Cost and economic evidence for asset-based approaches to health improvement and their evaluation methods: a systematic review.

BACKGROUND: Asset-based approaches (ABAs) tackle health inequalities by empowering people in more disadvantaged communities, or targeted populations, to better utilise pre-existing local community-based resources. Using existing resources supports individuals to better manage their own health and its determinants, potentially at low cost. Targeting individuals disengaged with traditional service delivery methods offers further potential for meaningful cost-savings, since these people often require costly care. Thus, improving prevention, and management, of ill-health in these groups may have considerable cost implications. AIM: To systematically review the extent of current cost and economic evidence on ABAs, and methods used to develop it. METHODS: Search strategy terms encompassed: i) costing; ii) intervention detail; and iii) locality. Databases searched: Medline, CENTRAL and Wed of Science. Researchers screened 9,116 articles. Risk of bias was assessed using the Critical Appraisal Skills Programme (CASP) tool. Narrative synthesis summarised findings. RESULTS: Twelve papers met inclusion criteria, representing eleven different ABAs. Within studies, methods varied widely, not only in design and comparators, but also in terms of included costs and outcome measures. Studies suggested economic efficiency, but lack of suitable comparators made more definitive conclusions difficult. CONCLUSION: Economic evidence around ABAs is limited. ABAs may be a promising way to engage underserved or minority groups, that may have lower net costs compared to alternative health and wellbeing improvement approaches. ABAs, an example of embedded services, suffer in the context of economic evaluation, which typically consider services as mutually exclusive alternatives. Economics of the surrounding services, mechanisms of information sharing, and collaboration underpin the success of assets and ABAs. The economic evidence, and evaluations in general, would benefit from increased context and detail to help ensure more nuanced and sophisticated understanding of the economics of ABAs. Further evidence is needed to reach conclusions about cost-effectiveness of ABAs.

Protocol for a realist evaluation of Recovery College dementia courses: understanding coproduction through ethnography.

INTRODUCTION: Support following a dementia diagnosis in the UK is variable. Attending a Recovery College course with and for people with dementia, their supporters and healthcare professionals (staff), may enable people to explore and enact ways to live well with dementia. Recovery Colleges are established within mental health services worldwide, offering peer-supported short courses coproduced in partnership between staff and people with lived experience of mental illness. The concept of recovery is challenging in dementia narratives, with little evidence of how the Recovery College model could work as a method of postdiagnostic dementia support. METHODS AND ANALYSIS: Using a realist evaluation approach, this research will examine and define what works, for whom, in what circumstances and why, in Recovery College dementia courses. The ethnographic study will recruit five case studies from National Health Service Mental Health Trusts across England. Sampling will seek diversity in new or long-standing courses, delivery methods and demographics of population served. Participant observations will examine course coproduction. Interviews will be undertaken with people with dementia, family and friend supporters and staff involved in coproducing and commissioning the courses, as well as people attending. Documentary materials will be reviewed. Analysis will use a realist logic of analysis to develop a programme theory containing causal explanations for outcomes, in the form of context-mechanism-outcome-configurations, at play in each case. ETHICS AND DISSEMINATION: The study received approval from Coventry & Warwickshire Research Ethics Committee (22/WM/0215). Ethical concerns include not privileging any voice, consent for embedded observational fieldwork with people who may experience fluctuating mental capacity and balancing researcher 'embedded participant' roles in publicly accessible learning events. Drawing on the realist programme theory, two stakeholder groups, one people living with dementia and one staff will work with researchers to coproduce resources to support coproducing Recovery College dementia courses aligned with postdiagnostic services.

What happens when pharmacist independent prescribers lead on medicine management in older people's care homes: a qualitative study.

