Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Patient and staff experiences of using technology-enabled and analogue models of remote home monitoring for COVID-19 in England: A mixed-method evaluation.

OBJECTIVE: To evaluate patient and staff experiences of using technology-enabled ('tech-enabled') and analogue remote home monitoring models for COVID-19, implemented in England during the pandemic. METHODS: Twenty-eight sites were selected for diversity in a range of criteria (e.g. pre-hospital or early discharge service, mode of patient data submission). Between February and May 2021, we conducted quantitative surveys with patients, carers and staff delivering the service, and interviewed patients, carers, and staff from 17 of the 28 services. Quantitative data were analysed using descriptive statistics and both univariate and multivariate analyses. Qualitative data were interpreted using thematic analysis. RESULTS: Twenty-one sites adopted mixed models whereby patients could submit their symptoms using either tech-enabled (app, weblink, or automated phone calls) or analogue (phone calls with a health professional) options; seven sites offered analogue-only data submission (phone calls or face-to-face visits with a health professional). Sixty-two patients and carers were interviewed, and 1069 survey responses were received (18 % response rate). Fifty-eight staff were interviewed, and 292 survey responses were received (39 % response rate). Patients who used tech-enabled modes tended to be younger (p = 0.005), have a higher level of education (p = 0.011), and more likely to identify as White British (p = 0.043). Most patients found relaying symptoms easy, regardless of modality, though many received assistance from family or friends. Staff considered the adoption of mixed delivery models beneficial, enabling them to manage large patient numbers and contact patients for further assessment as needed; however, they suggested improvements to the functionality of systems to better fit clinical and operational needs. Human contact was important in all remote home monitoring options. CONCLUSIONS: Organisations implementing tech-enabled remote home monitoring at scale should consider adopting mixed models which can accommodate patients with different needs; focus on the usability and interoperability of tech-enabled platforms; and encourage digital inclusivity for patients.

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.

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.

Individual, healthcare professional and system-level barriers and facilitators to initiation and adherence to injectable therapies for type 2 diabetes: A systematic review and meta-ethnography.

AIMS: To review and synthesise the contemporary qualitative evidence, relating to the individual, healthcare professional and system-level barriers and facilitators to injectable therapies in people with type 2 diabetes, and evaluate (using an intersectional approach to explore the diverse perspectives of different identities) whether views have changed with treatment and guideline advancements. METHODS: A meta-ethnography approach used. Eight databases searched from the years 2006 (GLP-1 analogues introduced) to February 2021. Study selection (using a pre-defined inclusion criteria), quality appraisal and data extraction, conducted independently by two reviewers. RESULTS: Screened 7143 abstracts, assessed 93 full-text papers for eligibility and included 42 studies-using data from 818 individuals with type 2 diabetes and 160 healthcare professionals. Studies covered a diverse range of views from healthcare professionals and individuals, including those relating to older adults and people from ethnic migrant backgrounds, and 10 studies rated moderate to strong research value. Key themes abstracted: barriers (physical/psychological/social) and facilitators (motivation/capability/opportunity). CONCLUSIONS: The first synthesis of contemporary qualitative data to adopt an intersectionality approach and explore diverse views relating to barriers and facilitators that influence engagement with injectable treatments for type 2 diabetes. A model is presented to help patients, health practitioners and policy makers identify barriers and facilitators and understand the complex interplay of physical, psychological and social factors involved when prescribing injectable therapies. Despite advances in injectable treatments and guidelines, findings highlight the many barriers that still exist and show how strongly held culturally-specific health beliefs of people from diverse socio-economic and ethnic backgrounds can become substantial obstacles to treatment.

Remote home monitoring (virtual wards) for confirmed or suspected COVID-19 patients: a rapid systematic review.

