Workforce thresholds and the non-linear association between registered nurse staffing and care quality in long-term residential care: A retrospective longitudinal study of English care homes with nursing.

BACKGROUND: Care needs amongst 425,000 dependent older residents in English care homes are becoming more complex. The quality of care in these homes is influenced by staffing levels, especially the presence of registered nurses (RNs). Existing research on this topic, often US-focused and relying on linear assumptions, has limitations. This study aims to investigate the non-linear relationship between RN staffing and care quality in English care homes using machine learning and administrative data from two major care home providers. METHODS: A retrospective observational study was conducted using data from two English care home providers. Each was analysed separately due to variations in data reporting and care processes. Various care quality indicators and staffing metrics were collected for a 3.5-year period. Regression analysis and machine learning (random forest) were employed to identify non-linear relationships. Ethical approval was obtained for the study. RESULTS: Using linear methods, higher skill mix - more care provided by RNs - was associated with lower incidence of adverse outcomes, such as urinary tract infections and hospitalisations. However, non-linear skill mix-outcome relationship modelling revealed both low and high skill mix levels were linked to higher risks. The effects of agency RN usage varied between providers, increasing risks in one but not the other. DISCUSSION: The study highlights the cost implications of increasing RN staffing establishments to improve care quality, suggesting a non-linear relationship and an optimal staffing threshold of around one-quarter of care provided by nurses. Alternative roles, such as care practitioners, merit exploration for meeting care demands whilst maintaining quality. This research underscores the need for a workforce plan for social care in England. It advocates for the incorporation of machine learning models alongside traditional regression-based methods. Our results may have limited generalisability to smaller providers and experimental research to redesign care processes effectively may be needed. CONCLUSION: RNs are crucial for quality in care homes. Contrary to the assumption that higher nurse staffing necessarily leads to better care quality, this study reveals a nuanced, non-linear relationship between RN staffing and care quality in English care homes. It suggests that identifying an optimal staffing threshold, beyond which increasing nursing inputs may not significantly enhance care quality may necessitate reconsidering care system design and (human) resource allocation. Further experimental research is required to elucidate resource-specific thresholds and further strengthen evidence for care home staffing. TWEETABLE ABSTRACT: How much nursing care is needed to assure quality in care homes? Evidence from 2 English care home providers shows that nurse sensitive outcomes (an indicator of quality) are better when ~25 % of care is provided by nurses. Nurse shortages increase risks for residents.

Relationship between staff and quality of care in care homes: StaRQ mixed methods study.

Background: Quality of life and care varies between and within the care homes in which almost half a million older people live and over half a million direct care staff (registered nurses and care assistants) work. The reasons are complex, understudied and sometimes oversimplified, but staff and their work are a significant influence. Objective(s): To explore variations in the care home nursing and support workforce; how resident and relatives' needs in care homes are linked to care home staffing; how different staffing models impact on care quality, outcomes and costs; how workforce numbers, skill mix and stability meet residents' needs; the contributions of the care home workforce to enhancing quality of care; staff relationships as a platform for implementation by providers. Design: Mixed-method (QUAL-QUANT) parallel design with five work packages. WP1 - two evidence syntheses (one realist); WP2 - cross-sectional survey of routine staffing and rated quality from care home regulator; WP3 - analysis of longitudinal data from a corporate provider of staffing characteristics and quality indicators, including safety; WP4 - secondary analysis of care home regulator reports; WP5 - social network analysis of networks likely to influence quality innovation. We expressed our synthesised findings as a logic model. Setting: English care homes, with and without nursing, with various ownership structures, size and location, with varying quality ratings. Participants: Managers, residents, families and care home staff. Findings: Staffing's contribution to quality and personalised care requires: managerial and staff stability and consistency; sufficient staff to develop 'familial' relationships between staff and residents, and staff-staff reciprocity, 'knowing' residents, and skills and competence training beyond induction; supported, well-led staff seeing modelled behaviours from supervisors; autonomy to act. Outcome measures that capture the relationship between staffing and quality include: the extent to which resident needs and preferences are met and culturally appropriate; resident and family satisfaction; extent of residents living with purpose; safe care (including clinical outcomes); staff well-being and job satisfaction were important, but underacknowledged. Limitations: Many of our findings stem from self-reported and routine data with known biases - such as under reporting of adverse incidents; our analysis may reflect these biases. COVID-19 required adapting our original protocol to make it feasible. Consequently, the effects of the pandemic are reflected in our research methods and findings. Our findings are based on data from a single care home operator and so may not be generalised to the wider population of care homes. Conclusions: Innovative and multiple methods and theory can successfully highlight the nuanced relationship between staffing and quality in care homes. Modifiable characteristics such as visible philosophies of care and high-quality training, reinforced by behavioural and relational role modelling by leaders can make the difference when sufficient amounts of consistent staff are employed. Greater staffing capacity alone is unlikely to enhance quality in a cost-effective manner. Social network analysis can help identify the right people to aid adoption and spread of quality and innovation. Future research should focus on richer, iterative, evaluative testing and development of our logic model using theoretically and empirically defensible - rather than available - inputs and outcomes. Study registration: This study is registered as PROSPERO CRD42021241066 and Research Registry registration: 1062. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/144/29) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 8. See the NIHR Funding and Awards website for further award information.

