Single German centre experience with patient journey and care-relevant needs in amyloidosis: The German AMY-NEEDS research and care program.

BACKGROUND: Amyloidosis is a rare multi-system disorder associated with frequently delayed diagnosis, enormous disease burden and psychosocial distress. METHODS: Systematic assessment of needs was performed by a subtype-spanning questionnaire-based survey within the AMY-NEEDS research and care program. RESULTS: 118 patients with proven amyloidosis (62.7% ATTR, 22.0% AL, 15.3% other forms) were included in August 2020 until February 2021 (mean age 71.2 ±11.3 years; 30% women). The median diagnostic delay between onset of symptoms and diagnosis was 9.0 (range: 2.5; 33.0) months. Local health care providers (HCPs) play a central role on the way to diagnosis. Diagnosis itself typically requires a clinical but not necessarily a university setting. In the treatment phase, the focus moves to the amyloidosis centre as primary contact and coordinator, with general practitioners (GPs) acting predominantly as a contact point in crisis and link to additional services. About half of patients reported impaired quality of life and one third suffering from anxiety and depressed mood, respectively. The majority of patients talk about their concerns with close caregivers and local HCPs. Advance care planning is a relevant, yet insufficiently met need. CONCLUSION: The journey of patients with amyloidotic disease, their contact partners and needs at different stages were characterized in detail within the German health care system. An amyloidosis-specific care concept has to master the multitude of interfaces connecting the numerous treatment providers involved with the amyloidosis centre and GPs as key players. Telemedical approaches could be a promising and well-accepted option allowing optimal coordination and communication.

Expectation of clinical decision support systems: a survey study among nephrologist end-users.

BACKGROUND: Chronic kidney disease (CKD), a major public health problem with differing disease etiologies, leads to complications, comorbidities, polypharmacy, and mortality. Monitoring disease progression and personalized treatment efforts are crucial for long-term patient outcomes. Physicians need to integrate different data levels, e.g., clinical parameters, biomarkers, and drug information, with medical knowledge. Clinical decision support systems (CDSS) can tackle these issues and improve patient management. Knowledge about the awareness and implementation of CDSS in Germany within the field of nephrology is scarce. PURPOSE: Nephrologists' attitude towards any CDSS and potential CDSS features of interest, like adverse event prediction algorithms, is important for a successful implementation. This survey investigates nephrologists' experiences with and expectations towards a useful CDSS for daily medical routine in the outpatient setting. METHODS: The 38-item questionnaire survey was conducted either by telephone or as a do-it-yourself online interview amongst nephrologists across all of Germany. Answers were collected and analysed using the Electronic Data Capture System REDCap, as well as Stata SE 15.1, and Excel. The survey consisted of four modules: experiences with CDSS (M1), expectations towards a helpful CDSS (M2), evaluation of adverse event prediction algorithms (M3), and ethical aspects of CDSS (M4). Descriptive statistical analyses of all questions were conducted. RESULTS: The study population comprised 54 physicians, with a response rate of about 80-100% per question. Most participants were aged between 51-60 years (45.1%), 64% were male, and most participants had been working in nephrology out-patient clinics for a median of 10.5 years. Overall, CDSS use was poor (81.2%), often due to lack of knowledge about existing CDSS. Most participants (79%) believed CDSS to be helpful in the management of CKD patients with a high willingness to try out a CDSS. Of all adverse event prediction algorithms, prediction of CKD progression (97.8%) and in-silico simulations of disease progression when changing, e. g., lifestyle or medication (97.7%) were rated most important. The spectrum of answers on ethical aspects of CDSS was diverse. CONCLUSION: This survey provides insights into experience with and expectations of out-patient nephrologists on CDSS. Despite the current lack of knowledge on CDSS, the willingness to integrate CDSS into daily patient care, and the need for adverse event prediction algorithms was high.

Impact of the COVID-19 pandemic on ongoing health research: an ad hoc survey among investigators in Germany.