BACKGROUND: the aim of this review was to analyze the implementation and impact of remote home monitoring models (virtual wards) for confirmed or suspected COVID-19 patients, identifying their main components, processes of implementation, target patient populations, impact on outcomes, costs and lessons learnt. METHODS: we carried out a rapid systematic review on models led by primary and secondary care across seven countries (US, Australia, Canada, The Netherlands, Ireland, China, UK). The main outcomes included in the review were: impact of remote home monitoring on virtual length of stay, escalation, emergency department attendance/reattendance, admission/readmission and mortality. The search was updated on February 2021. We used the PRISMA statement and the review was registered on PROSPERO (CRD: 42020202888). FINDINGS: the review included 27 articles. The aim of the models was to maintain patients safe in the appropriate setting. Most models were led by secondary care and confirmation of COVID-19 was not required (in most cases). Monitoring was carried via online platforms, paper-based systems with telephone calls or (less frequently) through wearable sensors. Models based on phone calls were considered more inclusive. Patient/career training was identified as a determining factor of success. We could not reach substantive conclusions regarding patient safety and the identification of early deterioration due to lack of standardized reporting and missing data. Economic analysis was not reported for most of the models and did not go beyond reporting resources used and the amount spent per patient monitored. INTERPRETATION: future research should focus on staff and patient experiences of care and inequalities in patients' access to care. Attention needs to be paid to the cost-effectiveness of the models and their sustainability, evaluation of their impact on patient outcomes by using comparators, and the use of risk-stratification tools.

The implementation of remote home monitoring models during the COVID-19 pandemic in England.

BACKGROUND: There is a paucity of evidence for the implementation of remote home monitoring for COVID-19 infection. The aims of this study were to identify the key characteristics of remote home monitoring models for COVID-19 infection, explore the experiences of staff implementing these models, understand the use of data for monitoring progress against outcomes, and document variability in staffing and resource allocation. METHODS: This was a multi-site mixed methods study conducted between July and August 2020 that combined qualitative and quantitative approaches to analyse the implementation and impact of remote home monitoring models developed during the first wave of the COVID-19 pandemic in England. The study combined interviews (n = 22) with staff delivering these models across eight sites in England with the collection and analysis of data on staffing models and resource allocation. FINDINGS: The models varied in relation to the healthcare settings and mechanisms used for patient triage, monitoring and escalation. Implementation was embedded in existing staff workloads and budgets. Good communication within clinical teams, culturally-appropriate information for patients/carers and the combination of multiple approaches for patient monitoring (app and paper-based) were considered facilitators in implementation. The mean cost per monitored patient varied from £400 to £553, depending on the model. INTERPRETATION: It is necessary to provide the means for evaluating the effectiveness of these models, for example, by establishing comparator data. Future research should also focus on the sustainability of the models and patient experience (considering the extent to which some of the models exacerbate existing inequalities in access to care).

Risk work or resilience work? A qualitative study with community health workers negotiating the tensions between biomedical and community-based forms of health promotion in the United Kingdom.

Emplaced health promotion interventions, delivered by community health workers are increasingly being used internationally. However, the application of epidemiological risk knowledge to individuals within such communities is not straightforward and creates tensions for community health workers who are part of the communities that they are serving. Situated qualitative interview data were co-produced with community health workers employed in a superdiverse, deprived, post-industrial region of the United Kingdom, using photo-voice methods, to develop an account of how they made sense of the challenges of their work. The analysis draws on and develops theories of risk work and resilience work, which draw on practice theory. The key findings were that, first, being a critical insider enabled community health workers to make sense of the diverse constraints on health and lifestyles within their community. Second, they understood their own public health role as limited by operating within this context, so they articulated their occupational identity as focused on supporting clients to make small but sustainable changes to their own and their families' lifestyles. Third, the uncertainties of translating population based risk information to individual clients were (at least partially) resolved at an embodied level, with the community health workers identifying as accessible and trusted role models for the value of changed lifestyles. The article is important for policy and practice as it provides a critique of a rapidly evolving new mode of delivery of public health services, and insights on the development of this new public health workforce.