This study was about the relationship between staffing and quality in care homes. Almost half a million older people live in care homes in England. Why quality of care and quality of life for residents vary so much between and within homes is unknown, but staff and the ways they work are likely to be important. Researching staffing and quality is difficult: quality means different things to different people and a lot of things shape how quality feels to residents, families and staff. In the past, researchers have oversimplified the problem to study it and may have missed important influences. We took a more complex view. In five interlinked work packages, we collected and analysed: (1) research journal articles; (2) national data from different care homes; (3) data from a large care organisation to look at what it is about staffing that influences quality; (4) reports and ratings of homes from the Care Quality Commission; and (5) we looked at the networks between staff in homes that shape how quality improvement techniques might spread. We used theories about how our findings might be linked to plan for this data collection and analysis. The results were combined into something called a 'logic model' ­ a diagram and explanation that make it easier for managers, researchers and people interested in care homes to see how staffing influences quality. Staffing considerations that might improve quality include: not swapping managers too much; having sufficient and consistent staff for family-like relationships in homes and putting residents' needs first; supporting staff and giving them freedom to act; and key staff leading by example. Research examining care home quality should capture those aspects that mean the most to residents, their families and staff.

Interventions for reducing anticholinergic medication burden in older adults-a systematic review and meta-analysis.

INTRODUCTION: Anticholinergic medications block the neurotransmitter acetylcholine in the brain and peripheral nervous system. Many medications have anticholinergic properties, and the cumulative effect of these medications is termed anticholinergic burden. Increased anticholinergic burden can have short-term side effects such as dry mouth, blurred vision and urinary retention as well as long-term effects including dementia, worsening physical function and falls. METHODS: We carried out a systematic review (SR) with meta-analysis (MA) looking at randomised controlled trials addressing interventions to reduce anticholinergic burden in older adults. RESULTS: We identified seven papers suitable for inclusion in our SR and MA. Interventions included multi-disciplinary involvement in medication reviews and deprescribing of AC medications. Pooled data revealed no significant difference in outcomes between control and intervention group for falls (OR = 0.76, 95% CI: 0.52-1.11, n = 647), cognition (mean difference = 1.54, 95% CI: -0.04 to 3.13, n = 405), anticholinergic burden (mean difference = 0.04, 95% CI: -0.11 to 0.18, n = 710) or quality of life (mean difference = 0.04, 95% CI: -0.04 to 0.12, n = 461). DISCUSSION: Overall, there was no significant difference with interventions to reduce anticholinergic burden. As we did not see a significant change in anticholinergic burden scores following interventions, it is likely other outcomes would not change. Short follow-up time and lack of training and support surrounding successful deprescribing may have contributed.

CompreHensive geriAtRician-led MEdication Review (CHARMER): protocol for a feasibility study of a hospital deprescribing behaviour change intervention.