OBJECTIVES: To gain insights into the impact of the COVID-19 pandemic on ongoing health research projects, using projects from a selected funding programme in Germany as an example. DESIGN: Online survey and validation workshop. SETTING: Lockdowns and social distancing policies impact on clinical and public health research in various forms, especially if unrelated to COVID-19. Research institutions have reduced onsite activities, data are often collected remotely, and during the height of the crisis, clinical researchers were partially forced to abandon their projects in favour of front-line care. PARTICIPANTS SURVEY: 120 investigators of health research projects across Germany, performed between 15 and 25 May 2020; workshop: 32 investigators, performed on 28 May 2020. RESULTS: The response rate (78%) showed that the survey generated significant interest among investigators. 85 responses were included for analysis, and the majority of investigators (93%) reported that their projects were affected by the pandemic, with many (80%) stating that data collection was not possible as planned, and they could not carry out interventions as intended (67%). Other impacts were caused by staff being unavailable, for example, through child or elder care commitments or because of COVID-19 quarantine or illness. Investigators also reported that publications were delayed or not feasible at all (56%), and some experienced problems with PhD or Masters theses (18%). The majority of investigators had mitigation strategies in place such as adjustment of data collection methods using digital tools (46%) or of project implementation in general (46%), others made changes in research design or research questions (27%). CONCLUSIONS: The COVID-19 pandemic has severely impacted on health research projects. The main challenge is now to mitigate negative effects and to improve long-term resilience in health research. The pandemic has also acted as a driver of innovation and change, for example, by accelerating the use of digital methods.

Adoption, non-adoption, and abandonment of a personal electronic health record: case study of HealthSpace.

OBJECTIVE: To evaluate the policy making process, implementation by NHS organisations, and patients' and carers' experiences of efforts to introduce an internet accessible personal electronic health record (HealthSpace) in a public sector healthcare system. DESIGN: Mixed method, multilevel case study. SETTING: English National Health Service; the basic HealthSpace technology (available throughout England) and the advanced version (available in a few localities where this option had been introduced) were considered. MAIN OUTCOME MEASURES: National statistics on invitations sent, HealthSpace accounts created, and interviews and ethnographic observation of patients and carers. Data analysis was informed by a socio-technical approach which considered macro and micro influences on both adoption and non-adoption of innovations, and by the principles of critical discourse analysis. PARTICIPANTS: 56 patients and carers (of whom 21 opened a basic HealthSpace account, 20 had diabetes but were not initially using HealthSpace, and 15 used advanced HealthSpace accounts to exchange messages with their general practitioner), 3000 pages of documents (policies, strategies, business plans, minutes of meetings, correspondence), observational field notes, and 160 interviews with policy makers, project managers, and clinical staff. RESULTS: Between 2007 and October 2010, 172 950 people opened a basic HealthSpace account. 2913 (0.13% of those invited) opened an advanced account, compared with 5-10% of the population anticipated in the original business case. Overall, patients perceived HealthSpace as neither useful nor easy to use and its functionality aligned poorly with their expectations and self management practices. Those who used email-style messaging were positive about its benefits, but enthusiasm beyond three early adopter clinicians was low, and fewer than 100 of 30 000 patients expressed interest. Policy makers' hopes that "deploying" HealthSpace would lead to empowered patients, personalised care, lower NHS costs, better data quality, and improved health literacy were not realised over the three year evaluation period. CONCLUSION: Unless personal electronic health records align closely with people's attitudes, self management practices, identified information needs, and the wider care package (including organisational routines and incentive structures for clinicians), the risk that they will be abandoned or not adopted at all is substantial. Conceptualising such records dynamically (as components of a socio-technical network) rather than statically (as containers for data) and employing user centred design techniques might improve their chances of adoption and use. The findings raise questions about how eHealth programmes in England are developed and approved at policy level.

Adoption and non-adoption of a shared electronic summary record in England: a mixed-method case study.

