An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

Background: Health services internationally are exploring the potential of telehealth to support the management of the growing number of people with long-term conditions (LTCs). Aim: To develop, implement and evaluate new care programmes for patients with LTCs, focusing on two common LTCs as exemplars: depression or high cardiovascular disease (CVD) risk. Methods Development: We synthesised quantitative and qualitative evidence on the effectiveness of telehealth for LTCs, conducted a qualitative study based on interviews with patients and staff and undertook a postal survey to explore which patients are interested in different forms of telehealth. Based on these studies we developed a conceptual model [TElehealth in CHronic disease (TECH) model] as a framework for the development and evaluation of the Healthlines Service for patients with LTCs. Implementation: The Healthlines Service consisted of regular telephone calls to participants from health information advisors, supporting them to make behaviour change and to use tailored online resources. Advisors sought to optimise participants’ medication and to improve adherence. Evaluation: The Healthlines Service was evaluated with linked pragmatic randomised controlled trials comparing the Healthlines Service plus usual care with usual care alone, with nested process and economic evaluations. Participants were adults with depression or raised CVD risk recruited from 43 general practices in three areas of England. The primary outcome was response to treatment and the secondary outcomes included anxiety (depression trial), individual risk factors (CVD risk trial), self-management skills, medication adherence, perceptions of support, access to health care and satisfaction with treatment. Trial results Depression trial: In total, 609 participants were randomised and the retention rate was 86%. Response to treatment [Patient Health Questionnaire 9-items (PHQ-9) reduction of ≥ 5 points and score of < 10 after 4 months] was higher in the intervention group (27%, 68/255) than in the control group (19%, 50/270) [odds ratio 1.7, 95% confidence interval (CI) 1.1 to 2.5; p = 0.02]. Anxiety also improved. Intervention participants reported better access to health support, greater satisfaction with treatment and small improvements in self-management, but not improved medication adherence. CVD risk trial: In total, 641 participants were randomised and the retention rate was 91%. Response to treatment (maintenance of/reduction in QRISK®2 score after 12 months) was higher in the intervention group (50%, 148/295) than in the control group (43%, 124/291), which does not exclude a null effect (odds ratio 1.3, 95% CI 1.0 to 1.9; p = 0.08). The intervention was associated with small improvements in blood pressure and weight, but not smoking or cholesterol. Intervention participants were more likely to adhere to medication, reported better access to health support and greater satisfaction with treatment, but few improvements in self-management. The Healthlines Service was likely to be cost-effective for CVD risk, particularly if the benefits are sustained, but not for depression. The intervention was implemented largely as planned, although initial delays and later disruption to delivery because of the closure of NHS Direct may have adversely affected participant engagement. Conclusion: The Healthlines Service, designed using an evidence-based conceptual model, provided modest health benefits and participants valued the better access to care and extra support provided. This service was cost-effective for CVD risk but not depression. These findings of small benefits at extra cost are consistent with previous pragmatic research on the implementation of comprehensive telehealth programmes for LTCs

Improving care for people with dementia: development and initial feasibility study for evaluation of life story work in dementia care

