care. Project 3 comprised a multicentre, cluster randomised, controlled, pragmatic feasibility study in eight hospitals, with embedded economic evaluation, to investigate the potential clinical effectiveness and cost-effectiveness of the Prevention of Delirium system of care, compared with standard care, among older patients admitted to hospital for emergency care. The primary objectives related to gathering information to design a definitive trial. Criteria for progression to a definitive trial were as follows: a minimum of six wards (75%) completing the Prevention of Delirium manual milestone checklist and an overall recruitment rate of at least 10% of the potential recruitment pool. Setting This study was set in NHS general hospitals. Participants In project 1, participants were staff, volunteers, and patient and carer representatives. In project 2, participants were staff, volunteers, patients and carers. In project 3, participants were older patients admitted to elderly care and orthopaedic trauma wards. Intervention The developed intervention (i.e. the Prevention of Delirium system of care). Main outcome measures For the feasibility study (project 3), the primary outcome measure was the Confusion Assessment Method. The secondary outcome measures were the Nottingham Extended Activities of Daily Living scale, the Clinical Anxiety Scale and the Geriatric Depression Scale Short Form. Results Project 1: understanding of delirium prevention was poor. Drawing on evidence, and working with ward teams, we developed the Prevention of Delirium system of care, which targeted 10 delirium risk factors. This multicomponent intervention incorporated systems and mechanisms to introduce and embed delirium prevention into routine ward practices. Project 2: five out of six wards implemented or partially implemented the Prevention of Delirium intervention. A prominent role for hospital volunteers was intended, but most wards were unable to recruit or sustain the numbers needed. We identified four conditions necessary to implement and deliver the Prevention of Delirium intervention: (1) commitment of senior nurse, (2) a named person to drive implementation forward, (3) dedicated time (1 day per week) of an experienced nurse to lead implementation and (4) adequate ward staffing levels. Overall, the intervention was acceptable to staff, volunteers, patients and carers, and did not increase nursing staff workload. In the light of these findings, the Prevention of Delirium system of care was modified for use in project 3. Project 3: 16 wards in eight hospitals (two wards per hospital) were recruited. Out of 4449 patients screened, 3274 (73.6%) were eligible and 713 were registered, resulting in a recruitment rate of 16.0%. Thirty-three (4.6%) participants withdrew. The screened and registered participants were similar, but some between-treatment group imbalances were noted among those registered to the trial. All eight wards allocated to the intervention group completed the Prevention of Delirium manual milestone checklist and delivered the Prevention of Delirium intervention (median time 18.6 weeks for implementation). Overall, fidelity to the intervention was assessed as being high in two wards, medium in five wards and low in one ward. Of the expected 5645 Confusion Assessment Method delirium assessments, 5065 (89.7%) were completed during the first 10 days of admission. The rates of return of the patient-reported questionnaire booklets were 98.0% at baseline, 81.8% at 30 days and 70.5% at 3 months. The return rate of the EuroQol-5 Dimensions questionnaire was 98.6% at baseline, 77.5% at 1 month and 65.3% at 3 months (94–98% fully completed). The completion rate of the resource use questionnaire was lower (48.7%). The number of people with new-onset delirium at 10 days was 24 (7.0%) in the Prevention of Delirium group and 33 (8.9%) in the control group. Multilevel logistic regression analysis showed that participants in the Prevention of Delirium group had non-significant lower odds of developing delirium (odds ratio 0.68, 95% confidence interval 0.37 to 1.26; p = 0.2225). The average cost of the Prevention of Delirium intervention was estimated as £10.98 per patient and the mean costs for the Prevention of Delirium and usual-care groups were £5332 and £4412, respectively, with negligible between-group differences in quality-adjusted life-years. There was conflicting evidence from the trial- and model-based analyses relating to the cost-effectiveness of the Prevention of Delirium intervention. Given this, and in view of issues with the data (e.g. high levels of missingness), the results from the economic evaluation are highly uncertain. The criteria for continuation to a future definitive randomised controlled trial were met. Such a trial would need to recruit 5200 patients in 26 hospital clusters (200 patients per cluster). Conclusions The Prevention of Delirium system of care was successfully developed, and a multicentre feasibility study showed that the intervention is capable of implementation and delivery in routine care, with acceptable intervention fidelity and preliminary estimate of...
