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

Abstract 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.

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. 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.

Results
Patient or Public Contribution: Patients were involved in the study design, as qualitative data co-analysts and as co-authors.

K E Y W O R D S
heart failure, medicines, process evaluation, qualitative, transitions

| INTRODUCTION
Heart failure is a major challenge to healthcare systems worldwide, with almost one million people living with heart failure in the United Kingdom. 1 Treatment involves multiple evidence-based medicines titrated to an optimal level. Without effective management, patients may have increased symptoms, reduced quality of life and increased mortality. Poor medicines management may increase avoidable hospitalization and emergency admissions, with heart failure accounting for 5% of emergency hospital admissions. 2 Despite the global emphasis on improving medicines management, there continue to be gaps in the system when patients living with heart failure transition from hospital inpatient to home.
Treatment plans may not be sufficiently communicated between health care providers. 3 Our earlier work in four English healthcare sites identified how process and systems errors can lead to poor medicines management between hospitals and the community for patients with heart failure. Patients may lack posthospitalization follow-up support and orientation around medicines. 4 Enhancing communication across the hospital community transition may facilitate medicines reconciliation and encourage improved support from community pharmacists postdischarge, reducing medicinesrelated discrepancies and errors and improving medicine use.
A Medicines at Transitions of care Intervention (MaTI) was codesigned to address these issues as part of the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) programme. 5,6 The ISCOMAT programme tested the effectiveness of MaTI in a cluster randomized controlled trial (cRCT) aimed at improving medicines management between hospital discharge and community care for patients with heart failure to improve medicines use and reduce harm. A process evaluation was conducted in parallel to the trial. 7 There is limited research on patients' experiences of interventions to improve outcomes when living with heart failure. Such insight has the potential to enhance our understanding of how interventions can be effectively implemented or may not work as intended. In this paper, we sought to understand the implementation and experience of the MaTI from the patient perspective.

| The ISCOMAT programme
For the cRCT, the aim was to recruit 2100 (1050 control, 1050 intervention) patients from cardiology wards in 42 National Health Service (NHS) acute trusts in England over 12 months, with a recruitment target of 50 patients per site. 8 A process evaluation was conducted alongside the trial. 7 In this paper, we present the findings from the process evaluation patient interviews and triangulate with the trial data on MaTI adherence.

| The ISCOMAT Medicines at Transitions intervention
The MaTI was co-designed with healthcare professionals and patients. 6  failure and know when they should seek help. Green symptoms suggest patients should keep watch, amber symptoms that they should stay alert and red symptoms that they should act, seeking appropriate support. Patients could complete a pull-out sheet to monitor their condition, to record changes in their health, along with a medicines discharge log to be completed by hospital staff.
The MaTI involved seven steps for hospital staff to complete, outlined in Figure 1. The hospital transferred the list of medicines on discharge to the community pharmacy to facilitate medicines reconciliation postdischarge. This could be undertaken by post, fax or electronic transfer, depending on the site's preference. Community pharmacists were also encouraged to offer a medicines discussion or Medicines Use Review (MUR) postdischarge. 9 Once patients returned home, they could continue to consult and use the My Medicines Toolkit to support them in optimally using their medicines and managing their heart failure. Mechanisms of actions, by which behaviour change is enacted, 10,11 were considered and a logic model was developed for the toolkit (Figure 2).

| Study design
To understand patients' experiences, we undertook an exploratory qualitative study with one-to-one semi-structured interviews with trial participants and triangulated these data with routine trial adherence data to the 'seven steps' intervention implementation (steps indicated in Figure 1). Ethical approval was granted for ISCOMAT.

