Why the trial researcher matters: Day-to-day work viewed through the lens of normalization process theory.

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.

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.

Terms used to describe and define activities undertaken as a result of the medication review process: Do they require standardisation? A systematic review.

BACKGROUND: Medication review (MR) is the systematic assessment of a patient's medications by a healthcare practitioner. It is necessary to compare such MR interventions to rationalise differences between them and assess their impact. The development of an international taxonomy for terms used to describe activities undertaken within the MR process would facilitate quality of reporting, and the comparison of different interventions. AIM: To identify overarching and individual MR activity terms and definitions reported within studies where MR was the main intervention. METHOD: A systematic review of the literature was performed using search terms for 'Intervention' and 'Outcome'. Papers with empirical data reporting and describing MR activities in English were included. The Mixed Method Appraisal Tool was used to assess research quality. Two researchers reviewed all included literature independently. Data extraction was performed using Cochrane Effective Practice and Organisation of Care to report study characteristics, and terms and definitions used to describe MR activities. RESULTS: Twenty-one papers were included: eight quantitative non-randomised trials (38%), eight randomised controlled trials (38%), and five quantitative descriptive studies (24%). Overarching interventions such as 'Clinical', 'Education' and 'Technical' were identified with no standardised definitions. Terms used to describe the medication review activities, such as stop, start and change, varied with significant potential for ambiguity. CONCLUSION: The literature reports a variety of overlapping, ambiguous and undefined MR terms. As a result, comparing process evaluations from MR interventions may be difficult. A standardised taxonomy to describe, define and report MR activities is required.

Contextual factors influencing medicines-related interventions to support safe transitions for care home residents post hospital discharge: a systematic review and meta-ethnographic synthesis.

BACKGROUND: Residents of care or nursing homes are at a higher risk of medication-related harm, especially during care transitions. No medicines-related intervention has been identified that supports the safe transition for these residents moving into their residence following hospital discharge. A model of care integrating a number of intervention components is suggested to be most effective AIM: To investigate, via a systematic review and meta-ethnography, the factors which influence the impact of medicines related interventions. METHOD: In December 2020, Pubmed, MEDLINE, EMBASE, PsycINFO, and CINAHL Complete were systematically searched. All studies reporting on medicines-related interventions for residents following hospital discharge were included. Quality assessment was undertaken with a validated tool. Meta-ethnography was used to investigate the factors which influenced how interventions did, or did not work. Findings were mapped to a validated conceptual framework for integrated care. RESULTS: From 3884 studies, nine met the inclusion criteria and were analysed. These were generally of medium quality (n = 6). The interventions were diverse: some tackled the transition process, some tackled follow-up care and some interventions involved both. The meta-ethnography, using the a priori conceptual framework, captured factors reported within the studies that influenced implementation, delivery and/or outcomes. CONCLUSION: The review and synthesis informed the development of a conceptual model for transitionary care for this population group. Researchers and decision-makers can use this as a tool to understand their local context and inform future intervention design, implementation and evaluation in this clinical area.

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.

Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE).

The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.

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.

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 ).

Longitudinal qualitative evaluation of pharmacist integration into the urgent care setting.

PURPOSE: To describe the most effective model for managing, educating, and training pharmacist advanced clinical practitioners (ACPs) in the urgent care center (UCC) setting, role evolution and how to measure their effectiveness. PARTICIPANTS AND METHODS: Ethical approval was obtained to perform a qualitative longitudinal cohort study in three sites, with three pharmacists in each trained as ACPs from 2016 to 2017. ACP role, location, management, mentorship, and supervision were locally determined. ACPs attended focus groups (FGs) at 1 and 3 months (sites 1-3), 6 and 12 months (site 1 only), and the UCC staff were interviewed once with a topic guide regarding training, integration, role, and impact. Verbatim transcriptions were analyzed thematically. RESULTS: Eight ACP FGs and 24 stakeholder interviews produced major themes of communication, management, education and training, role, and outcomes. Effective education, training, and integration required communication of role to address concerns regarding salary differentials, supportive management structure, and multi-professional learning. ACPs reported that the model of workplace training, experiential learning, and university-based education was appropriate. Training was better located in the minor injuries and general practitioner areas. Recommended measures of effectiveness included patient satisfaction and workload transfer. CONCLUSION: The education and training model was appropriate. Communication and management require careful consideration to ensure effective integration and role development. Pharmacists were better located initially in the minor illness rather than major trauma areas. Quality of patient experience resulting from the new role was important in addition to reassurance that the role represented a positive contribution to workload.

