A Cost Evaluation of COVID-19 Remote Home Monitoring Services in England.

BACKGROUND: Remote home monitoring services emerged as critical components of health care delivery from NHS England during the COVID-19 pandemic, aiming to provide timely interventions and reduce health care system burden. Two types of service were offered: referral by community health services to home-based care to ensure the right people were admitted to the hospital at the right time (called COVID Oximetry@home, CO@h); and referral by hospital to support patients' transition from hospital to home (called COVID-19 Virtual Ward, CVW). The information collected for the oxygen levels and other symptoms was provided via digital means (technology-enabled) or over the phone (analogue-only submission mode). This study aimed to evaluate the costs of implementing remote home monitoring for COVID-19 patients across 26 sites in England during wave 2 of the pandemic. Understanding the operational and financial implications of these services from the NHS perspective is essential for effective resource allocation and service planning. METHODS: We used a bottom-up costing approach at the intervention level to describe the costs of setting up and running the services. Twenty-six implementation sites reported the numbers of patients and staff involved in the service and other resources used. Descriptive statistics and multivariable regression analysis were used to assess cost variations and quantify the relationship between the number of users and costs while adjusting for other service characteristics. RESULTS: The mean cost per patient monitored was lower in the CO@h service compared with the CVW service (£527 vs £599). The mean cost per patient was lower for implementation sites using technology-enabled and analogue data submission modes compared with implementation sites using analogue-only modes for both CO@h (£515 vs £561) and CVW (£584 vs £612) services. The number of patients enrolled in the services and the service type significantly affected the mean cost per patient. CONCLUSIONS: Our analysis provides a framework for evaluating the costs of similar services in the future and shows that the implementation of these services benefit from the employment of tech-enabled data submission modes.

Recruitment to a trial of antipsychotic reduction: impact of an acceptability study.

OBJECTIVES: Pre-trial acceptability studies may boost recruitment, especially in trials comparing distinctly different interventions. We evaluated the impact of an acceptability study on recruitment to a randomised trial of antipsychotic reduction versus maintenance treatment and explored demographic and clinical predictors of subsequent enrolment. METHODS: Participants with a diagnosis of a schizophrenia spectrum disorder who were taking antipsychotic medication were interviewed about their views of taking part in a future trial. RESULTS: In a sample of 210 participants, 151 (71.9%) expressed an interest in taking part in the future trial, 16 (7.6%) said they might be interested, and 43 (20.5%) said they were not. Altruistic reasons were most commonly given for wanting to take part, and concern about randomisation for not wanting to. Ultimately 57 people enrolled in the trial (27.1% of the original sample). Eighty-five people who initially expressed an interest did not enrol due to declining or not being eligible (for clinical reasons). Women and people from a white ethnic background were more likely to enrol in the trial, but no illness or treatment-related characteristics were associated with enrolment. CONCLUSION: An acceptability study can be a useful tool for recruitment to challenging trials, but it may over-estimate recruitment.

Undertaking rapid evaluations during the COVID-19 pandemic: Lessons from evaluating COVID-19 remote home monitoring services in England.

Introduction: Rapid evaluations can offer evidence on innovations in health and social care that can be used to inform fast-moving policy and practise, and support their scale-up according to previous research. However, there are few comprehensive accounts of how to plan and conduct large-scale rapid evaluations, ensure scientific rigour, and achieve stakeholder engagement within compressed timeframes. Methods: Using a case study of a national mixed-methods rapid evaluation of COVID-19 remote home monitoring services in England, conducted during the COVID-19 pandemic, this manuscript examines the process of conducting a large-scale rapid evaluation from design to dissemination and impact, and reflects on the key lessons for conducting future large-scale rapid evaluations. In this manuscript, we describe each stage of the rapid evaluation: convening the team (study team and external collaborators), design and planning (scoping, designing protocols, study set up), data collection and analysis, and dissemination. Results: We reflect on why certain decisions were made and highlight facilitators and challenges. The manuscript concludes with 12 key lessons for conducting large-scale mixed-methods rapid evaluations of healthcare services. We propose that rapid study teams need to: (1) find ways of quickly building trust with external stakeholders, including evidence-users; (2) consider the needs of the rapid evaluation and resources needed; (3) use scoping to ensure the study is highly focused; (4) carefully consider what cannot be completed within a designated timeframe; (5) use structured processes to ensure consistency and rigour; (6) be flexible and responsive to changing needs and circumstances; (7) consider the risks associated with new data collection approaches of quantitative data (and their usability); (8) consider whether it is possible to use aggregated quantitative data, and what that would mean when presenting results, (9) consider using structured processes & layered analysis approaches to rapidly synthesise qualitative findings, (10) consider the balance between speed and the size and skills of the team, (11) ensure all team members know roles and responsibilities and can communicate quickly and clearly; and (12) consider how best to share findings, in discussion with evidence-users, for rapid understanding and use. Conclusion: These 12 lessons can be used to inform the development and conduct of future rapid evaluations in a range of contexts and settings.

