Experiences of patients with heart failure with medicines at transition intervention: Findings from the process evaluation of the Improving the Safety and Continuity of Medicines management at Transitions of care (ISCOMAT) programme.

BACKGROUND: Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co-designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient-held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. DESIGN: Twenty one-to-one semi-structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co-analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. RESULTS: Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. CONCLUSION: Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design, as qualitative data co-analysts and as co-authors.

Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot.

INTRODUCTION: Heart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients. METHODS AND ANALYSIS: ISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and planned discharge to the geographical area of the cluster will be recruited. The MaTI consists of training for staff, a toolkit for participants, transfer of discharge information to community pharmacies and a medicines reconciliation/review. Treatment as usual is determined by local policy and practices. The primary outcome is a composite of all-cause mortality and heart failure-related hospitalisation at 12 months postregistration obtained from national electronic health records. The key secondary outcome is continued prescription of guideline-indicated therapies at 12 months measured via patient-reported data and Hospital Episode Statistics. The trial contains a parallel mixed-methods process evaluation and an embedded health economics study. ETHICS AND DISSEMINATION: The study obtained approval from the Yorkshire and the Humber-Bradford Leeds Research Ethics Committee; REC reference 18/YH/0017. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. Amendments to the protocol are disseminated to all relevant parties as required. TRIAL REGISTRATION NUMBER: ISRCTN66212970; Pre-results.

A non-randomised feasibility study of an intervention to optimise medicines at transitions of care for patients with heart failure.

BACKGROUND: Heart failure affects 26 million people globally, and the optimal management of medicines is crucial for patients, particularly when their care is transferred between hospital and the community. Optimising clinical outcomes requires well-calibrated cross-organisational processes with staff and patients responding and adapting to medicines changes. The aim of this study was to assess the feasibility of implementing a complex intervention (the Medicines at Transitions Intervention; MaTI) co-designed by patients and healthcare staff. The purpose of the intervention was to optimise medicines management across the gaps between secondary and primary care when hospitals handover care. The study objectives were to (1) assess feasibility through meeting specified progression criteria to proceed to the trial, (2) assess if the intervention was acceptable to staff and patients, and (3) determine whether amendment or refinement would be needed to enhance the MaTI. METHODS: The feasibility of the MaTI was tested in three healthcare areas in the North of England between July and October 2017. Feasibility was measured and assessed through four agreed progression to trial criteria: (1) patient recruitment, (2) patient receipt of a medicines toolkit, (3) transfer of discharge information to community pharmacy, and (4) offer of a community pharmacy medicines review/discussion or medicines reconciliation. From the cardiology wards at each of the three NHS Acute Trusts (sites), 10 patients (aged ≥ 18 years) were recruited and introduced to the 'My Medicines Toolkit' (MMT). Patients were asked to identify their usual community pharmacy or nominate a pharmacy. Discharge information was transferred to the community pharmacy; pharmacists were asked to reconcile medicines and invited patients for a medicines use review (MUR) or discussion. At 1 month following discharge, all patients were sent three questionnaire sets: quality-of-life, healthcare utilisation, and a patient experience survey. In a purposive sample, 20 patients were invited to participate in a semi-structured interview about their experiences of the MaTI. Staff from hospital and primary care settings involved in patients' care were invited to participate in a semi-structured interview. Patient and staff interviews were analysed using Framework Analysis. Questionnaire completion rates were recorded and data were descriptively analysed. RESULTS: Thirty-one patients were recruited across three sites. Eighteen staff and 18 patients took part in interviews, and 19 patients returned questionnaire sets. All four progression to trial criteria were met. We identified barriers to patient engagement with the intervention in hospital, which were compounded by patients' focus on returning home. Some patients described not engaging in discussions with staff about medicines and lacking motivation to do so because they were preoccupied with returning home. Some patients were unable or unwilling to attend a community pharmacy in person for a medicines review. Roles and responsibilities for delivering the MaTI were different in the three sites, and staff reported variations in time spent on MaTI activities. Staff reported some work pressures and staff absences that limited the time they could spend talking to patients about their medicines. Clinical teams reported that recording a target dose for heart failure medicines in patient-held documentation was difficult as they did not always know the ideal or tolerable dose. The majority of patients reported receiving the patient-held documentation. More than two-thirds reported being offered a MUR by their community pharmacists. CONCLUSIONS: Delivery of the Medicines at Transitions Intervention (MaTI) was feasible at all three sites, and progression to trial criteria were met. Refinements were found to be necessary to overcome identified barriers and strengthen delivery of all steps of the intervention. Necessary changes to the MaTI were identified along with amendments to the implementation plan for the subsequent trial. Future implementation needs to take into account the complexity of medicines management and adaptation to local context.

Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial.