, Alan Blighe, Robin Carpenter, , , Sally Gordon, , Liz Jones, Natalia Lago, , et al.
Programme Grants for Applied Research, Volume 9, pp 1-200;

Background An unplanned hospital admission of a nursing home resident distresses the person, their family and nursing home staff, and is costly to the NHS. Improving health care in care homes, including early detection of residents’ health changes, may reduce hospital admissions. Previously, we identified four conditions associated with avoidable hospital admissions. We noted promising ‘within-home’ complex interventions including care pathways, knowledge and skills enhancement, and implementation support. Objectives Develop a complex intervention with implementation support [the Better Health in Residents in Care Homes with Nursing (BHiRCH-NH)] to improve early detection, assessment and treatment for the four conditions. Determine its impact on hospital admissions, test study procedures and acceptability of the intervention and implementation support, and indicate if a definitive trial was warranted. Design A Carer Reference Panel advised on the intervention, implementation support and study documentation, and engaged in data analysis and interpretation. In workstream 1, we developed a complex intervention to reduce rates of hospitalisation from nursing homes using mixed methods, including a rapid research review, semistructured interviews and consensus workshops. The complex intervention comprised care pathways, approaches to enhance staff knowledge and skills, implementation support and clarity regarding the role of family carers. In workstream 2, we tested the complex intervention and implementation support via two work packages. In work package 1, we conducted a feasibility study of the intervention, implementation support and study procedures in two nursing homes and refined the complex intervention to comprise the Stop and Watch Early Warning Tool (S&W), condition-specific care pathways and a structured framework for nurses to communicate with primary care. The final implementation support included identifying two Practice Development Champions (PDCs) in each intervention home, and supporting them with a training workshop, practice development support group, monthly coaching calls, handbooks and web-based resources. In work package 2, we undertook a cluster randomised controlled trial to pilot test the complex intervention for acceptability and a preliminary estimate of effect. Setting Fourteen nursing homes allocated to intervention and implementation support (n = 7) or treatment as usual (n = 7). Participants We recruited sufficient numbers of nursing homes (n = 14), staff (n = 148), family carers (n = 95) and residents (n = 245). Two nursing homes withdrew prior to the intervention starting. Intervention This ran from February to July 2018. Data sources Individual-level data on nursing home residents, their family carers and staff; system-level data using nursing home records; and process-level data comprising how the intervention was implemented. Data were collected on recruitment rates, consent and the numbers of family carers who wished to be involved in the residents’ care. Completeness of outcome measures and data collection and the return rate of questionnaires were assessed. Results The pilot trial showed no effects on hospitalisations or secondary outcomes. No home implemented the intervention tools as expected. Most staff endorsed the importance of early detection, assessment and treatment. Many reported that they ‘were already doing it’, using an early-warning tool; a detailed nursing assessment; or the situation, background, assessment, recommendation communication protocol. Three homes never used the S&W and four never used care pathways. Only 16 S&W forms and eight care pathways were completed. Care records revealed little use of the intervention principles. PDCs from five of six intervention homes attended the training workshop, following which they had variable engagement with implementation support. Progression criteria regarding recruitment and data collection were met: 70% of homes were retained, the proportion of missing data was < 20% and 80% of individual-level data were collected. Necessary rates of data collection, documentation completion and return over the 6-month study period were achieved. However, intervention tools were not fully adopted, suggesting they would not be sustainable outside the trial. Few hospitalisations for the four conditions suggest it an unsuitable primary outcome measure. Key cost components were estimated. Limitations The study homes may already have had effective approaches to early detection, assessment and treatment for acute health changes; consistent with government policy emphasising the need for enhanced health care in homes. Alternatively, the implementation support may not have been sufficiently potent. Conclusion A definitive trial is feasible, but the intervention is unlikely to be effective. Participant recruitment, retention, data collection and engagement with family carers can guide subsequent studies, including service evaluation and quality improvement methodologies. Future work Intervention research should be conducted in homes which need to enhance early detection, assessment and treatment. Interventions to reduce avoidable hospital admissions may be beneficial in residential care homes, as they are not required to employ nurses. Trial registration Current Controlled Trials ISRCTN74109734 and ISRCTN86811077. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 2. See the NIHR Journals Library website for further project information.
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