OBJECTIVE: To evaluate a national programme to develop and implement centrally stored electronic summaries of patients' medical records. DESIGN: Mixed-method, multilevel case study. SETTING: English National Health Service 2007-10. The summary care record (SCR) was introduced as part of the National Programme for Information Technology. This evaluation of the SCR considered it in the context of national policy and its frontline implementation and use in three districts. Participants and methods Quantitative data (cumulative records created nationally plus a dataset of 416 325 encounters in participating primary care out-of-hours and walk-in centres) were analysed statistically. Qualitative data (140 interviews including policy makers, managers, clinicians, and software suppliers; 2000 pages of ethnographic field notes including observation of 214 clinical consultations; and 3000 pages of documents) were analysed thematically and interpretively. RESULTS: Creating individual SCRs and supporting their adoption and use was a complex, technically challenging, and labour intensive process that occurred more slowly than planned. By early 2010, 1.5 million such records had been created. In participating primary care out-of-hours and walk-in centres, an SCR was accessed in 4% of all encounters and in 21% of encounters where one was available; these figures were rising in some but not all sites. The main determinant of SCR access was the identity of the clinician: individual clinicians accessed available SCRs between 0 and 84% of the time. When accessed, an SCR seemed to support better quality care and increase clinician confidence in some encounters. There was no direct evidence of improved safety, but findings were consistent with a rare but important positive impact on preventing medication errors. SCRs sometimes contained incomplete or inaccurate data, but clinicians drew judiciously on these data along with other sources. SCR use was not associated with shorter consultations or reduction in onward referral. Successful introduction of SCRs depended on interaction between multiple stakeholders from different worlds (clinical, political, technical, commercial) with different values, priorities, and ways of working. The programme's fortunes seemed to turn on the ability of change agents to bridge these different institutional worlds, align their conflicting logics, and mobilise implementation effort. CONCLUSIONS: Benefits of centrally stored electronic summary records seem more subtle and contingent than many stakeholders anticipated, and clinicians may not access them. Complex interdependencies, inherent tensions, and high implementation workload should be expected when they are introduced on a national scale.

'Never heard of it'- understanding the public's lack of awareness of a new electronic patient record.

BACKGROUND: The introduction of electronic patient records that are accessible by multiple providers raises security issues and requires informed consent - or at the very least, an opportunity to opt out. Introduction of the Summary Care Record (SCR) (a centrally stored electronic summary of a patient's medical record) in pilot sites in the UK was associated with low awareness, despite an intensive public information programme that included letters, posters, leaflets, and road shows. AIM: To understand why the public information programme had limited impact and to learn lessons for future programmes. METHODS: Linguistic and communications analysis of components of the programme, contextualized within a wider mixed-method case study of the introduction of the SCR in pilot sites. Theoretical insights from linguistics and communication studies were applied. RESULTS: The context of the SCR pilots and the linked information programme created inherent challenges which were partially but not fully overcome by the efforts of campaigners. Much effort was put into designing the content of a mail merge letter, but less attention was given to its novelty, linguistic style, and rhetorical appeal. Many recipients viewed this letter as junk mail or propaganda and discarded it unread. Other components of the information programme were characterized by low visibility, partly because only restricted areas were participating in the pilot. Relatively little use was made of interpersonal communication channels. CONCLUSION: Despite ethical and legal imperatives, informed consent for the introduction of shared electronic records may be difficult to achieve through public information campaigns. Success may be more likely if established principles of effective mass and interpersonal communication are applied.

Introduction of shared electronic records: multi-site case study using diffusion of innovation theory.