INTRODUCTION: Over 50% of older adults are prescribed a medicine where the risk of harm outweighs the chances of benefit. During a hospital admission, older adults and carers expect medicines to be reviewed for appropriateness and any inappropriate medicines proactively deprescribed. While the principle of proactive deprescribing is an expectation of good prescribing practice, it is yet to become routine. The CompreHensive geriAtRician-led MEdication Review (CHARMER) study aims to develop and test a five-component behaviour change intervention to equip geriatricians and pharmacists to proactively deprescribe inappropriate medicines with older adults in hospital. This study aims to test the feasibility and acceptability of study processes and CHARMER implementation. METHODS AND ANALYSIS: A two-arm purposive allocation feasibility study is being undertaken at four acute hospitals in England, UK (three intervention and one control). The target sample is 400 patients across all hospitals. Primary outcome measures are: (1) participant recruitment rate and (2) participant attrition rate. Secondary outcome measures are: (1) hospital readmission rate; (2) mortality rate and (3) quality of life. Quantitative data will be checked for completeness and quality, and practitioner and patient demographics descriptively analysed. We will undertake a rapid qualitative analysis on observations, interviews and study meeting minutes data. A subsequent thematic analysis will be undertaken with codes mapped to the Theoretical Domains Framework and Normalisation Process Theory. Triangulation of qualitative and quantitative data will be undertaken. ETHICS AND DISSEMINATION: Ethics approval was obtained from Wales Research Ethics Committee 1 (IRAS ID 312494) and study approval from the Health Research Authority (22/WA/0087). Informed consent will be sought from all hospital staff involved in data collection activities and for patients involved in enhanced data collection activities. The findings of this study will be disseminated in peer-reviewed journals and conference presentations. TRIAL REGISTRATION: ISRCTN11899506.

The extent of anticholinergic burden across an older Welsh population living with frailty: cross-sectional analysis of general practice records.

BACKGROUND: Anticholinergic medicines are associated with adverse outcomes for older people. However, little is known about their use in frailty. The objectives were to (i) investigate the prevalence of anticholinergic prescribing for older patients, and (ii) examine anticholinergic burden according to frailty status. METHODS: Cross-sectional analysis of Welsh primary care data from the Secure Anonymised Information Linkage databank including patients aged ≥65 at their first GP consultation between 1 January and 31 December 2018. Frailty was identified using the electronic Frailty Index and anticholinergic burden using the Anticholinergic Cognitive Burden (ACB) scale. Descriptive analysis and logistic regression were conducted to (i) describe the type and frequency of anticholinergics prescribed; and (ii) to estimate the association between frailty and cumulative ACB score (ACB-Sum). RESULTS: In this study of 529,095 patients, 47.4% of patients receiving any prescription medications were prescribed at least one anticholinergic medicine. Adjusted regression analysis showed that patients with increasing frailty had higher odds of having an ACB-Sum of >3 compared with patients who were fit (mild frailty, adj OR 1.062 (95%CI 1.061-1.064), moderate frailty, adj OR 1.134 (95%CI 1.131-1.136), severe frailty, adj OR 1.208 (95%CI 1.203-1.213)). CONCLUSIONS: Anticholinergic prescribing was high in this older population. Older people with advancing frailty are exposed to the highest anticholinergic burden despite being the most vulnerable to the associated adverse effects. Older people with advancing frailty should be considered for medicines review to prevent overaccumulation of anticholinergic medications, given the risks of functional and cognitive decline that frailty presents.

Person-centred deprescribing for patients living with frailty: a qualitative interview study and proposal of a collaborative model.

OBJECTIVES: (1) Present deprescribing experiences of patients living with frailty, their informal carers and healthcare professionals; (2) interpret whether their experiences are reflective of person-centred/collaborative care; (3) complement our findings with existing evidence to present a model for person-centred deprescribing for patients living with frailty, based on a previous collaborative care model. METHODS: Qualitative design in English primary care (general practice). Semi-structured interviews were undertaken immediately post-deprescribing and 5/6 weeks later with nine patients aged 65+ living with frailty and three informal carers of patients living with frailty. Fourteen primary care professionals with experience in deprescribing were also interviewed. In total, 38 interviews were conducted. A two-staged approach to data analysis was undertaken. KEY FINDINGS: Three themes were developed: attitudes, beliefs and understanding of medicines management and responsibility; attributes of a collaborative, person-centred deprescribing consultation; organisational factors to support person-centred deprescribing. Based on these findings and complementary to existing evidence, we offer a model for person-centred deprescribing for patients living with frailty. CONCLUSIONS: Previous models of deprescribing for patients living with frailty while, of value, do not consider the contextual factors that govern the implementation and success of models in practice. In this paper, we propose a novel person-centred model for deprescribing for people living with frailty, based on our own empirical findings, and the wider evidence base.