Self management of patients with mild COPD in primary care: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of telephone health coaching delivered by a nurse to support self management in a primary care population with mild symptoms of chronic obstructive pulmonary disease (COPD). DESIGN: Multicentre randomised controlled trial. SETTING: 71 general practices in four areas of England. PARTICIPANTS: 577 patients with Medical Research Council dyspnoea scale scores of 1 or 2, recruited from primary care COPD registers with spirometry confirmed diagnosis. Patients were randomised to telephone health coaching (n=289) or usual care (n=288). INTERVENTIONS: Telephone health coaching intervention delivered by nurses, underpinned by Social Cognitive Theory. The coaching promoted accessing smoking cessation services, increasing physical activity, medication management, and action planning (4 sessions over 11 weeks; postal information at weeks 16 and 24). The nurses received two days of training. The usual care group received a leaflet about COPD. MAIN OUTCOME MEASURES: The primary outcome was health related quality of life at 12 months using the short version of the St George's Respiratory Questionnaire (SGRQ-C). RESULTS: The intervention was delivered with good fidelity: 86% of scheduled calls were delivered; 75% of patients received all four calls. 92% of patients were followed-up at six months and 89% at 12 months. There was no difference in SGRQ-C total score at 12 months (mean difference -1.3, 95% confidence interval -3.6 to 0.9, P=0.23). Compared with patients in the usual care group, at six months follow-up, the intervention group reported greater physical activity, more had received a care plan (44% v 30%), rescue packs of antibiotics (37% v 29%), and inhaler use technique check (68% v 55%). CONCLUSIONS: A new telephone health coaching intervention to promote behaviour change in primary care patients with mild symptoms of dyspnoea did lead to changes in self management activities, but did not improve health related quality of life. TRIAL REGISTRATION: Current controlled trials ISRCTN 06710391.

Evaluation of a text supported weight maintenance programme 'Lighten Up Plus' following a weight reduction programme: randomised controlled trial.

BACKGROUND: Many overweight people find it difficult to maintain weight loss after attending a weight reduction programme. Self-weighing and telephone support are known to be useful methods for self-monitoring for weight loss. We examined the effectiveness of an SMS-text messaging based weight maintenance programme to encourage regular self-weighing in adults who had completed a 12 week commercial weight loss programme. METHODS: Randomised controlled trial of 380 obese or overweight men and women. The intervention group (N = 190) received a single maintenance support phone call and SMS-text based weight maintenance messages over 12 weeks to encourage regular self-weighing after completing their weight loss programme. The primary outcome was change in weight at 9 months follow up. RESULTS: Our sample (N = 380) had a mean age of 47.4 years (SD 13.4), mean baseline weight and BMI of 93.1 kg (16.1) and 34.4 kg/m(2) (5.0) respectively, as well as majority female (87.3%) and White British (80.0%). Using intention to treat analysis both groups regained weight at 9 months follow up; the intervention group regained an average of 1.36 kg while the control group regained 1.81 kg. Adjusting for covariates resulted in a mean difference of 0.45 kg (95% CI -0.78, 1.67) favouring the intervention group at 9 month follow up. CONCLUSIONS: We found no evidence that an SMS based weight maintenance intervention encouraging adults to weigh themselves weekly prevented weight regain at 3 or 9 months after completing a commercial weight loss programme. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47845106 .

Long-term conditions, self-management and systems of support: an exploration of health beliefs and practices within the Sikh community, Birmingham, UK.

OBJECTIVE: The global prevalence of non-communicable diseases (NCDs), such as diabetes mellitus and coronary heart disease, continues to rise. Internationally, people of South Asian origin (i.e. by birth or heritage) are much more likely to develop and live with NCDs compared to the general population. The South Asian diaspora population is highly heterogeneous, varying by socioeconomic status, migration history, religion and ethnicity. This article reports the findings of a study to explore the types of support accessed by Punjabi Sikhs living in Birmingham and the Black Country, UK, who were living with NCDs. DESIGN: The study sought to develop a greater understanding of past experiences of accessing support and the importance of relationships in the mobilisation of resources for self-management. It was nested within a larger programme of research which explored attitudes to prevention of chronic diseases in local communities in the region. Seventeen Punjabi Sikh men and women were recruited through purposive sampling. Narrative interviews were conducted and analysed by the research team. Sociological theories on systems of support and social relations were consulted to inform the interpretation of data. RESULTS: The study findings suggest that participants interpreted chronic disease self-management in relation to four primary systems of support: health services for disease management; multiple sources of care, including traditional Indian medicines and the Internet, for symptom management; community groups for lifestyle management; and the family for emotional and physical care. Within these systems of support, participants identified barriers and facilitators to the maintenance of a healthy lifestyle. We focus on intra-group diversity; exploring the intersection of views and experiences by age, gender, generation and caste. CONCLUSION: The findings have implications for the design and delivery of primary care and community services which support the prevention and management of NCDs in an increasingly diverse population.