| Sampling
Sites were purposively selected to include a range of university and non-university hospitals, differing methods for transferring medicines discharge information to community pharmacists and covering different geographic areas of England (Table 1).
Interviewed patients were recruited from the ISCOMAT cRCT.
The inclusion criteria were: heart failure with evidence of at least moderate left ventricular systolic dysfunction confirmed within the last 5 years, aged 18 years or over at the time of admission, planned discharged to their own home or a care home, planned discharge to within the geographical area of that cluster and capacity to provide informed consent. Exclusion criteria were patients in a terminal phase of illness/end-of-life care pathway, who were not expected to survive beyond 6 weeks from the date of discharge.
A purposive sampling strategy was employed to capture patients with a range of characteristics that may have influenced their experience of the MaTI. We therefore sought to recruit 20 patients with different ages, genders, ethnicities and heart failure diagnosis length (< or >6 months) and who were patients across six different hospital sites selected for the process evaluation 7 (see Table 1). Potential participants were provided with an information sheet and informed consent was sought. A topic guide (Supporting Information: Appendix S1), informed by the CIFR, was developed by the process evaluation team. Interviews were audio-recorded and transcribed verbatim by a professional transcription company.

| Theoretical approach
The patient interview findings were triangulated with routine trial data on adherence to the seven steps (steps indicated in Figure 1) and from community pharmacies on whether they reconciled medicines or offered a medicines discussion/MUR, for a subsample of 124/691 17.9% of intervention patients following discharge.

| Data analysis
We analysed process evaluation data before the analysis of trial outcomes to reduce bias in our interpretation (trial outcome data will be published in 2023). A rigorous data analysis process was conducted involving the Patient-Led Steering Group (PLSG) as patient co-analysts in applying the framework method. 14, 15 We have previously published the method and evaluation of the co-analysis process, which involved seven key steps: Step 1: Transcription and Anonymisation; Step2a and 2b: Familiarization with the interview; Step 3: Coding; Step 4: Developing a working analytical framework; Step 5: Applying the analytical framework; Step 6: Charting data into F I G U R E 2 Logic model. the Framework matrix and Step 7: Interpretation. 16 Data were inductively coded and the analysis was manifest, based on patients' descriptions. The qualitative interview data and quantitative routine trial adherence data were consolidated through a parallel mixed analysis process. This involved independently analysing the data and integrating the data through meta-inferences. 17 These key findings are presented in the results section. Interpretation of the patient interview and trial data were then considered in light of theory; the CFIR 13 and a logic model developed for the toolkit ( Figure 2) are highlighted in the Section 4.

| Recruitment process
Thirty-six patients were iteratively approached to ensure our sample met the criteria. Reasons for nonparticipation are outlined in Supporting Information: Appendix S2.
We recruited a range of participants according to age, gender, site and length of diagnosis (Table 2).
From the analysis, the following themes are presented as outlined in Figure 3 and explored below. Where CFIR constructs and mechanisms of action influenced themes/subthemes, these have been identified and considered.

| Engaging with the My Medicines Toolkit in hospital
Patients

| Follow-up with community pharmacy
The MaTI was designed to encourage community pharmacy to contact patients to undertake a medicines discussion or a MUR.
Community pharmacy data were available for seven interviewed patients. While limited, data indicated that only two out of seven patients received an MUR, and community pharmacists reported receiving discharge information for only one of the seven patients.
Interviews with patients corroborated this finding, with only one patient reporting being invited and having an MUR, and two patients having a medicines discussion. One patient was offered a medicines discussion but declined and a limited number of patients had impromptu discussions with the community pharmacy. Patients' engagement with community pharmacy is explored below.