INTRODUCTION: A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention. METHODS AND ANALYSIS: The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021. ETHICS AND DISSEMINATION: Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. TRIAL REGISTRATION NUMBER: ISRCTN66212970.

Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.

BACKGROUND: Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service. METHODS: The primary aim was to assess the feasibility and acceptability of conducting research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory-informed analysis. RESULTS: We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups-followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial. CONCLUSIONS: EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.

Gaps, traps, bridges and props: a mixed-methods study of resilience in the medicines management system for patients with heart failure at hospital discharge.

INTRODUCTION: Poor medicines management places patients at risk, particularly during care transitions. For patients with heart failure (HF), optimal medicines management is crucial to control symptoms and prevent hospital readmission. This study explored the concept of resilience using HF as an example condition to understand how the system compensates for known and unknown weaknesses. METHODS: We explored resilience using a mixed-methods approach in four healthcare economies in the north of England. Data from hospital site observations, healthcare staff and patient interviews, and documentary analysis were collected between June 2016 and March 2017. Data were synthesised and analysed using framework analysis. RESULTS: Interviews were conducted with 45 healthcare professionals, with 20 patients at three time points and 189 hours of observation were undertaken. We identified four primary inter-related themes concerning organisational resilience. These were named as gaps, traps, bridges and props. Gaps were discontinuities in processes that had the potential to result in poorly optimised medicines. Traps were features of the system that could produce errors or unintended adverse medication events. Bridges were features of the medicines management system that promoted safety and continuity which ensured that, despite varying conditions, care could be delivered successfully. Props were informal, temporary or impromptu actions taken by patients or healthcare staff to avoid potential adverse events. CONCLUSION: The numerous opportunities for HF patient safety to be compromised and for suboptimal medicines management during this common care transition are mitigated by system resilience. Cross-organisational bridges and temporary fixes or 'props' put in place by patients and carers, healthcare teams and organisations are critical for safe and optimal care to be delivered in the face of continued system pressures.

The NHS Health Check programme: insights from a qualitative study of patients.

OBJECTIVE: To provide an insight into the process of patients receiving Health Checks and to determine the extent to which patients were supported to reduce the risks of developing cardiovascular disease through behaviour change. METHODS: Semi-structured qualitative interviews were undertaken with 45 patients about their initial experiences of undertaking a Health Check. They were followed up 1 year later to assess whether the behavioural changes reported after the Health Check had been maintained. RESULTS: Patients expressed a need for individualized support in order to stay motivated and to adopt long-term diet and lifestyle changes. CONCLUSIONS: Those involved in the delivery of the programme need to adopt a consistent approach in terms of explaining the purpose of the Health Check, communicating risk and consider the challenges and the barriers that influence behaviour change.

Arrhythmia care co-ordinators: Their impact on anxiety and depression, readmissions and health service costs.

BACKGROUND: In 2005, the UK Department of Health recommended that a new role, the arrhythmia care coordinator (ACC), be created to guide patients through the diagnosis and treatment for arrhythmia. The belief was that this would improve the efficiency of care and improve their quality of life. The British Heart Foundation provided funding for 32 such posts, all of which were filled by arrhythmia specialist nurses, and commissioned an evaluation of the new service to assess its impact on patients. AIMS: This paper focuses on the impact of the ACCs on their patients' levels of anxiety and depression, hospital readmissions and costs to the National Health Service (NHS). METHODS: From 2008 to 2010, using questionnaires, we conducted a longitudinal audit of the psychological status of the patients referred to the ACCs; we also assessed the ACCs' impact on readmissions and cost benefits to the NHS using UK Hospital Episode Statistics. RESULTS: We found high levels of anxiety and depression amongst patients. Nearly one-third were at the 'borderline' or 'clinically anxious' and 18% were at the 'borderline' or 'clinically depressed' level at their first assessment with small changes at follow-up. In arrhythmia specialist nurse sites, readmission rates were reduced by half. After deducting the cost of the ACCs and their support, the estimated annual saving was £29,357 per ACC. CONCLUSION: This evaluation has shown that the NHS saves £29,357 per year over and above the costs of employing a British Heart Foundation ACC and that all arrhythmia centres should be encouraged to employ an appropriate number of such specialists.

Lessons learned from England's Health Checks Programme: using qualitative research to identify and share best practice.