Patients' experiences of, and engagement with, remote home monitoring services for COVID-19 patients: A rapid mixed-methods study.

INTRODUCTION: Remote home monitoring models were implemented during the COVID-19 pandemic to shorten hospital length of stay, reduce unnecessary hospital admission, readmission and infection and appropriately escalate care. Within these models, patients are asked to take and record readings and escalate care if advised. There is limited evidence on how patients and carers experience these services. This study aimed to evaluate patient experiences of, and engagement with, remote home monitoring models for COVID-19. METHODS: A rapid mixed-methods study was carried out in England (conducted from March to June 2021). We remotely conducted a cross-sectional survey and semi-structured interviews with patients and carers. Interview findings were summarized using rapid assessment procedures sheets and data were grouped into themes (using thematic analysis). Survey data were analysed using descriptive statistics. RESULTS: We received 1069 surveys (18% response rate) and conducted interviews with patients (n = 59) or their carers (n = 3). 'Care' relied on support from staff members and family/friends. Patients and carers reported positive experiences and felt that the service and human contact reassured them and was easy to engage with. Yet, some patients and carers identified problems with engagement (e.g., hesitancy to self-escalate care). Engagement was influenced by patient factors such as health and knowledge, support from family/friends and staff, availability and ease of use of informational and material resources (e.g., equipment) and service factors. CONCLUSION: Remote home monitoring models place responsibility on patients to self-manage symptoms in partnership with staff; yet, many patients required support and preferred human contact (especially for identifying problems). Caring burden and experiences of those living alone and barriers to engagement should be considered when designing and implementing remote home monitoring services. PATIENT OR PUBLIC CONTRIBUTION: The study team met with service users and public members of the evaluation teams throughout the project in a series of workshops. Workshops informed study design, data collection tools and data interpretation and were conducted to also discuss study dissemination. Public patient involvement (PPI) members helped to pilot patient surveys and interview guides with the research team. Some members of the public also piloted the patient survey. Members of the PPI group were given the opportunity to comment on the manuscript, and the manuscript was amended accordingly.

The impact of post-hospital remote monitoring of COVID-19 patients using pulse oximetry: A national observational study using hospital activity data.

Background: There was a national roll out of 'COVID Virtual Wards' (CVW) during England's second COVID-19 wave (Autumn 2020 - Spring 2021). These services used remote pulse oximetry monitoring for COVID-19 patients following discharge from hospital. A key aim was to enable rapid detection of patient deterioration. It was anticipated that the services would support early discharge, reducing pressure on beds. This study is an evaluation of the impact of the CVW services on hospital activity. Methods: Using retrospective patient-level hospital admissions data, we built multivariate models to analyze the relationship between the implementation of CVW services and hospital activity outcomes: length of COVID-19 related stays and subsequent COVID-19 readmissions within 28 days. We used data from more than 98% of recorded COVID-19 hospital stays in England, where the patient was discharged alive between mid-August 2020 and late February 2021. Findings: We found a longer length of stay for COVID-19 patients discharged from hospitals where a CVW was available, when compared to patients discharged from hospitals where there was no CVW (adjusted IRR 1·05, 95% CI 1·01 to 1·09). We found no evidence of a relationship between the availability of CVW and subsequent rates of readmission for COVID-19 (adjusted OR 0.97, 95% CI 0.91 to 1·03). Interpretation: We found no evidence of early discharges or changes in readmissions associated with the roll out of COVID Virtual Wards across England. Our analysis made pragmatic use of national-scale hospital data, but it is possible that a lack of specific data (for example, on which patients were enrolled and on potentially important confounders) may have meant that true impacts, especially at a local level, were not ultimately discernible. It is important that future research is able to make use of better quality - preferably linked - data, from multiple sites. Funding: This is independent research funded by the National Institute for Health Research, Health Services & Delivery Research program (RSET Project no. 16/138/17; BRACE Project no. 16/138/31) and NHSE&I. NJF is an NIHR Senior Investigator.

A qualitative exploration of family members' perspectives on reducing and discontinuing antipsychotic medication.

BACKGROUND: Antipsychotics are routinely prescribed to people diagnosed with schizophrenia or psychosis on a long-term basis. Considerable literature explores service users' opinions and experiences of antipsychotics, but studies investigating family members' views are lacking. AIMS: To explore family members' perspectives on antipsychotics, particularly their views on long-term use, reduction and discontinuation of antipsychotics. METHODS: Semi-structured interviews were conducted with 11 family members of people experiencing psychosis. Participants were recruited through community support groups and mental health teams. Interviews were analysed thematically. RESULTS: The majority of family members valued antipsychotic medication primarily in supporting what they saw as a fragile stability in the person they cared for. Their views of medication were ambivalent, combining concerns about adverse effects with a belief in the importance of medication due to fears of relapse. They described a need for constant vigilance in relation to medication to ensure it was taken consistently, and often found changes, particularly reduction in medication difficult to contemplate. CONCLUSIONS: Findings highlight that family members' attitudes to medication sometimes conflict with those of the people they care for, impacting on their health and the caring relationship. Family members may need more support and could be usefully involved in medication decision-making.