Barriers and facilitators of implementing proactive deprescribing within primary care: a systematic review.

OBJECTIVE: Proactive deprescribing - identifying and discontinuing medicines where harms outweigh benefits - can minimise problematic polypharmacy, but has yet to be implemented into routine practice. Normalisation process theory (NPT) can provide a theory-informed understanding of the evidence base on what impedes or facilitates the normalisation of routine and safe deprescribing in primary care. This study systematically reviews the literature to identify barriers and facilitators to implementing routine safe deprescribing in primary care and their effect on normalisation potential using NPT.PubMed, MEDLINE, Embase, Web of Science, International Pharmaceutical Abstracts, CINAHL, PsycINFO and The Cochrane Library were searched (1996-2022). Studies of any design investigating the implementation of deprescribing in primary care were included. The Mixed Methods Appraisal Tool and the Quality Improvement Minimum Quality Criteria Set were used to appraise quality. Barriers and facilitators from included studies were extracted and mapped to the constructs of NPT. KEY FINDINGS: A total of 12,027 articles were identified, 56 articles included. In total, 178 barriers and 178 facilitators were extracted and condensed into 14 barriers and 16 facilitators. Common barriers were negative deprescribing perceptions and suboptimal deprescribing environments, while common facilitators were structured education and training on proactive deprescribing and utilising patient-centred approaches. Very few barriers and facilitators were associated with reflexive monitoring, highlighting a paucity of evidence on how deprescribing interventions are appraised. SUMMARY: Through NPT, multiple barriers and facilitators were identified that impede or facilitate the implementation and normalisation of deprescribing in primary care. However, more research is needed into the appraisal of deprescribing post-implementation.

A rapid review of interventions to improve medicine self-management for older people living at home.

BACKGROUND: As people age, they are more likely to develop multiple long-term conditions that require complicated medicine regimens. Safely self-managing multiple medicines at home is challenging and how older people can be better supported to do so has not been fully explored. AIM: This study aimed to identify interventions to improve medicine self-management for older people living at home and the aspects of medicine self-management that they address. DESIGN: A rapid review was undertaken of publications up to April 2022. Eight databases were searched. Inclusion criteria were as follows: interventions aimed at people 65 years of age or older and their informal carers, living at home. Interventions needed to include at least one component of medicine self-management. Study protocols, conference papers, literature reviews and articles not in the English language were not included. The results from the review were reported through narrative synthesis, underpinned by the Resilient Healthcare theory. RESULTS: Database searches returned 14,353 results. One hundred and sixty-seven articles were individually appraised (full-text screening) and 33 were included in the review. The majority of interventions identified were educational. In most cases, they aimed to improve older people's adherence and increase their knowledge of medicines. Only very few interventions addressed potential issues with medicine supply. Only a minority of interventions specifically targeted older people with either polypharmacy, multimorbidities or frailty. CONCLUSION: To date, the emphasis in supporting older people to manage their medicines has been on the ability to adhere to medicine regimens. Most interventions identify and target deficiencies within the patient, rather than preparing patients for problems inherent in the medicine management system. Medicine self-management requires a much wider range of skills than taking medicines as prescribed. Interventions supporting older people to anticipate and respond to problems with their medicines may reduce the risk of harm associated with polypharmacy and may contribute to increased resilience in the system. PATIENT OR PUBLIC CONTRIBUTION: A patient with lived experience of medicine self-management in older age contributed towards shaping the research question as well as the inclusion and exclusion criteria for this review. She is also the coauthor of this article. A patient advisory group oversaw the study.

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial.

OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received. TRIAL REGISTRATION: ISRCTN 17847169.

Co-design of a behaviour change intervention to equip geriatricians and pharmacists to proactively deprescribe medicines that are no longer needed or are risky to continue in hospital.

