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Introduction: Evidence indicates that there are major gaps in pharmaceutical care service provision and limited research on interventions to optimise medication use for patients with vision impairment. The United Kingdom's Medical Research Council (MRC) advocates a systematic approach for the development and evaluation of an intervention. The aim of this research was to develop a novel theory-based intervention to support medicines optimisation for patients with vision impairment. Methods: This research focuses on the development and feasibility testing of the IDC-VI (Intervention for Dispensing and Counselling for the Visually Impaired). Firstly, a systematic review was undertaken to assess the types and effectiveness of interventions provided by pharmacists. Qualitative interview-based research was then conducted with pharmacists and patients/caregivers. The Theoretical Domains Framework (TDF) was utilised as the underlying theoretical lens. Pharmacists' interviews investigated the barriers/facilitators to the provision of medication dispensing and counselling while patients'/caregivers' interviews explored the barriers/facilitators to obtaining and taking medications. Key TDF domains were identified from both sets of interviews. The planned intervention targeted the pharmacists' behaviour, and the key TDF domains from pharmacists' interviews were mapped to behaviour change techniques (BCTs). Finally, BCTs were operationalised into a workable intervention which was then tested in a small feasibility study. Results: The systematic review highlighted the paucity of pharmacist-led interventions. Findings from pharmacists' interviews led to the identification of eight key TDF domains which were linked to eight BCTs. Interviews with patients/caregivers identified six key TDF domains. The eight BCTs formed the IDC-VI. Feasibility testing demonstrated favourable opinions from pharmacists and patients/caregivers but a number of modifications were suggested. Discussion and conclusion: This thesis provides theory-informed insights into the determinants of patients', caregivers', and pharmacists' behaviours. The IDC-VI will require a number of amendments before being tested in a larger pilot trial in preparation for a randomised controlled trial.

The aim of this thesis was to identify the current evidence base for medicines optimisation interventions for frail older patients in primary care, and to explore the role of community pharmacists in optimising medicines use for frail older people using a mixed-methods approach. A systematic review was conducted to identify medicines optimisation interventions for community-dwelling frail older patients. Community pharmacists' knowledge of frailty, experiences with frail older patients, and perspectives of frailty and medicines optimisation were explored through semi-structured interviews(n=15), followed by a questionnaire distributed to all registered community pharmacy premises in Northern Ireland (n=528). Comparative analyses were conducted for a sub-set of questionnaire items included in a questionnaire administered to Canadian pharmacists. Finally, an educational resource package for community pharmacists about frailty was developed and evaluated. The systematic review identified a lack of medicines optimisation interventions delivered to frail older patients in primary care; only one study met the inclusion criteria for this review. However, this study did highlight the potential role that community pharmacists could play in delivering interventions to this patient population. Interviews conducted with community pharmacists identified that community pharmacists lacked knowledge about frailty. This finding was also supported by data from questionnaire respondents and similar gaps in knowledge were observed with Canadian community pharmacists. Positive feedback was obtained regarding the educational resource. The research presented in this thesis has identified a lack of high-quality evidence for medicines optimisation interventions for frail older people in primary care. Whilst community pharmacists are ideally placed to deliver such interventions, gaps in their knowledge about frailty must be addressed. Further research is therefore needed to address these knowledged eficits and to develop and evaluate medicines optimisation interventions. The views of other relevant key stakeholders, including frail older patients, their family members, and carers, should also inform future work.

Introduction: Primary care in the United Kingdom (UK) faces unprecedented challenges due to the growing complexity of an ageing population and their care needs, and a workforce crisis. Practice-based pharmacists (PBPs) have been introduced into general practice across the UK to relieve some of the pressures within primary care. However, there is little existing UK literature that has explored healthcare professionals' (HCPs') views about PBP integration and how this role has evolved. Therefore, this thesis aimed to explore the role of PBPs in primary care in Northern Ireland (NI) and their impact on the delivery of care in general practice. Methods: A mixed methods approach (i.e. systematic review, quantitative and qualitative evaluations, and a Delphi consensus exercise) was used across the four studies contained in this thesis. The first study comprised a systematic review to assess the types and effectiveness of PBPs' interventions seeking to optimise medicines management for older people (aged ≥65 years) with both multimorbidity and polypharmacy. The second study was exploratory in nature, using a cross-sectional questionnaire to explore general practitioners' (GPs') experiences with, views of, and attitudes towards PBPs in NI. The third study was a qualitative investigation to explore the views and experiences of HCPs about PBPs' integration into general practice and their impact on primary healthcare delivery in NI. Finally, a Delphi study was conducted to reach consensus on a core set of clinical skills required for pharmacist prescribers working in general practice. Results: The systematic review found that PBP-led interventions had improved a number of outcomes (e.g.reduced the number of medicines-related problems and improved appropriateness of prescribing). However, there was limited effect on the number of medicines prescribed, adherence to medicines, or no effect on other outcomes such as quality of life. The second study reported that the majority of GPs had positive views about the role of PBPs and positive attitudes towards collaboration with PBPs. The qualitative study corroborated the questionnaire study findings and found that PBPs had integrated well and were perceived to have had a positive impact on primary healthcare delivery. Delphi study produced a core set of clinical skills for prescribing PBPs that can serve as a reference for other countries developing policies on pharmacist roles. Discussion and conclusion: The work contained in this thesis has added to the evidence base regarding PBPs' role and their impact in primary care and the findings may have implications for future developments in order to extend integration of PBPs within general practice. The positive views and attitudes of HCPs regarding the role of PBPs and their impact on primary care in NI may encourage other countries to integrate pharmacists into general practice where there are health workforce shortages. Future research should explore patients' views of the role of the PBP as well as their ability to differentiate between role of the CP and that of the PBP.