An analysis of views about supported reduction or discontinuation of antipsychotic treatment among people with schizophrenia and other psychotic disorders.

BACKGROUND: Antipsychotic medication can reduce psychotic symptoms and risk of relapse in people with schizophrenia and related disorders, but it is not always effective and adverse effects can be significant. We know little of patients' views about continuing or discontinuing antipsychotic treatment. AIMS: To explore the views of people with schizophrenia and other psychotic disorders about continuing their antipsychotic medication or attempting to reduce or discontinue this medication with clinical support. METHODS: We collected quantitative and qualitative data by conducting semi-structured interviews in London, UK. Factors predicting a desire to discontinue medication were explored. Content analysis of qualitative data was undertaken. RESULTS: We interviewed 269 participants. 33% (95% CI, 27 to 39%) were content with taking long-term antipsychotic medication. Others reported they took it reluctantly (19%), accepted it on a temporary basis (24%) or actively disliked it (18%). 31% (95% CI, 25 to 37%) said they would like to try to stop medication with professional support, and 45% (95% CI, 39 to 51%) wanted the opportunity to reduce medication. People who wanted to discontinue had more negative attitudes towards the medication but were otherwise similar to other participants. Wanting to stop or reduce medication was motivated mainly by adverse effects and health concerns. Professional support was identified as potentially helpful to achieve reduction. CONCLUSIONS: This large study reveals that patients are commonly unhappy about the idea of taking antipsychotics on a continuing or life-long basis. Professional support for people who want to try to reduce or stop medication is valued.

The impact of remote home monitoring of people with COVID-19 using pulse oximetry: A national population and observational study.

BACKGROUND: Remote home monitoring of people testing positive for COVID-19 using pulse oximetry was implemented across England during the Winter of 2020/21 to identify falling blood oxygen saturation levels at an early stage. This was hypothesised to enable earlier hospital admission, reduce the need for intensive care and improve survival. This study is an evaluation of the clinical effectiveness of the pre-hospital monitoring programme, COVID oximetry @home (CO@h). METHODS: The setting was all Clinical Commissioning Group (CCG) areas in England where there were complete data on the number of people enrolled onto the programme between 2nd November 2020 and 21st February 2021. We analysed relationships at a geographical area level between the extent to which people aged 65 or over were enrolled onto the programme and outcomes over the period between November 2020 to February 2021. FINDINGS: For every 10% increase in coverage of the programme, mortality was reduced by 2% (95% confidence interval:4% reduction to 1% increase), admissions increased by 3% (-1% to 7%), in-hospital mortality fell by 3% (-8% to 3%) and lengths of stay increased by 1·8% (-1·2% to 4·9%). None of these results are statistically significant, although the confidence interval indicates that any adverse effect on mortality would be small, but a mortality reduction of up to 4% may have resulted from the programme. INTERPRETATION: There are several possible explanations for our findings. One is that CO@h did not have the hypothesised impact. Another is that the low rates of enrolment and incomplete data in many areas reduced the chances of detecting any impact that may have existed. Also, CO@h has been implemented in many different ways across the country and these may have had varying levels of effect. FUNDING: This is independent research funded by the National Institute for Health Research, Health Services & Delivery Research programme (RSET Project no. 16/138/17; BRACE Project no. 16/138/31) and NHSEI. NJF is an NIHR Senior Investigator.

A systematic review of social functioning outcome measures in schizophrenia with a focus on suitability for intervention research.

Social functioning is an important part of recovery and a key treatment target in clinical research in schizophrenia. Evaluating and comparing interventions is challenged by the choice of many measures which focus on different aspects of functioning, with little to guide selection. This results in difficulties comparing outcomes of treatment where studies have used different measures. To improve the measurement of social functioning in intervention research, we aimed to provide practical information on suitability of measures. We conducted a systematic review of measures developed or psychometrically evaluated since 2007, and assessed and discussed the structure, content, quality, and the use of the measures in intervention research. Thirty-two measures of social functioning and 22 validation papers were identified. Measures included structured questionnaires, semi-structured interviews, and assessment of performance on specific tasks. The content of measures was organised into eight categories, which are in order of frequency with which they were covered by measures: activities of daily living, productive activity, relationships, leisure activities, cognition, anti-social behaviour, psychosis symptoms and self-esteem and empowerment. In terms of quality, most measures were rated as moderate, with the Personal and Social Performance Scale gaining the highest rating. However, there was little data on responsiveness of measures, or how they compare to objective or 'real-world' indicators of functioning. The Social Functioning Scale and Personal and Social Performance Scale have been most frequently used in intervention studies to date. Future research should aim to provide further data on psychometric properties relevant to intervention research.