BACKGROUND: Trials of hospital deprescribing interventions have demonstrated limited changes in practitioner behaviour. Our previous research characterised four barriers and one enabler to geriatricians and pharmacists deprescribing in hospital that require addressing by a behaviour change intervention. Six behaviour change techniques (BCTs) have also been selected by the target audience using the hospital Deprescribing Implementation Framework (hDIF). This research aimed to co-design and operationalise the content, mode of delivery and duration/intensity of the six selected BCTs to develop the CompreHensive geriAtRician-led MEdication Review (CHARMER) deprescribing intervention. METHODS: We established co-design panels at three hospitals representing contextual factors likely to influence CHARMER implementation. Panels comprised geriatricians, pharmacists and other hospital staff likely to be involved in implementation. We convened two rounds of co-design workshops with each hospital to design a prototype for each BCT, which went for feedback at a final workshop attended by all three hospital panels. RESULTS: The six BCTs were co-designed into an intervention comprising:(1&2) Pharmacists' workshop with pros and cons of deprescribing activities, and videos of salient patient cases3 Regular geriatrician and pharmacist deprescribing briefings4 Videos of geriatricians navigating challenging deprescribing consultations5 Hospital deprescribing action plan6 Dashboard to benchmark deprescribing activitiesAutomated prompts to flag high-risk patients for deprescribing and a primary and secondary care deprescribing forum were proposed as additional BCTs by stakeholders. These were later excluded as they were not fidelitous to the theoretical determinants of geriatricians' and pharmacists' deprescribing behaviours. CONCLUSIONS: This study illustrates the integration of theory and co-design methodology with the target audience and staff likely to be involved in implementation of a hospital deprescribing behaviour change intervention. The development of an intervention that remains faithful to the underpinning mechanisms of action of behaviour change is a strength of this approach.

Pharmacist-independent prescriber deprescribing in UK care homes: Contextual factors associated with increased activity.

AIMS: The Care Home Independent Pharmacist Prescriber Study (CHIPPS) process evaluation hypothesized that contextual factors influenced the likelihood of deprescribing by pharmacist-independent prescribers. The aim of this paper is to test this hypothesis. METHODS: From CHIPPS study data, medications deprescribed totalled 284 for 370 residents in UK care homes. Regression analysis was used to describe the relationship between the number of medicines stopped and contextual factors (number of residents cared for, pharmacist employment within associated medical practice, previous care home experience, hours active within trial, years' experience as a pharmacist and as a prescriber). RESULTS: Number of residents and pharmacist-independent prescriber employment within a medical practice were positive predictors of deprescribing. CONCLUSION: Previous experiences were not related to deprescribing likelihood. Increasing the number of residents increases the opportunity for deprescribing and therefore this relationship is intuitive. The location within a medical practice is an interesting finding that requires further exploration to understand its exact nature.

Co-designing an intervention to improve the process of deprescribing for older people living with frailty in the United Kingdom.

BACKGROUND: In older people living with frailty, polypharmacy can lead to preventable harm like adverse drug reactions and hospitalization. Deprescribing is a strategy to reduce problematic polypharmacy. All stakeholders should be actively involved in developing a person-centred deprescribing process that involves shared decision-making. OBJECTIVE: To co-design an intervention, supported by a logic model, to increase the engagement of older people living with frailty in the process of deprescribing. DESIGN: Experience-based co-design is an approach to service improvement, which uses service users and providers to identify problems and design solutions. This was used to create a person-centred intervention with the potential to improve the quality and outcomes of the deprescribing process. A 'trigger film' showing older people talking about their healthcare experiences was created and facilitated discussions about current problems in the deprescribing process. Problems were then prioritized and appropriate solutions were developed. The review located the solutions in the context of current processes and procedures. An ideal care pathway and a complex intervention to deliver better care were developed. SETTING AND PARTICIPANTS: Older people living with frailty, their informal carers and professionals living and/or working in West Yorkshire, England, UK. Deprescribing was considered in the context of primary care. RESULTS: The current deprescribing process differed from an ideal pathway. A complex intervention containing seven elements was required to move towards the ideal pathway. Three of these elements were prototyped and four still need development. The complex intervention responded to priorities about (a) clarity for older people about what was happening at all stages in the deprescribing process and (b) the quality of one-to-one consultations. CONCLUSIONS: Priorities for improving the current deprescribing process were successfully identified. Solutions were developed and structured as a complex intervention. Further work is underway to (a) complete the prototyping of the intervention and (b) conduct feasibility testing. PATIENT OR PUBLIC CONTRIBUTION: Older people living with frailty (and their informal carers) have made a central contribution, as collaborators, to ensure that a complex intervention has the greatest possible potential to enhance the experience of deprescribing medicines.