| Perception of benefits of community pharmacy
A limited number of patients described benefits from community pharmacist interactions. For some patients, the community pharmacist was regarded as having the necessary knowledge and a trustworthy source of support to help with medicines. Sometimes, the toolkit enhanced patients' knowledge of what a community pharmacist could offer. However, they did not always perceive benefits from the discussions. One patient described having a detailed discussion with the community pharmacist about side effects and optimum times of day to take medicines, where previously they were more accustomed to annual medication reviews with their general practitioner (GP).
Other patients lacked an awareness of the community pharmacist role and were sceptical about whether they would be willing or able to help, despite the explanation provided in the toolkit. A key mechanism of the action noted was the environmental context (of community pharmacy) and resources.
F I G U R E 3 From hospital to home: Key themes and subthemes. [

| Reassurance during the gaps in care
Once patients were discharged from the hospital they returned home with a copy of the toolkit in most cases. The toolkit offered reassurance during the transition, until community healthcare support, such as the community heart failure nurse was available, and as a source of ongoing support between visits to health care professionals (community heart failure nurses, GPs). For these patients, wellbeing was enhanced by giving them confidence that there was a good quality source of support (toolkit) they could draw on until they received further help. One patient felt the toolkit demonstrated compassion towards people living with heart failure. Medicines management was therefore perceived to have been enhanced for some patients through the use of the toolkit at home.
The toolkit was incorporated into the daily lived experience of managing heart failure medicines leading to many patients valuing the toolkit as a source of support (links to the mechanism of action environmental context and resources). The content of the toolkit, facilitated by its design and access at home (relates to CFIR constructs Innovation characteristics and Design quality and packaging), was valued by some patients as it enhanced their knowledge of medicines, how they monitored medicines and supported their care networks.

| DISCUSSION
Care transitions between hospitals and the community can be fraught with challenges impacting patients' experiences of medicines management. [18][19][20] The MaTI was co-designed to improve such transitions by enhancing patients' understanding of their medicines, their treatment, how to manage side effects, how to monitor their condition and healthcare support including community pharmacy follow-up. 6 We, therefore, sought to explore the implementation and experience of the MaTI from the patient's perspective. with a systematic review of patient views of community pharmacies demonstrating low awareness of roles. 21 Patients were often unaware of the range of services on offer, regarding the pharmacy as a dispensary, place to purchase medicines or discuss minor ailments.
One study found that few patients were aware of MURs and the New Medicines Service. 22 A lack of understanding was associated with low take-up of services. To increase awareness, building on convenience and relationships between pharmacists and patients was recommended. 21 Moreover, some patients may not engage with community pharmacy due to their way of managing medicines. A typology of patient self-management of medicines for chronic conditions found that patients may be 'Self-determined and highly self-managing', seeking information from multiple sources, 'Security-seeking and selfmanaging' enhancing knowledge already received from health professionals, 'Dependent with limited self-managing' relying more on discussions with health professionals, or 'Co-managing with close family' where the family member is a source of information. 23 Our findings indicated that some patients could have combinations of such types, for example, comanaging with close family while also being selfdetermined to self-manage, and using resources such as the toolkit, and having discussions with health care professionals.

| Implications for research, strengths and limitations
The key strengths included our methods in both co-designing 6 and co-evaluating 16 25,26 and there have been advances in this approach. 27 However, in practice some patients may not feel that they should or can be involved, perhaps, particularly those who have lived with heart failure for many years, before these advances. Further research such as a Phase 2 explanatory trial could test these mechanisms and the logic model. Once the trial outcomes are known we will further contextualize our findings.

| CONCLUSION
The MaTI intervention has the potential to enhance patients' lived experiences of medicines management, building on their existing support networks, improving their ability to monitor and seek support and increasing their knowledge of medicines. Patients felt that the key to this was the engagement of healthcare professionals in implementing the intervention, raising patients' awareness of its importance. The MaTI intervention demonstrates the potential benefit of this type of tool in supporting patients with heart failure to improve medicines management across the hospital/home transition. The patient experience of its use provides critical insights into its value to better support patient care, with the aim of improving patient experience and outcomes.

AUTHOR CONTRIBUTIONS
All authors revised the manuscript critically for important intellectual content and made substantial contributions to conception and design. Catherine Powell drafted the manuscript. All authors have given final approval for the version to be published. Each author has participated sufficiently in the work to take public responsibility for appropriate portions of the content and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.