Introduction: Heterogeneity of outcomes measured in trials to improve antimicrobial stewardship (AMS) in care homes has impeded synthesising evidence and producing definitive conclusions. This thesis aimed to develop a core outcome set (COS) for use in trials focusing on improving AMS in care homes. Methods: The research presented in this thesis followed current guidelines for development of a COS (COMET) and selection of outcome measurement instruments (OMIs) for the COS (COSMIN). A systematic review was conducted to evaluate the effectiveness of randomised controlled trials (RCTs) to improve AMS in care homes and to determine outcomes reported in these studies. A qualitative study was undertaken to explore outcomes deemed important to key stakeholders comprising researchers, healthcare professionals, and family members of care home residents. Subsequently, a series of consensus procedures with relevant stakeholders were carried out to reach consensus on outcomes that should be included in the COS for use in trials aimed at improving AMS in care homes. Finally, methodology suggested by the COSMIN guidelines was followed to select OMIs available in the literature for outcomes in the COS. Results: The systematic review identified six RCTs with 28 outcomes reported and found the interventions had limited effect on improvement of antimicrobial prescribing. Interviews with 41 key stakeholders in the qualitative study revealed 49 outcomes that were deemed important to them, including 40 additional outcomes which had not been used in previous RCTs. Outcomes identified in the systematic review and the qualitative study were reviewed and refined by the research team to produce an inventory of 14 outcomes. This inventory was presented in an online Delphi survey with 82 participants from 17 different countries, followed by an online consensus exercise with 12 participants in Northern Ireland. Consensus was reached to include five outcomes in the COS, comprising two main outcomes (‘The total number of antimicrobial courses prescribed’ and ‘Appropriateness of antimicrobial prescribing’) and three optional outcomes (‘Days of therapy per 1000 resident-days’, ‘Rate of antimicrobial resistance’, and ‘Mortality related to infection’). Following the COSMIN approach, 17 potential OMIs for the COS identified in literature searches were assessed for quality of measurement properties. Three OMIs with the best quality of evidence were presented in a consensus exercise with 59 Delphi panel members from 16 different countries. Ultimately, consensus was reached to select two OMIs for two outcomes ‘The total number of antimicrobial courses prescribed’ and ‘Days of therapy per 1000 resident-days’ in the COS. No OMIs were selected for the other outcomes in the COS. Conclusion: The research described in this thesis developed a COS for use in trials aimed at improving AMS in care homes. Future studies should use this COS to measure the effectiveness and safety of AMS interventions in care homes.