Enhancing deprescribing: A qualitative understanding of the complexities of pharmacist-led deprescribing in care homes.

The English National Overprescribing Review identified that older people often take eight or more medicines a day. The report recommended pharmacists in primary care should take responsibility for addressing polypharmacy. Overprescribing is a safety concern in care homes as approximately half of older care home residents are prescribed at least one medicine that is unnecessary or now harmful. This predisposes them to adverse outcomes including hospitalisation and mortality. Deprescribing is the planned activity of stopping or reducing a medicine that may no longer be appropriate. Deprescribing, when performed by a pharmacist, is a multidisciplinary activity requiring close communication with general practitioners (GPs) and care home staff. A recently completed trial that integrated pharmacists with prescribing rights into older peoples' care homes found significant variation in proactive deprescribing activity. The aim of the current study was to specifically explore beliefs and practices of deprescribing in care homes. A qualitative approach was adopted to examine individual, social and contextual factors that acted as enablers and barriers to pharmacist deprescribing in care homes. Semi-structured interviews were conducted with participants of the previous study (16 pharmacists, 6 GPs and 7 care home staff from Northern Ireland, Scotland and England). Using thematic analysis, we identified two themes: (a) Structures and systems affecting deprescribing, that is the context in which deprescribing happened, including team involvement and routine practices in GP surgeries and care homes; (b) Balancing risks when deprescribing, that is the perception of individual risk and social barriers were mitigated by understanding the medical background of residents. This supported the clinical understanding that risks from overprescribing were greater than risks from deprescribing. While deprescribing can involve all health professionals in the primary care team, these results suggest the pharmacist is well placed to lead the process; by having both clinical competence and professional willingness to drive this activity forward.

Developing a core outcome set for hospital deprescribing trials for older people under the care of a geriatrician.

BACKGROUND: Half of older people are prescribed unnecessary/inappropriate medications that are not routinely deprescribed in hospital hence there is a need for deprescribing trials. We aimed to develop a Core Outcome Set (COS) for deprescribing trials for older people under the care of a geriatrician during hospital admission. METHODS: We developed a list of potentially relevant outcomes from the literature. Using a two-round Delphi survey of stakeholder groups representing older people and carers, hospital clinicians, hospital managers, and ageing/deprescribing researchers, each outcome was scored according to Grading of Recommendations Assessment, Development and Evaluation, followed by two consensus workshops to finalise the COS. RESULTS: Two hundred people completed Round 1 and 114 completed Round 2. Representing all stakeholder groups, 10 people participated in workshop 1 and 10 in workshop 2. Six outcomes were identified as most important, feasible and acceptable to collect in a trial: number of prescribed medicines stopped; number of prescribed medicines with dosage reduced; quality of life; mortality; adverse drug events and number of hospital stays. Three other outcomes were identified as important, but currently too burdensome to collect: number of potentially inappropriate medicines prescribed; burden from medication routine; and medication-related admissions to hospital. CONCLUSIONS: A COS represents the minimum outcomes that should be collected and reported. Whilst uncommon practice for COS development, the value of considering outcome collection feasibility is demonstrated by the removal of three potential outcomes that, if included, may have compromised COS uptake due to challenges with collecting the data.

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.

Barriers and facilitators of successful deprescribing as described by older patients living with frailty, their informal carers and clinicians: a qualitative interview study.

OBJECTIVE: To explore the barriers/facilitators to deprescribing in primary care in England from the perspectives of clinicians, patients living with frailty who reside at home, and their informal carers, drawing on the Theoretical Domains Framework to identify behavioural components associated with barriers/facilitators of the process. DESIGN: Exploratory qualitative study. SETTING: General practice (primary care) in England. PARTICIPANTS: 9 patients aged 65+ living with frailty who attended a consultation to reduce or stop a medicine/s. 3 informal carers of patients living with frailty. 14 primary care clinicians including general practitioners, practice pharmacists and advanced nurse practitioners. METHODS: Qualitative semistructured interviews took place with patients living with frailty, their informal carers and clinicians. Patients (n=9) and informal carers (n=3) were interviewed two times: immediately after deprescribing and 5/6 weeks later. Clinicians (n=14) were interviewed once. In total, 38 interviews were undertaken. Framework analysis was applied to manage and analyse the data. RESULTS: 6 themes associated with facilitators and barriers to deprescribing were generated, respectively, with each supported by between two and three subthemes. Identified facilitators of deprescribing with patients living with frailty included shared decision-making, gradual introduction of the topic, clear communication of the topic to the patient and multidisciplinary working. Identified barriers of deprescribing included consultation constraints, patients' fear of negative consequences and inaccessible terminology and information. CONCLUSIONS: This paper offers timely insight into the barriers and facilitators to deprescribing for patients living with frailty within the context of primary care in England. As deprescribing continues to grow in national and international significance, it is important that future deprescribing interventions acknowledge the current barriers and facilitators and their associated behavioural components experienced by clinicians, patients living with frailty and their informal carers to improve the safety and effectiveness of the process.