OBJECTIVE: Older people in care homes frequently experience polypharmacy, increasing the likelihood of medicine-related burden. Pharmacists working within multidisciplinary primary care teams are ideally placed to lead on medication reviews. A randomised controlled trial placed pharmacists, with independent prescribing rights (PIPs), into older people care homes. In the intervention service, PIPs worked with general practitioners (GPs) and care home staff for 6 months, to optimise medicine management at individual resident and care home level. PIP activity included stopping medicines that were no longer needed or where potential harms outweighed benefits. This analysis of qualitative data examines health and social care stakeholders' perceptions of how the service impacted on care home medicine procedures and resident well-being. DESIGN: Pragmatic research design with secondary analysis of interviews. SETTING: Primary care pharmacist intervention in older people care homes in England, Scotland and Northern Ireland. PARTICIPANTS: Recruited from intervention arm of the trial: PIPs (n=14), GPs (n=8), care home managers (n=9) and care home staff (n=6). RESULTS: There were resonances between different participant groups about potential benefits to care home residents of a medicine service provided by PIPs. There were small differences in perceptions about changes related to communication between professionals. Results are reported through three themes (1) 'It's a natural fit'-pharmacists undertaking medication review in care homes fitted within multidisciplinary care; (2) 'The resident is cared for'-there were subjective improvements in residents' well-being; (3) 'Moving from "firefighting" to effective systems'-there was evidence of changes to care home medicine procedures. CONCLUSION: This study suggests that pharmacist independent prescribers in primary care working within the multidisciplinary team can manage care home residents' medicines leading to subjective improvements in residents' well-being and medicine management procedures. Care home staff appreciated contact with a dedicated person in the GP practice. TRIAL REGISTRATION: ISRCTN 17847169.

Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare).

BACKGROUND: Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention's mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. METHODS/DESIGN: A mixed method process evaluation to inform the interpretation of trial findings. OBJECTIVES: • Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. DISCUSSION: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. TRIAL REGISTRATION: ISRCTN ISRCTN22729870. Registered on 24 August 2022.

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.

"The Dynamic Nature of Being a Person": An Ethnographic Study of People Living With Dementia in Their Communities.

BACKGROUND AND OBJECTIVES: A dementia diagnosis can affect social interactions. This study aims to understand how people living with dementia act as social beings within everyday interactions in their local communities. RESEARCH DESIGN AND METHODS: Focused ethnography informed by Spradley's approach to data collection and analysis. Observations in community spaces. RESULTS: Twenty-nine observations were undertaken in everyday social settings with 11 people with dementia who were part of a longitudinal interview study. Data consisted of 40 hr of observation, and researcher field notes. The overarching theme "the dynamic nature of being a person" encapsulates participants' exhibited experiences in negotiating to attain and sustain an acknowledged place in their communities. Two subthemes characterized contexts and actions: (1) "Being me-not dementia": Participants constructed narratives to assert their ontological presence in social settings. They and others used strategies to mediate cognitive changes evidencing dementia. (2) "Resisting or acquiescing to 'being absent in place'": Participants were often able to resist being absent to the gaze from others, but some social structures and behaviors led to a person being "in place," yet not having their presence confirmed. DISCUSSION AND IMPLICATIONS: People living with dementia can actively draw on personal attributes, familiar rituals, objects, and social roles to continue to present themselves as social beings. Identifying how postdiagnosis people may self-manage cognitive changes to retain their presence as a person can help health and social care practitioners and families collaborate with the person living with dementia enabling them to have a continued social presence.

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.

Barriers and enablers to deprescribing for older people in care homes: The theory-based perspectives of pharmacist independent prescribers.

BACKGROUND: Over 70% of care home residents are prescribed potentially inappropriate medications (PIMs) associated with morbidity and mortality. Deprescribing is a common recommendation by pharmacists performing medication reviews in care homes, however requiring prescriber authorisation is a barrier. Care home Independent Pharmacist Prescribing Study (CHIPPS), a cluster randomised control trial integrated pharmacist independent prescriber (PIPs) into care homes to improve medication management, providing a unique opportunity to identify their barriers and enablers to deprescribing. OBJECTIVES: To identify barriers and enablers to PIPs deprescribing medications in care homes. METHODS: Secondary qualitative framework analysis was performed on interviews with CHIPPS' PIPs. A maximum variation sampling approach was used to select from the 14 PIPs included in the process evaluation to achieve diversity of PIPs' contextual factors e.g., previous experience in care homes. Transcripts were coded inductively for barriers and enablers to deprescribing and then mapped to Theoretical Domains Framework (TDF). RESULTS: Eleven PIP's interviews were sampled. Factors acted as enablers and barriers were PIP relationship with General Practitioner (GP), care home staff and residents/families, awareness of the PIP role and family trust in PIPs' deprescribing activities (social influences); PIPs' independent prescribing confidence, previous experience and ability dealing with residents' medications (beliefs about capabilities); understanding of PIP role and PIP confidence in their role as an independent prescriber (Social/professional role and identity); access to residents' records, deprescribing decision support, regular follow-up from care home staff, resident difficulties with medications, teamwork, and time restraints (Environmental context and resources). One factor acted as a barrier: believing negatives of deprescribing outweigh benefits regarding certain medications (Beliefs about consequences). CONCLUSION: PIPs' involvement in deprescribing within care homes is influenced by multiple barriers and enablers. Data mapped to TDF domains represent barriers that need addressing and enablers that should be highlighted to enhance PIPs' effectiveness in future interventions.