Introduction: Globally, population demographics are changing due to ageing. As people age, the prevalence of long-term conditions increases which gives rise to multimorbidity. Polypharmacy naturally accompanies multimorbidity and has many negative outcomes associated with it. When polypharmacy is prescribed appropriately, it is beneficial for the patient, leading to improved therapeutic outcomes. However, when polypharmacy is not prescribed appropriately, it can lead to potentially inappropriate prescribing (PIP). PIP occurs when the risk of an adverse event outweighs the intended clinical benefit of a medicine or when clinically indicated medicines are omitted. The overall aim of the research presented in this thesis was to explore potentially inappropriate prescribing (PIP) using a mixed methods approach. Methods: Both quantitative and qualitative methodology was used across the three studies contained in this thesis. The first study comprised a systematic review of the tools used to assess PIP in older adults (aged 365 years) who were receiving polypharmacy and aimed to identify the most appropriate tool for use in research based on a set of criteria deemed to be the key attributes that a tool to assess PIP should possess. The second study was quantitative in nature, using a unique linkage between the Enhanced Prescribing Database (EPD) and the Northern Ireland Longitudinal Study (NILS) to establish the prevalence of polypharmacy (dispensing of 4 or more medicines) and PIP in older adults living in Northern Ireland. In addition, this study determined the predictors for polypharmacy and PIP in both community-dwelling and care home residents and subsequently determined the relationship between polypharmacy, PIP and mortality in the two populations. Finally, a qualitative study, using a topic guide based on the Theoretical Domains Framework (TDF), was undertaken with pharmacists based in GP practices. Semi-structured interviews were conducted with practice-based pharmacists (PBPs) to explore the barriers and facilitators towards managing appropriate polypharmacy in older adults in primary care. Results: Based on the findings from the systematic review, the Screening Tool Of People’s Prescriptions (STOPP)/Screening Tool to Alert Right Treatment (START) criteria were determined to be the most appropriate tool to measure PIP in older adults who are receiving polypharmacy. Subsequently, in the second study in this thesis, a subset of the STOPP criteria were used to determine the prevalence of PIP in older adults, the factors associated with PIP and the relationship with mortality. This study revealed that both polypharmacy and PIP was highly prevalent among community-dwelling and care home residents, with the prevalence in the latter significantly higher even after adjustments for health. The majority of predictors for pharmacy and PIP were health-related factors with some residual associations remaining for socio-demographic factors e.g. female gender. Examples of PIP relating to the gastrointestinal (GI), central nervous system (CNS) and indication of medication categories were the most commonly encountered in both community-dwelling and care home residents. In community-dwelling population there was a modest association observed between polypharmacy, PIP and mortality, whereas in the care home population this relationship was not as clear. The qualitative study revealed that all TDF domains except ‘Emotion’ and ‘Nature of behaviours’, were either a barrier, facilitator or both, in managing appropriate polypharmacy in older adults. Pharmacists acknowledged their good professional relationships with GPs acted as a facilitator to managing appropriate polypharmacy, in addition to their clinical knowledge. Discussion and conclusion: The work contained in this thesis has added to the growing body of evidence on the use of screening tools to identify and assess PIP. Application of the screening tool highlighted the high prevalence of polypharmacy and PIP among older adults (aged 65 years or older). A particular concern was the high levels of both polypharmacy and PIP in care homes suggesting that there could be a prescribing culture within care homes in NI. Although pharmacists working in GP practices is a relatively new role in NI, they could contribute to a strategy to ensure polypharmacy is prescribed appropriately.

Introduction: Medication adherence is vital to ensuring optimal patient outcomes, particularly amongst older adults prescribed polypharmacy. However, complex interventions aimed at improving adherence have shown only limited effectiveness. To maximise effectiveness, the Medical Research Council (MRC) supports the use of both evidence and theory in developing interventions. Feasibility and pilot testing is then recommended to optimise interventions in advance of definitive trials. The aim of this research was to develop a novel complex intervention (using evidence and theory) to improve adherence in older adults (prescribed polypharmacy) and to test the feasibility of delivering this in community pharmacies. Methods: The presented research models the MRC complex intervention framework and focuses on development and feasibility testing phases. Firstly, a systematic review was conducted to address an identified evidence gap in relation to theory-based adherence interventions previously delivered to older adults prescribed polypharmacy. Qualitative research was then conducted to explore older patients’ adherence behaviour and identify determinants (barriers, facilitators) to target for change. Using the Theoretical Domains Framework (TDF) as a lens, key domains were selected for targeting and mapped to behaviour change techniques (BCTs) using established methods. These BCTs formed the basis of a complex intervention that was delivered to older patients by community pharmacists (CPs) as part of a small-scale feasibility study. In addition to exploring older patients’ adherence behaviours, further research focused on CPs’ clinical behaviour in relation to providing medication adherence support (MAS). The qualitative TDF-based methods used in the patient study were extended and a mixed methods (qualitative, quantitative) approach was used to identify determinants influencing CPs’ behaviour. Key target domains were identified and mapped to BCTs that could be directed at CPs (e.g. in a training package) to improve future implementation of the patient intervention. Results: The systematic review found that adherence interventions delivered to older patients prescribed polypharmacy were rarely based on theory, supporting the need for further research. The qualitative research conducted with older patients identified eight key domains (e.g. ‘Beliefs about consequences’, Memory, attention and decision process’) that could be targeted and these domains were mapped to 11 BCTs (e.g. ‘Prompts/cues’, ‘Self-monitoring’) which formed the basis of a complex intervention. The feasibility study demonstrated that the intervention was highly acceptable to both patients and CPs but some modifications were suggested. It also highlighted the need for additional research that focuses on CPs’ behaviour (i.e. MAS provision). Findings from the mixed methods study on CPs’ behaviour led to the identification of seven key domains that could be targeted for change (e.g. ‘Skills’, ‘Motivation and goals’). Eighteen BCTs were then selected for inclusion in a training package (e.g. ‘Demonstration of the behaviour’) or for delivery alongside the patient intervention in future research (e.g. ‘Rewards/incentives’) to improve implementation. Discussion/Conclusion: The MRC framework served as a useful guide for developing a complex intervention to improve adherence in older patients prescribed polypharmacy. This systematic theory-based approach that involved explicitly linking theoretical domains to intervention components (BCTs) will aid future replication and understanding of how the intervention aims to bring about behaviour change. Aside from targeting patients’ adherence behaviours, this research emphasised the importance of exploring the behaviours of intervention providers (i.e. CPs) to enhance implementation. Future research will involve pilot testing a refined version of the patient intervention and CP training package to establish if a definitive trial of effectiveness (e.g. randomised controlled trial) is warranted.