OBJECTIVE: To explore the introduction of a centrally stored, shared electronic patient record (the summary care record (SCR)) in England and draw wider lessons about the implementation of large scale information technology projects in health care. DESIGN: Multi-site, mixed method case study applying utilisation focused evaluation. SETTING: Four early adopter sites for the SCR in England-three in urban areas of relative socioeconomic deprivation and the fourth in a relatively affluent rural area. Data sources and analysis Data included 250 staff interviews, 1500 hours of ethnographic observation, interviews and focus groups with 170 patients and carers, 2500 pages of correspondence and documentary evidence, and incorporation of relevant surveys and statistics produced by others. These were analysed by using a thematic approach drawing on (and extending) a theoretical model of complex change developed in a previous systematic review. Main findings The mixed fortunes of the SCR programme in its first year were largely explained by eight interacting influences. The first was the SCR's material properties (especially technical immaturity and lack of interoperability) and attributes (especially the extent to which potential adopters believed the benefits outweighed the risks). The second was adopters' concerns (especially about workload and the ethicality of sharing "confidential" information on an implied consent model). The third influence was interpersonal influence (for example, opinion leaders, champions, facilitators), and the fourth was organisational antecedents for innovation (for example past experience with information technology projects, leadership and management capacity, effective data capture systems, slack resources). The fifth was organisational readiness for the SCR (for example, innovation-system fit, tension for change, power balances between supporters and opponents, baseline data quality). The sixth was the implementation process (including the nature of the change model and the extent to which new routines associated with the SCR aligned with existing organisational routines). The seventh influence was the nature and quality of links between different parts of the system, and the final one was the wider environment (especially the political context of the programme). CONCLUSION: Shared electronic records are not plug-in technologies. They are complex innovations that must be accepted by individual patients and staff and also embedded in organisational and inter-organisational routines. This process is heavily influenced at the micro-level by the material properties of the technology, individuals' attitudes and concerns, and interpersonal influence; at the meso-level by organisational antecedents, readiness, and operational aspects of implementation; and at the macro-level by institutional and socio-political forces. A case study approach and multi-level theoretical analysis can illuminate how contextual factors shape, enable, and constrain new, technology supported models of patient care.

Patients' attitudes to the summary care record and HealthSpace: qualitative study.

OBJECTIVE: To document the views of patients and the public towards the summary care record (SCR, a centrally stored medical record drawn from the general practice record) and HealthSpace (a personal health organiser accessible through the internet from which people can view their SCR), with a particular focus on those with low health literacy, potentially stigmatising conditions, or difficulties accessing health care. DESIGN: 103 semistructured individual interviews and seven focus groups. SETTING: Three early adopter primary care trusts in England where the SCR and HealthSpace are being piloted. All were in areas of relative socioeconomic deprivation. PARTICIPANTS: Individual participants were recruited from general practice surgeries, walk-in centres, out of hours centres, and accident and emergency departments. Participants in focus groups were recruited through voluntary sector organisations; they comprised advocates of vulnerable groups and advocates of people who speak limited English; people with HIV; users of mental health services; young adults; elderly people; and participants of a drug rehabilitation programme. METHODS: Participants were asked if they had received information about the SCR and HealthSpace and about their views on shared electronic records in different circumstances. RESULTS: Most people were not aware of the SCR or HealthSpace and did not recall receiving information about it. They saw both benefits and drawbacks to having an SCR and described a process of weighing the former against the latter when making their personal choice. Key factors influencing this choice included the nature of any illness (especially whether it was likely to lead to emergency care needs); past and present experience of healthcare and government surveillance; the person's level of engagement and health literacy; and their trust and confidence in the primary healthcare team and the wider NHS. Overall, people with stigmatising illness were more positive about the SCR than people who claimed to speak for "vulnerable groups." Misconceptions about the SCR were common, especially confusion about what data it contained and who would have access to it. Most people were not interested in recording their medical data or accessing their SCR via HealthSpace, but some saw the potential for this new technology to support self management and lay care for those with chronic illness. CONCLUSION: Despite an extensive information programme in early adopter sites, the public remains unclear about current policy on shared electronic records, though most people view these as a positive development. The "implied consent" model for creating and accessing a person's SCR should be revisited, perhaps in favour of "consent to view" at the point of access.

Human and organisational aspects of remote patient monitoring in residential care homes.

Demographic changes in the population, with a growing proportion of elderly people, make the efficient and effective provision of healthcare for this age group an increasingly important issue. We examine the organisational and human aspects of introducing a Remote Patient Monitoring (RPM) system that uses wireless and broadband networks into three residential care homes in the UK. Stakeholders were identified, and semi-structured one-to-one interviews were carried out in order to identify issues deemed most important to each group. The work is novel, as it requires examination of the issues of communication between healthcare workers in several primary and secondary care organisations. The key finding was the need to identify the changes in working practice and interpersonal communication. A key factor in particular was the change in relationships: staff in the remote centre needing to learn to seek support when reporting and requesting assistance for a problem; and for the staff at the health centres to respond appropriately.