Hospital clinicians' perspectives of using compression therapy on venous leg ulcers: a systematic qualitative review.

Venous leg ulcer treatment is frequently discontinued in hospitals in contravention of national guidance, significantly affecting patient outcomes and increasing NHS costs. AIM: To identify, from the published literature, reasons for variable implementation. METHOD: Systematic review with narrative synthesis, including full papers in English with empirical qualitative data. Synonyms for venous leg ulcer, compression therapy and secondary care were searched across a range of health-related databases. The Critical Appraisal Skills Programme (CASP) checklist determined study quality, and meta-ethnography was used for data synthesis. RESULTS: 7040 titles and abstracts and 41 full-text papers were screened with four papers selected. Three key themes were generated: educational needs surrounding implementation of compression therapy, patient factors regarding adherence and organisational resources including availability of appropriate equipment and trained staff. CONCLUSION: Barriers at the ward level were identified. There is a need to better understand why hospitals are not addressing them.

Care-home Nurses' responses to the COVID-19 pandemic: Managing ethical conundrums at personal cost: A qualitative study.

INTRODUCTION: The COVID-19 pandemic had an unprecedented effect on those living and working in care-homes for older people, as residents were particularly vulnerable to contracting the SARS-CoV-2 virus, associated with high morbidity and mortality. Often undervalued, care-home nurses (RNs) are leaders, managing complex care while working in isolation from their professional peers. The pandemic made this more apparent, when care and treatments for COVID-19 were initially unknown, isolation increased due to withdrawal of many professional health services, accompanied by staff shortages. OBJECTIVE: To explore RNs' experiences of working in older people's care-homes during the COVID-19 pandemic. DESIGN: Qualitative interview study. SETTING: Care-homes for older people in England and Scotland, UK. METHODS: Recruitment via direct contact with care-homes, social media, and links provided by national partners, then purposive sampling for age, gender, type of care-home, and location. Data collected through one-to-one online interviews using topic guide developed collaboratively with care-home nurses, focusing on how COVID-19 impacted on nurses' resilience and mental wellbeing. Data analyzed thematically using Tronto's ethics of care framework to guide development of interpretative themes. RESULTS: Eighteen nurses (16 female; 16 adult, and two mental health nurses) were interviewed March-June 2021; majority aged 46-55 years; mean time registered with Nursing and Midwifery Council: 19 years; 17 had nursed residents with COVID-19. RNs' experiences resonated with Tronto's five tenets of ethical care: attentiveness, responsibility, competence, responsiveness, and solidarity. All nurses described being attentive to needs of others, but were less attentive to their own needs, which came at personal cost. RNs were aware of their professional and leadership responsibilities, being as responsive as they could be to resident needs, processing and sharing rapidly changing guidance and implementing appropriate infection control measures, but felt that relatives and regulatory bodies were not always appreciative. RNs developed enhanced clinical skills, increasing their professional standing, but reported having to compromise care, leading to moral distress. Broadly, participants reported a sense of solidarity across care-home staff and working together to cope with the crisis. CONCLUSION: Care-home nurses felt unprepared for managing the COVID-19 pandemic, many experienced moral distress. Supporting care-home nurses to recover from the pandemic is essential to maintain a healthy, stable workforce and needs to be specific to care-home RNs, recognizing their unique pandemic experiences. Support for RNs will likely benefit other care-home workers either directly through wider roll-out, or indirectly through improved wellbeing of nurse leaders. CLINICAL RELEVANCE: The COVID-19 pandemic, an international public health emergency, created many challenges for Registered Nurses (RNs) working in long-term care facilities for older people, as residents were particularly vulnerable to the impact of the SARS-CoV-2 virus. Care-home RNs faced challenges distinct from their hospital-based nursing peers and non-nursing social care colleagues due to their isolation, leadership roles, professional legal obligations, and ethical responsibilities, leading to psychological distress on the one hand, but also a newly found confidence in their existing and newly developed skills, and increased recognition by the wider health community of their specialisms.