Background: Improving dementia care quality is an urgent priority nationally and internationally. Life story work (LSW) is an intervention that aims to improve individual outcomes and care for people with dementia and their carers. LSW gathers information and artefacts about the person, their history and interests, and produces a tangible output: the ‘life story’. Objective: To establish whether or not full evaluation of LSW was feasible. Design: Mixed-methods feasibility study. Methods: In-depth interviews and focus groups explored experiences of LSW and best practice with people with dementia, family members and dementia care staff. A systematic review explored best practice and theories of change for LSW. These stages helped to identify the outcomes and resources to explore in the feasibility study. A representative sample survey of health and social care dementia care providers in England established LSW practice in different settings. A survey of a self-selected sample of family members of people with dementia explored how LSW is experienced. Two small outcome studies (stepped-wedge study in six care homes and pre-test post-test study in inpatient specialist dementia care wards) explored the feasibility of full evaluation of LSW in these settings. Settings: Survey: generalist and specialist care homes; NHS dementia care settings; and community dementia services. Feasibility study: care homes and NHS inpatient dementia care wards. Participants: NHS and social care services, people with dementia, family carers, care home staff and NHS staff. Interventions: LSW. Main outcome measures: Spread of LSW and good practice, quality of life (QoL) for the person with dementia and carers, relationships between people with dementia and family carers, staff attitudes about dementia, staff burnout, resource use and costs. Review methods: Narrative review and synthesis, following Centre for Review and Dissemination guidelines. Results: Good practice in LSW is identifiable, as are theories of change about how it might affect given outcomes. Indicators of best practice were produced. LSW is spreading but practice and use vary between care settings and are not always in line with identified good practice. Two different models of LSW are evident; these are likely to be appropriate at different stages of the dementia journey. The feasibility study showed some positive changes in staff attitudes towards dementia and, for some people with dementia, improvements in QoL. These may be attributable to LSW but these potential benefits require full evaluation. The feasibility work established the likely costs of LSW and highlighted the challenges of future evaluation in care homes and inpatient dementia care settings. Limitations: There was insufficient evidence in the literature to allow estimation of outcome size. We did not carry out planned Markov chain modelling to inform decisions about carrying out future evaluation because of the dearth of outcome data in the literature; low levels of data return for people with dementia in the hospital settings; lack of detected effect for most people with dementia; and questions about implementation in the research settings. Conclusions: LSW is used across different health and social care settings in England, but in different ways, not all of which reflect ‘good practice’. This large, complex study identified a wide range of challenges for future research, but also the possibility that LSW may help to improve care staff attitudes towards dementia and QoL for some people with dementia. Future work: Full evaluation of LSW as an intervention to improve staff attitudes and care is feasible with researchers based in or very close to care settings to ensure high-quality data collection. Funding: The National Institute for Health Research Health Services and Delivery Research programme. Keywords

A randomised controlled trial to evaluate the impact of a human rights based approach to dementia care in inpatient ward and care home settings

BackgroundAlthough it is widely recognised that adopting a person-centred approach is beneficial in the care of people living with dementia, a gap remains between the rhetoric and the reality of quality care. Some widely adopted care practices can result in the personhood of this group being threatened and their human rights being undermined.ObjectivesTo evaluate the impact of applying a human rights based approach in dementia inpatient wards and care homes on the quality of care delivered and the well-being of the person living with dementia.DesignA cluster randomised design was employed to compare the impact of implementing a human rights based approach intervention (i.e. training, applying the ‘Getting It Right’ assessment tool and receiving booster sessions) at 10 intervention sites with 10 control sites.SettingEight NHS dementia inpatient wards and 12 care homes in the north-west of England.ParticipantsPeople living with dementia who were residing on dementia inpatient wards or in care homes, and staff working at these sites. The aim was to recruit 280 people living with dementia.InterventionsA sample of staff (an average of 8.9 per site) at each of the sites was trained in a human rights based approach to care, including the application of the ‘Getting It Right’ assessment tool. The tool was then introduced at the site and monthly booster sessions were delivered.Main outcome measuresThe primary outcome measure used in the research was the Quality of Life in Alzheimer’s Disease scale to assess the subjective well-being of the person with dementia. Secondary outcome measures included measures of the quality of care provided (dementia care mapping) and direct measures of the effectiveness of the training in increasing knowledge of and attitudes towards human rights. The study also included an economic evaluation utilising the EuroQol-5 Dimensions, three-level version, and the Adult Social Care Outcomes Toolkit measure.ResultsThe study recruited 439 people living with dementia: 213 to the intervention arm and 226 to the control arm. Primary outcome data were analysed using a linear mixed model. There were no significant differences found in the reported quality of life of residents between the control and intervention groups after the intervention [F(1,16.51) = 3.63;p = 0.074]. The mean difference between the groups was 1.48 (95% confidence interval –7.86 to 10.82).ConclusionsDespite the fact that the training increased staff knowledge of and positive attitudes towards human rights, and although there were some changes in staff decision-making strategies in clinical situations, there was no change in the quality of care provided or in the reported well-being of people living with dementia in these settings. This led to questions about the efficacy of training in bringing about cultural change and improving care practices.LimitationsThere was limited uptake of the training and booster sessions that were integral to the intervention.Future workFuture work could usefully focus on understanding the difficulty in translating change in attitude and knowledge into behaviour.Trial registrationCurrent Controlled Trials ISRCTN94553028.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 6, No. 13. See the NIHR Journals Library website for further project information.</jats:sec

Evidence for models of diagnostic service provision in the community: literature mapping exercise and focused rapid reviews