Identification of the benefits, enablers and barriers to integrating junior pharmacists into the ward team within one UK-based hospital.

INTRODUCTION: A high nurse-vacancy rate combined with high numbers of applications for junior pharmacist roles resulted in Colchester Hospital University National Health System Foundation Trust trial employing junior pharmacists into traditional nursing posts with the aim of integrating pharmacists into the ward team and enhancing local medicines optimization. The aim of the evaluation was to describe the implementation process and practice of the integrated care pharmacists (ICPs) in order to inform future innovations of a similar nature. METHODS: Four band 6 ward-based ICPs were employed on two wards funded within current ward staffing expenditure. With ethical committee approval, interviews were undertaken with the ICPs and focus groups with ward nurses, senior ward nurses and members of the medical team. Data were analyzed thematically to identify service benefits, barriers and enablers. Routine ward performance data were obtained from the two ICP wards and two wards selected as comparators. Appropriate statistical tests were performed to identify differences in performance. RESULTS: Four ICPs were interviewed, and focus groups were undertaken with three junior nurses, four senior nurses and three medical practitioners. Service enablers were continuous ward time, undertaking drug administration, positive feedback and use of effective communication methods. Barriers were planning, funding model, career development, and interprofessional working and social isolation. ICPs were believed to save nurse time and improve medicines safety. The proportion of patients receiving medicine reconciliation within 24 hours increased significantly in the ICP wards. All ICPs had resigned from their role within 12 months. DISCUSSION: It was believed that by locating pharmacists on the ward full time and allowing them to undertake medicines administration and medicines reconciliation, the nursing time would be saved and medicines safety improved. There was however significant learning to be derived from the implementation process, which may enable similar future models to be introduced more successfully.

Enclosing a pen reduced time to response to questionnaire mailings.

OBJECTIVES: To assess the effectiveness of including a pen in postal questionnaires on response rate, necessity of reminders, time to response, and completeness of response to the primary outcome question (POQ). STUDY DESIGN AND SETTING: A two-arm randomized controlled trial (RCT) embedded within the screening of older women for prevention of fracture trial (SCOOP). Women, aged 70-75 years, were randomized to receive a pen with their questionnaire (n = 3,826) or to receive the questionnaire alone (n = 3,829). The results were combined with another embedded RCT in a meta-analysis. RESULTS: A response rate of 92.4% was observed in the pen group compared with 91.3% in the control group (odds ratio [OR] = 1.16; 95% confidence interval [CI]: 0.98, 1.37; P = 0.08). There was a difference in reminders required (OR = 0.88; 95% CI: 0.79, 0.98; P = 0.02), time to response (hazard ratio = 1.06; 95% CI: 1.01, 1.11; P = 0.01) and some difference in the completeness of response to the POQ (OR = 1.18; 95% CI: 1.00, 1.39; P = 0.05). The pooled OR from the meta-analysis for response rate was 1.21 (95% CI: 1.05, 1.39; P = 0.01). CONCLUSION: Inclusion of a pen with postal questionnaires potentially has a positive impact on response rates and the number of reminders required. There may be some reduction in time to response. Studies of different participant groups are needed to test the effectiveness over more diverse populations.

Risk, significance and biomedicalisation of a new population: older women's experience of osteoporosis screening.

This article explores the illness experience associated with being diagnosed at risk of a long term chronic condition and discusses the implications of an emergent form of predictive medicine. We report on findings from a study involving 30 older women between the ages of 73-85 years of age recently screened for osteoporosis and informed that they are at a higher than average risk of breaking a bone in the next 10 years, but not formally diagnosed with osteoporosis. Data were gathered by the Adherence to Osteoporosis Medicine (ATOM) study using in-depth interviews with women in their own homes in Norfolk & Suffolk, UK in 2009-2010. We analyse and discuss the significance participants give to their new fracture risk status and consider the practical, physical and existential consequences of this 'diagnosis'. The findings are discussed under three broad themes: Predictive technology, meaning and the risk-of-illness experience; knowledge, understanding and the embodiment of fracture risk status; and, social implications of biomedicine for an ageing population. We argue that screening for osteoporosis and assessment of fracture risk can be understood as a process of biomedicalisation of ageing and bone health. This article offers insight into the meaning of risk status as an illness experience for older women. We conclude by discussing how biomedicalisation of a new population through diagnosis of fracture risk status has significance and consequence at both the individual and the societal level expanding the population of older women labelled at risk and increasing demand for biomedical tests and prescribed medication for the prevention of disease.