A critique of the design, implementation, and delivery of a culturally-tailored self-management education intervention: a qualitative evaluation.

BACKGROUND: Self-management education is at the forefront of addressing the increasing prevalence of chronic diseases. For those at greatest risk, such as minority-ethnic and/or socio-economically deprived groups, self-management education can be culturally-tailored to encourage behavioural change. Yet, the application of culturally appropriate material and expertise within health promotion services continues to be debated. We critique the design, implementation, and delivery of a culturally-tailored self-management intervention, with particular focus on the experiences of lay educators. METHODS: A mixed methods qualitative evaluation was undertaken to understand self-management service provision to culturally diverse communities (i.e. how components such as lay workers, group-based design, and culturally-appropriate educational material are intended to encourage behavioural change). We interviewed lay educators delivering the Chronic Disease Educator programme along with attendees, whilst observing workshops. Data were thematically analysed using a content-based constant comparison approach through a number of interpretative analytical stages. RESULTS: Lay educators felt part of the local community, relating to attendees from different races and ethnicities. However, lay educators faced challenges when addressing health beliefs and changing lifestyle practices. Culturally-tailored components aided communication, with educator's cultural awareness leading to close relationships with attendees, while the group-based design facilitated discussions of the emotional impact of illness. CONCLUSIONS: Lay educators bring with them a number of nuanced skills and knowledge when delivering self-management education. The development and training required for this role is inhibited by financial constraints at policy-level. The interpretation of being from the 'community' links with the identity and status of the lay role, overlapping notions of race, ethnicity, and language.

Patient self-management in primary care patients with mild COPD - protocol of a randomised controlled trial of telephone health coaching.

BACKGROUND: The prevalence of diagnosed chronic obstructive pulmonary disease (COPD) in the UK is 1.8%, although it is estimated that this represents less than half of the total disease in the population as much remains undiagnosed. Case finding initiatives in primary care will identify people with mild disease and symptoms. The majority of self-management trials have identified patients from secondary care clinics or following a hospital admission for exacerbation of their condition. This trial will recruit a primary care population with mild symptoms of COPD and use telephone health coaching to encourage self-management. METHODS/DESIGN: In this study, using a multi-centred randomised controlled trial (RCT) across at least 70 general practices in England, we plan to establish the effectiveness of nurse-led telephone health coaching to support self-management in primary care for people who report only mild symptoms of their COPD (MRC grade 1 and 2) compared to usual care. The intervention focuses on taking up smoking cessation services, increasing physical activity, medication management and action planning and is underpinned by behavioural change theory. In total, we aim to recruit 556 patients with COPD confirmed by spirometry with follow up at six and 12 months. The primary outcome is health related quality of life using the St Georges Respiratory Questionnaire (SGRQ). Spirometry and BMI are measured at baseline. Secondary outcomes include self-reported health behaviours (smoking and physical activity), physical activity measured by accelerometery (at 12 months), psychological morbidity, self-efficacy and cost-effectiveness of the intervention. Longitudinal qualitative interviews will explore how engaged participants were with the intervention and how embedded behaviour change was in every day practices. DISCUSSION: This trial will provide robust evidence about the effectiveness of a novel telephone health coaching intervention to promote behaviour change and prevent disease progression in patients with mild symptoms of dyspnoea in primary care. TRIAL REGISTRATION: Current controlled trials ISRCTN06710391 .