Background Current NHS policy favours the expansion of diagnostic testing services in community and primary care settings. Objectives Our objectives were to identify current models of community diagnostic services in the UK and internationally and to assess the evidence for quality, safety and clinical effectiveness of such services. We were also interested in whether or not there is any evidence to support a broader range of diagnostic tests being provided in the community. Review methods We performed an initial broad literature mapping exercise to assess the quantity and nature of the published research evidence. The results were used to inform selection of three areas for investigation in more detail. We chose to perform focused reviews on logistics of diagnostic modalities in primary care (because the relevant issues differ widely between different types of test); diagnostic ultrasound (a key diagnostic technology affected by developments in equipment); and a diagnostic pathway (assessment of breathlessness) typically delivered wholly or partly in primary care/community settings. Databases and other sources searched, and search dates, were decided individually for each review. Quantitative and qualitative systematic reviews and primary studies of any design were eligible for inclusion. Results We identified seven main models of service that are delivered in primary care/community settings and in most cases with the possible involvement of community/primary care staff. Not all of these models are relevant to all types of diagnostic test. Overall, the evidence base for community- and primary care-based diagnostic services was limited, with very few controlled studies comparing different models of service. We found evidence from different settings that these services can reduce referrals to secondary care and allow more patients to be managed in primary care, but the quality of the research was generally poor. Evidence on the quality (including diagnostic accuracy and appropriateness of test ordering) and safety of such services was mixed. Conclusions In the absence of clear evidence of superior clinical effectiveness and cost-effectiveness, the expansion of community-based services appears to be driven by other factors. These include policies to encourage moving services out of hospitals; the promise of reduced waiting times for diagnosis; the availability of a wider range of suitable tests and/or cheaper, more user-friendly equipment; and the ability of commercial providers to bid for NHS contracts. However, service development also faces a number of barriers, including issues related to staffing, training, governance and quality control. Limitations We have not attempted to cover all types of diagnostic technology in equal depth. Time and staff resources constrained our ability to carry out review processes in duplicate. Research in this field is limited by the difficulty of obtaining, from publicly available sources, up-to-date information about what models of service are commissioned, where and from which providers. Future work There is a need for research to compare the outcomes of different service models using robust study designs. Comparisons of ‘true’ community-based services with secondary care-based open-access services and rapid access clinics would be particularly valuable. There are specific needs for economic evaluations and for studies that incorporate effects on the wider health system. There appears to be no easy way of identifying what services are being commissioned from whom and keeping up with local evaluations of new services, suggesting a need to improve the availability of information in this area. Funding The National Institute for Health Research Health Services and Delivery Research programme

Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic

This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Background: Reconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence – with regard to ‘early neurosurgery’ in this cohort – which we sought to address. Methods: Pilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of  0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury. Conclusions: Current NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating ‘early neurosurgery through bypass’ and address the challenge of reliable TBI diagnosis at the scene of injury. Trial registration: Current Controlled Trials ISRCTN68087745. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 1. See the NIHR Journals Library website for further project information

The 'Choice and Autonomy Framework' : implications for occupational therapy practice

Introduction This paper presents findings from a PhD study exploring autonomy of adults with physical disability. The plethora of descriptions of autonomy in psychological, occupational therapy and rehabilitation literature (e.g. Ryan and Deci 2000, Rogers 1982, Cardol et al 2002) detracts from the centrality of autonomy and results in difficulty incorporating it into occupational therapy practice. This paper presents a framework providing an integrated, clinically useful approach to autonomy. Methods Sixteen people were recruited, based on age, gender, impairment and living circumstances (community/residential settings). All have significant physical disability, use a wheelchair and require personal assistance for some/all self-care activities. Qualitative methods were used for data collection, including life-history narrative, diary information and extensive interview. An integrated method of analysis was used, including content analysis and bracketing. Results The ‘Choice and Autonomy Framework’ consists of five strands, including: • the meaning of autonomy • whether or not autonomy is a goal or value • the experience of autonomy • personality factors that impact autonomy • environmental features that enhance or negate autonomy. This paper will describe each strand, as derived from the research. The results suggest that, contrary to common wisdom (Hmel and Pincus 2002), autonomy is not necessarily a universal goal for people with physical disability; an understanding of the person’s own perspective will enhance person-centred practice and enable therapists to further recognise individuality of clients. It will argue that the concept of autonomy needs to be further understood and incorporated into occupational therapy practice