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Researchers working in the field, the places where research-relevant activity happens, are essential to recruitment and data collection in randomised controlled trials (RCTs). This study aimed to understand the nature of this often invisible work. Data were generated through an RCT of a pharmacist-led medication management service for older people in care homes. The study was conducted over three years and employed seven Research Associates (RA) working in Scotland, Northern Ireland, and England. Weekly research team meetings and Programme Management Group meetings naturally generated 129 sets of minutes. This documentary data was supplemented with two end-of-study RA debriefing meetings. Data were coded to sort the work being done in the field, then deductively explored through the lens of Normalization Process Theory to enable a greater understanding of the depth, breadth and complexity of work carried out by these trial delivery RAs. Results indicate RAs helped stakeholders and participants make sense of the research, they built relationships with participants to support retention, operationalised complex data collection procedures and reflected on their own work contexts to reach agreement on changes to trial procedures. The debrief discussions enabled RAs to explore and reflect on experiences from the field which had affected their day-to-day work. The learning from the challenges faced in facilitating care home research may be useful to inform future research team preparation for complex interventions. Scrutinising these data sources through the lens of NPT enabled us to identify RAs as linchpins in the successful conduct of a complex RCT study.

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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.

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The Northern Health and Social Care Trust developed an enhanced palliative care pharmacy service for acute inpatients within a large hospital in Northern Ireland during the initial COVID-19 surge. By training additional staff, there was an opportunity to increase service provision, utilising palliative care pharmacy skills to undertake activities such as the symptom management of patients, appropriate management of medicines, improved access to medicines, advice for other healthcare professionals, and supporting discharge from the hospital. The data collected showed a mean of 6.8 interventions per patient, and that, irrespective of the demand resulting from the COVID-19 pandemic, the palliative care pharmacy team had a role in improving the quality of care for palliative and end-of-life patients. Subsequent data analysis also demonstrated associated cost saving and the potential for the palliative care pharmacy team to reduce the length of stay at the hospital.

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Medicines optimisation for those with respiratory conditions can have a significant impact on clinical outcomes and substantial efficiency gains for health care. Consultant pharmacists are experts working at the top of their specialism in four main pillars of practice, namely clinical care, leadership, education and training, and research and development. A consultant respiratory pharmacist has recently been appointed at a large Health and Social Care Trust in Northern Ireland to provide expert care and clinical leadership for the medicines optimisation agenda with regards to respiratory care in Northern Ireland. Alongside clinical practice, leadership, and service development, emphasis will be placed on monitoring and evaluating the work of the consultant respiratory pharmacist with a view to gathering the necessary evidence to support the case for further investment in such consultant pharmacist posts in the region. This short communication article outlines some of the clinical and economic factors associated with the decisions to invest in the consultant pharmacist model of care in Northern Ireland.

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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 ).

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People generally need more support as they grow older to maintain healthy and active lifestyles. Older people living with chronic conditions are particularly dependent on healthcare services. Yet, in an increasingly digital society, there is a danger that efforts to drive innovations in eHealth will neglect the needs of those who depend on healthcare the most-our ageing population. The SHAPES (Smart and Healthy Ageing through People Engaging in Supportive Systems) Innovation Action aims to create an open European digital platform that facilitates the provision of meaningful, holistic support to older people living independently. A pan-European pilot campaign will evaluate a catalogue of digital solutions hosted on the platform that have been specifically adapted for older people. 'Medicines control and optimisation' is one of seven themes being explored in the campaign and will investigate the impact of digital solutions that aim to optimise medicines use by way of fostering effective self-management, while facilitating timely intervention by clinicians based on remote monitoring and individualised risk assessments powered by artificial intelligence. If successful, the SHAPES Innovation Action will lead to a greater sense of self-sufficiency and empowerment in people living with chronic conditions as they grow older.

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Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1-3 = 'of limited importance'; 4-6 = 'important, but not critical'; and 7-9 = 'critical'. Outcomes rated 'critical' by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.

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Background Polypharmacy is associated with an increased risk of adverse drug events, inappropriate prescribing and medication errors. People with bronchiectasis have frequent pulmonary exacerbations that require antibiotic therapy. Objective This study aimed to measure polypharmacy and medication regimen complexity in bronchiectasis patients and to explore associations between these factors and oral and intravenous (IV) antibiotic use for suspected pulmonary exacerbations. Setting Patients were sampled from the Regional Bronchiectasis Clinic at the Belfast Health and Social Care Trust, Northern Ireland. Method Data on medicines were collected from patients' records and used to measure polypharmacy using three thresholds (≥ 4, ≥ 10, and ≥ 15 medicines'). Medication regimen complexity was calculated using the medication regimen complexity index (MRCI). Data analysis investigated differences in outcomes across polypharmacy thresholds and correlations with MRCI. Main outcome measure Primary outcomes were prescriptions for oral antibiotics and IV antibiotics, in the past 6 months and 2 years, respectively. Results Over three-quarters of the sample (N = 95) were prescribed ≥ 4 medicines (n = 74; 77.9%), 31 patients were prescribed ≥ 10 medicines (33.0%), and 12 patients (12.8%) were prescribed ≥ 15 medicines. The median MRCI was 26. Patients prescribed ≥ 10 medicines were over three times more likely to have had an IV antibiotic in the past 2 years (adjusted odd ratio 3.44, 95% confidence intervals 1.15-10.31). Conclusion There were significant differences in all outcomes across the '≥ 10 medicines' threshold. MRCI was positively correlated with oral and IV antibiotic usage. These findings also suggest a possible link between polypharmacy and medicines regimen complexity, and poorer outcomes.

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