BACKGROUND: This study aimed to explore the challenges and barriers faced by staff involved in the delivery of the National Health Service (NHS) Health Check, a systematic cardiovascular disease (CVD) risk assessment and management program in primary care. METHODS: Data have been derived from three qualitative evaluations that were conducted in 25 General Practices and involved in depth interviews with 58 staff involved all levels of the delivery of the Health Checks. Analysis of the data was undertaken using the framework approach and findings are reported within the context of research and practice considerations. RESULTS: Findings indicated that there is no 'one size fits all' blueprint for maximising uptake although success factors were identified: evolution of the programme over time in response to local needs to suit the particular characteristics of the patient population; individual staff characteristics such as being proactive, enthusiastic and having specific responsibility; a supportive team. Training was clearly identified as an area that needed addressing and practitioners would benefit from CVD specific baseline training and refresher courses to keep them up to date with recent developments in the area. However there were other external factors that impinged on an individual's ability to provide an effective service, some of these were outside the control of individuals and included cutbacks in referral services, insufficient space to run clinics or general awareness of the Health Checks amongst patients. CONCLUSIONS: The everyday experiences of practitioners who participated in this study suggest that overall, Health Check is perceived as a worthwhile exercise. But, organisational and structural barriers need to be addressed. We also recommend that clear referral pathways be in place so staff can refer patients to appropriate services (healthy eating sessions, smoking cessation, and exercise referrals). Local authorities need to support initiatives that enable data sharing and linkage so that GP Practices are informed when patients take up services such as smoking cessation or alcohol harm reduction programmes run by social services.

The role of a new arrhythmia specialist nurse in providing support to patients and caregivers.

In 2005, the English Department of Health developed a National Service Framework for the identification and treatment of Arrhythmia. A new specialist role was recommended, the Arrhythmia Care Co-ordinator (ACC), to guide patients through their illness and coordinate their care. In 2006, to implement this policy, the British Heart Foundation (BHF) sponsored 32 new nursing ACC staff posts across England and Wales. The BHF also sponsored an evaluation to investigate the impact of ACC support on patients and caregivers, with 30 patients (18 men, 22 women) and 10 caregivers being drawn from a purposive sample across seven arrhythmia treatment centres. Two main key themes emerged to describe the patients' experience of the new service: personalized coordinated care and learning to live with their condition.

The use of biomedicine, complementary and alternative medicine, and ethnomedicine for the treatment of epilepsy among people of South Asian origin in the UK.

BACKGROUND: Studies have shown that a significant proportion of people with epilepsy use complementary and alternative medicine (CAM). CAM use is known to vary between different ethnic groups and cultural contexts; however, little attention has been devoted to inter-ethnic differences within the UK population. We studied the use of biomedicine, complementary and alternative medicine, and ethnomedicine in a sample of people with epilepsy of South Asian origin living in the north of England. METHODS: Interviews were conducted with 30 people of South Asian origin and 16 carers drawn from a sampling frame of patients over 18 years old with epilepsy, compiled from epilepsy registers and hospital databases. All interviews were tape-recorded, translated if required and transcribed. A framework approach was adopted to analyse the data. RESULTS: All those interviewed were taking conventional anti-epileptic drugs. Most had also sought help from traditional South Asian practitioners, but only two people had tried conventional CAM. Decisions to consult a traditional healer were taken by families rather than by individuals with epilepsy. Those who made the decision to consult a traditional healer were usually older family members and their motivations and perceptions of safety and efficacy often differed from those of the recipients of the treatment. No-one had discussed the use of traditional therapies with their doctor. The patterns observed in the UK mirrored those reported among people with epilepsy in India and Pakistan. CONCLUSION: The health care-seeking behaviour of study participants, although mainly confined within the ethnomedicine sector, shared much in common with that of people who use global CAM. The appeal of traditional therapies lay in their religious and moral legitimacy within the South Asian community, especially to the older generation who were disproportionately influential in the determination of treatment choices. As a second generation made up of people of Pakistani origin born in the UK reach the age when they are the influential decision makers in their families, resort to traditional therapies may decline. People had long experience of navigating plural systems of health care and avoided potential conflict by maintaining strict separation between different sectors. Health care practitioners need to approach these issues with sensitivity and to regard traditional healers as potential allies, rather than competitors or quacks.

'What really annoys me is people take it like it's a disability', epilepsy, disability and identity among people of Pakistani origin living in the UK.

This paper reports on a study of Pakistani people with epilepsy. It explores their attitudes towards their condition, others' attitudes, its impact on their lives, and the extent to which they considered themselves as disabled. Epilepsy was variously interpreted within biomedical, folk and religious paradigms. In line with popular understandings, participants associated disability with stable, permanent and visible physical impairments and did not consider themselves as disabled. However, they also recognised a social dimension to their experience. Much of the distress and disadvantage they experienced was socially determined, both through direct prejudice and discrimination, and indirectly through a fear of others' negative reactions. However, the invisible and unpredictable nature of epilepsy meant that they could conceal their condition and thereby mitigate its social effects. 'Disability' was not experienced as a static and permanent state but as a potential identity that was both contingent and contested. The literature portrays people moving from biomedical to social interpretations of disability. However, the tensions experienced by people in the study were more between competing religious interpretations of their condition and, to some extent, between religious and medical approaches. Conceptions of disability, which are presented in the literature as antagonistic and mutually exclusive, were experienced as different dimensions reflecting the complexity of experience. The paper concludes by suggesting that for many people, for whom disability is an ambiguous, contingent and contested identity, public self-identification as disabled is an unrealistic goal. Rather than conceiving of disability as primarily physical or primarily social, it would be better construed as a complex interweaving of multiple factors--physical, environmental, socio-cultural and psychological factors.