Definitions of relapse in trials comparing antipsychotic maintenance with discontinuation or reduction for schizophrenia spectrum disorders: A systematic review.

INTRODUCTION: Avoidance of relapse is the main aim of long-term antipsychotic treatment in schizophrenia, yet how 'relapse' is defined in trials is not well-known. METHODS: We conducted a systematic review of definitions of relapse in trials of continuous antipsychotic treatment compared with discontinuation, intermittent treatment or dose reduction for people with schizophrenia spectrum disorders. Trials were identified from previous Cochrane reviews and a new search. The quality of relapse definitions was rated in terms of reliability and clinical relevance and associations between quality of definitions and trial characteristics and outcome were explored. RESULTS: We identified 82 reports of 81 trials which employed 54 different definitions of relapse. There were 33 definitions in the 35 trials published since 1990, with recent trials employing complex definitions often involving alternative criteria. Only ten primary definitions of relapse required the presence of psychotic symptoms in all cases, and only three specified this in combination with a measure of overall severity or functional decline. Only two definitions specified a duration longer than two days. Relapse definitions were rated as showing good reliability in 37 trials, but only seven showed good clinical relevance. Six trials with definitions that were both reliable and clinically relevant were slightly longer, but did not differ from remaining trials in other characteristics or overall or relative risk of relapse. CONCLUSIONS: Antipsychotic trials define relapse in numerous different ways, and few definitions consistently reflect suggested indications of a clinically significant relapse.

Experiences of taking neuroleptic medication and impacts on symptoms, sense of self and agency: a systematic review and thematic synthesis of qualitative data.

PURPOSE: Neuroleptic (antipsychotic) drugs reduce psychotic symptoms, but how they achieve these effects and how the drugs' effects are experienced by people who take them are less well understood. The present study describes a synthesis of qualitative data about mental and behavioural alterations associated with taking neuroleptics and how these interact with symptoms of psychosis and people's sense of self and agency. METHODS: Nine databases were searched to identify qualitative literature concerning experiences of taking neuroleptic medication. A thematic synthesis was conducted. RESULTS: Neuroleptics were commonly experienced as producing a distinctive state of lethargy, cognitive slowing, emotional blunting and reduced motivation, which impaired functioning but also had beneficial effects on symptoms of psychosis and some other symptoms (e.g. insomnia). For some people, symptom reduction helped restore a sense of normality and autonomy, but others experienced a loss of important aspects of their personality. Across studies, many people adopted a passive stance towards long-term medication, expressing a sense of resignation, endurance or loss of autonomy. CONCLUSIONS: Neuroleptic drugs modify cognition, emotions and motivation. These effects may be associated with reducing the intensity and impact of symptoms, but also affect people's sense of self and agency. Understanding how the effects of neuroleptics are experienced by those who take them is important in developing a more collaborative approach to drug treatment in psychosis and schizophrenia.

Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction).

INTRODUCTION: Antipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes. METHODS AND ANALYSIS: This is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022. ETHICS AND DISSEMINATION: Ethical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public. TRIAL REGISTRATION NUMBER: ISRCTN90298520. EudraCT: 2016-000709-36. Pre-results.

Self-efficacy and health-related quality of life in family carers of people with dementia: a systematic review.

OBJECTIVES: This review aims to explore the role of self-efficacy (SE) in the health-related quality of life (QoL) of family carers of people with dementia. METHODS: A systematic review of literature identified a range of qualitative and quantitative studies. Search terms related to caring, SE, and dementia. Narrative synthesis was adopted to synthesise the findings. RESULTS: Twenty-two studies met the full inclusion criteria, these included 17 quantitative, four qualitative, and one mixed-method study. A model describing the role of task/domain-specific SE beliefs in family carer health-related QoL was constructed. This model was informed by review findings and discussed in the context of existing conceptual models of carer adaptation and empirical research. Review findings offer support for the application of the SE theory to caring and for the two-factor view of carer appraisals and well-being. Findings do not support the independence of the negative and positive pathways. The review was valuable in highlighting methodological challenges confronting this area of research, particularly the conceptualisation and measurement issues surrounding both SE and health-related QoL. CONCLUSIONS: The model might have theoretical implications in guiding future research and advancing theoretical models of caring. It might also have clinical implications in facilitating the development of carer support services aimed at improving SE. The review highlights the need for future research, particularly longitudinal research, and further exploration of domain/task-specific SE beliefs, the influence of carer characteristics, and other mediating/moderating variables.