The impact of remote patient monitoring in managing silent myocardial infarction in a residential home setting.

OBJECTIVE: We describe the impact of a remote patient monitoring (RPM) system implemented in residential care homes. METHODS: The service was designed to support the staff in managing patients that presented with non-specific symptoms. The system allows vital signs to be transmitted to a central server. The medical professional may then observe the data and provide advice to the staff on optimum management. Our system has been evaluated for 18 months and largely provided routine measurements. RESULTS: During this period, three residents presented with non specific symptoms that were investigated using the RPM system. One patient had symptoms over a weekend, and the problem remained unresolved on Monday. The resident continued to only complain of feeling unwell, but reported no specific symptoms. Vital signs data were then sent and the doctor consulted. The electrocardiogram (ECG) showed significant ST segment changes. Repetitive measurements of the ECG, heart rate, and oxygen saturation of the blood (SpO2) were made every 5 minutes. The resident had a history angina and CHF. The staff was asked to give the patient aspirin and anti-angina drug. The ECG was seen to resolve after 40 minutes, but the SpO2 was falling. The decision to send to hospital was taken at this point. Two further patients with significant ECG changes were observed during the period of the project, and again both were asymptomatic, but in these cases the condition resolved and hospital admission was avoided. Feedback from users has been very positive. Staff found that the system gave them support to make better informed decisions on patient management, especially when determining whether to admit the person to hospital when reaching end of life. Further comments were that the system also proved useful to reassure relatives during these final stages. CONCLUSION: Our project demonstrated that significant cardiac events occur in the elderly population of residential homes without symptoms; and that RPM can be used by non medical staff to manage asymptomatic patients in the community.

Optimum design of remote patient monitoring systems.

Remote patient monitoring (RPM) of physiological measurements offers the potential to provide high quality care to elderly, chronically and acutely ill people in their home environment, while making effective use of healthcare resources. However, despite its clearly demonstrated potential, RPM has not become an integrated part of patient care so far. In this paper, we undertake an extensive systematic literature review to identify the typical setup of RPM projects and services in the UK. We then propose a solution for a clinically and organizationally more integrated service, which is based in primary care. Key to the design is the involvement of other healthcare services such as social care, the emergency department of a hospital, and out-of-hours General Practitioner services, and also the involvement of the patient and their carer/s. This allows a team-based approach with information-sharing across different healthcare sectors, and offers maximum continuity of care for the patient.

Evaluation of the practical feasibility and acceptability of home monitoring in residential homes.

Three residential homes to the north-west of London, with their associated medical centres, were equipped with telemonitors to measure several variables, including seven-lead electrocardiogram, blood pressure, oxygen saturation, heart rate, temperature and respiration. The monitors could be operated by non-medical personnel. After recording, the data were transmitted via the Internet to a server. A total of 24 patients with a variety of chronic conditions were monitored regularly for a period of one year. Data transmission was found to be unreliable on occasions and was improved by extending the wireless network in the homes. Data access and presentation were considered acceptable, although suggestions for minor changes were made. No discernible impact on disease management, diagnosis or care was observed as a result of the monitoring. However, interviewees saw several potential benefits and patient acceptance was very good. The monitoring was found to be generally acceptable and feasibility was considered to have been largely proven.

A new monitoring service for long term residential care.

eVital, a European funded project, aims to investigate the issues in the provision of vital signs monitoring services in the community. For the UK pilot, services to monitor the vital signs of patients in residential care homes by remote health care workers have been established. In particular, the aim was to allow the resident's own GP to observe the ECG, blood pressure, SpO2, temperature and respiration whilst still in the health centre and be able to advise on the most appropriate action should a crisis occur. As outcomes, this pilot project was designed to determine feasibility, channels of communication between key players and assess the technology. Trials have been under way for four months and preliminary results are promising. Residential home staff have commented on the extra level security they feel in being able to "summon" medical support for residents for whom they may have concern. Patient's relatives have also commented on the reassurance they experience from knowing that the resident is being monitored.