South Asians and epilepsy: exploring health experiences, needs and beliefs of communities in the north of England.

PURPOSE: To examine the beliefs and experiences of South Asians with epilepsy and the extent of provision of appropriate information and accessible services for them by health professionals. METHODS: Qualitative interviews with 30 South Asians with epilepsy, 16 carers and 10 health professionals. In addition, two focus groups were held with 16 South Asians without epilepsy recruited from community centers. The interview sample was divided by religious groupings (Hindus, Sikhs and Muslims). Fieldwork was conducted in Bradford and Leeds (England). RESULTS: Beliefs that epilepsy is caused by spirit possession (Muslims) or attributable to sins committed in a past life (Sikhs and Hindus) were reported as being widely held among South Asians living both in the UK and the Indian subcontinent, although few informants themselves subscribed to such views. Compliance with conventional medication was high; however, those who experienced seizures most often were most likely to turn to traditional South Asian therapies. Most informants used both treatments simultaneously. The main issues regarding the provision of services were: lack of appropriate information and advice; language and communication barriers; problems in interaction with health professionals. Also discussed were the potential merits of attending support groups. Greatest dissatisfaction was expressed in relation to primary care, whereas the highest praise was reserved for specialist epilepsy nurses. CONCLUSIONS: Our findings show both similarities and differences between participants' experiences, where gender, age or other aspects of personal biography can be as important as religion, culture or country of origin. Furthermore, the impact of being diagnosed with epilepsy can be exacerbated by structural impediments to accessing information and appropriate services.

Religious beliefs about causes and treatment of epilepsy.

BACKGROUND: It has been acknowledged that religious and complementary therapies are commonly used among South Asian communities in the UK. However, little is known about their religious beliefs in relation to epilepsy and the type of South Asian therapies that they use to treat the condition. AIM: To explore the influences of spiritual and religious beliefs on explanation of the cause of epilepsy, and the choice of treatment in people of South Asian origin who have epilepsy. DESIGN OF STUDY: Qualitative study using interviews with patients, carers, health professionals, and focus groups of people from minority ethnic communities. SETTING: Bradford and Leeds. METHOD: Semi-structured individual interviews with 20 Muslims, six Sikhs, and four Hindus with epilepsy; 16 nominated carers (family members, friends); 10 health professionals (specialist GPs, neurologists, specialists nurses, social workers, community GPs); and two focus groups with a total of 16 South Asians without epilepsy. RESULTS: It was found that over half of responders attributed their illness to fate and the will of God, or as punishment for sins of a past life. Some patients had experienced prejudice from people who believed that their epilepsy was contagious. A strong network of traditional healers was found, providing a parallel system of health care in the UK and on the Indian subcontinent. People turned to religiospiritual treatments in desperation for a cure, often under the influence of their families after the perceived failure of Western medicine. Such treatments were viewed as complementary rather than as an alternative to Western medication. Younger people in particular expressed considerable scepticism about the effectiveness of these traditional South Asian treatments. CONCLUSIONS: In this study's South Asian sample, patients commonly turned to traditional healers in search of better health. Health professionals should be aware of the belief systems of these patients and understand the types of treatments in common use. Although these treatments might potentially compete with Western health care, they are used as an adjunct rather than a substitute. Patients have a 'healthy' scepticism about the effectiveness of such treatments, and adherence to medical therapy does not appear to be affected.

Evidence of cultural hybridity in responses to epilepsy among Pakistani muslims living in the UK.

OBJECTIVES: To examine how people from Bradford's Pakistani Muslim community experience living with epilepsy. Specifically, the paper addresses social interactions and negotiations with care providers and considers how different understandings of epilepsy are integrated. METHODS: Interviews were conducted with a sample of Bradford's Pakistani Muslim community (n = 20). Interviews were analysed to identify themes and significant areas of shared concern. RESULTS: This paper identifies popular, professional and folk sectors contributing to an individual's 'health system'. Where sectors overlap, zones of hybridity are created: that is, a person might simultaneously seek help from a doctor and from a religious healer, or might offer explanations for seizures that include neurological and spiritual components. DISCUSSION: While there are many similarities between the experiences of these minority ethnic community members and published work on the lived experience of epilepsy in other communities, there are also important differences that service providers need to recognize and respond to. Differences include forms of cultural expression and specific language needs. Improving communication between professionals and persons with epilepsy needs to be prioritized.