Mapping the resilience performance of community pharmacy to maintain patient safety during the Covid-19 pandemic.

BACKGROUND: The first UK wave of the Covid-19 pandemic in 2020 placed unprecedented stress on community pharmacy. Various policies and initiatives were announced during this period to support community pharmacy to continue to perform in a manner that prioritised patient safety. However, little is understood about how these policies and initiatives were implemented by staff working in community pharmacy, and the system adaptions and responses that were initiated to maintain patient safety. OBJECTIVE: The study aimed to investigate how staff working in UK community pharmacy during the first waves of the COVID-19 pandemic in 2020 responded and adapted to system stressors to maintain patient safety. METHODS: We adopted a qualitative interview approach, underpinned by Resilient Healthcare theory, with interview data collected between July 2020 and January 2021. Data were synthesised and analysed using Framework Analysis. RESULTS: 23 community pharmacy staff from England and Scotland were interviewed. We identified five themes supported by between two and six sub-themes: 1. Covid-19, an impending threat to system; 2. Patient safety stressors during the first waves of Covid-19; 3. Altering the system, responding to system stressors; 4. Monitoring and adjusting and 5. Learning for the future. CONCLUSION: Privileging the accounts of community pharmacy staff working on the frontline during the pandemic illuminated how responses and adaptions were developed and deployed, how continual monitoring occurred, and the factors that supported or hindered system resilience. The key learning derived from this study can serve to shorten the gap between 'work as imagined' and 'work as done', and in doing so, support the future resilience performance of community pharmacy during future outbreaks of Covid-19 or similar events.

Process evaluation for the Care Homes Independent Pharmacist Prescriber Study (CHIPPS).

BACKGROUND: Medicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation. METHOD: Intervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework. RESULTS: PCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention. CONCLUSIONS: The intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established. TRIAL REGISTRATION: The definitive RCT was registered with the ISRCTN registry (registration number  ISRCTN 17847169 ).

Associations Between Anticholinergic Medication Exposure and Adverse Health Outcomes in Older People with Frailty: A Systematic Review and Meta-analysis.

INTRODUCTION: There are robust associations between use of anticholinergic medicines and adverse effects in older people. However, the nature of these associations for older people living with frailty is yet to be established. OBJECTIVES: The aims were to identify and investigate associations between anticholinergics and adverse outcomes in older people living with frailty and to investigate whether exposure is associated with greater risks according to frailty status. METHODS: MEDLINE, CINAHL, EMBASE, Cochrane Database of Systematic Reviews, Web of Science and PsycINFO were searched to 1 August 2019. Observational studies reporting associations between anticholinergics and outcomes in older adults (average age ≥ 65 years) that reported frailty using validated measures were included. Primary outcomes were physical impairment, cognitive dysfunction, and change in frailty status. Risk of bias was evaluated using the Cochrane Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Meta-analysis was undertaken where appropriate. RESULTS: Thirteen studies (21,516 participants) were included (ten community, one residential aged-care facility and two hospital studies). Observed associations included reduced ability for chair standing, slower gait speeds, poorer physical performance, increased risk of falls and mortality. Conflicting results were reported for grip strength, timed up and go test, cognition and activities of daily living. No associations were observed for transitions between frailty states, psychological wellbeing or benzodiazepine-related adverse reactions. There was no clear evidence of differences in risks according to frailty status. CONCLUSIONS: Anticholinergics are associated with adverse outcomes in older people living with frailty; however, the literature has significant methodological limitations. There is insufficient evidence to suggest greater risks based on frailty, and there is an urgent need to evaluate this further in well-designed studies stratifying by frailty.