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.

A Case Study of Co-production Within a Mental Health Recovery College Dementia Course: Perspectives of A Person With Dementia, Their Family Supporter and Mental Health Staff.

Background: Undertaking co-production as a power-sharing way to improve mental health dementia services remains uncommon, suggesting opportunities to apply knowledge from lived experience of people with dementia, may often be missed. One barrier is stigma, assuming people with progressive cognitive impairment cannot manage this level of participation, support peers nor offer a "valid" perspective. Purpose: This paper shares knowledge gained from a service evaluation that explored various experiences of a person with dementia, their family supporter and mental health staff, involved in co-producing a course about "living well" with dementia, within a mental health Recovery College. Design: A qualitative, case study approach used semi-structured interviewing and inductive thematic analysis. Findings: Co-production activities generated a shared sense of positivity, pride and privilege, highlighting positive effects in breaking down the "them and us" barriers common in traditional healthcare professional-service user relationships. Each individual had both something to offer and something to gain during the process. Staff identified challenges in the co-production process; in that balancing all the voices during meetings could be complex at times, and the process overall required considerable time commitment. Conclusion: Taking part in co-production at an appropriate level and with peer support is a relational activity seen to be valuable in powerfully, yet gently, challenging stigma and assumptions around dementia. Findings show that while the process of co-production requires time and dedication, there is overall value in involving people living with dementia both in co-production and in peer support. This provided a straightforward and beneficial means to inclusively improve post-diagnosis support and care quality within a memory service.

Embedding patient and public involvement in dementia research: Reflections from experiences during the 'Journeying through Dementia' randomised controlled trial.

BACKGROUND: The involvement of people with a diagnosis of dementia in patient and public involvement and engagement (PPIE) in research is an emerging field in the delivery of studies. Researchers need to understand and use the learning derived from various projects so that this growing body of knowledge can be applied in future research. OBJECTIVE: To embed PPIE throughout a randomised controlled trial of a psychosocial intervention called Journeying through Dementia. We identify and discuss the approaches to involvement that worked well and those where improvements were indicated. DESIGN: The Guidance for Reporting Involvement of Patients and the Public Short Form (GRIPP2-SF) is used to describe and critically appraise the approaches taken and the impact of PPIE involvement upon study processes, the study team and those people with dementia and their supporters who acted as advisors. FINDINGS: The involvement of people with a diagnosis of dementia and supporters as study advisors improved the accessibility and relevance of the research for people living with dementia. It also highlighted issues that researchers may have otherwise overlooked. Successful engagement of people with dementia and their supporters in the study was associated with staff skills and particularly use of techniques to scaffold meaningful involvement, as well as participants' memory and cognitive capacity. However, embedding robust and meaningful involvement processes required significant time and resources. DISCUSSION: We propose that certain research processes need to be adapted to be accessible and appropriate for people living with dementia. Recruitment of PPIE advisors needs to reflect population diversity. There also needs to be greater parity of voice between people with lived experience of dementia and researchers. These steps will increase the impact of PPIE in research and improve the experience for those who volunteer to be PPIE advisors.

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 ).

Impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases in the UK: a mixed-methods study.

OBJECTIVES: To determine the impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases (RMDs) and to explore how people adapted to these measures over time. DESIGN: Mixed-methods investigation comprising a national online longitudinal survey and embedded qualitative study. SETTING: UK online survey and interviews with community-dwelling individuals in the East of England. PARTICIPANTS: People in the UK with RMDs were invited to participate in an online survey. A subsection of respondents were invited to participate in the embedded qualitative study. PRIMARY AND SECONDARY OUTCOME MEASURES: The online survey, completed fortnightly over 10 weeks from April 2020 to August 2020, investigated changes in symptoms, social isolation and loneliness, resilience and optimism. Qualitative interviews were undertaken assessing participant's perspectives on changes in symptoms, exercising, managing instrumental tasks such a shopping, medication and treatment regimens and how they experienced changes in their social networks. RESULTS: 703 people with RMDs completed the online survey. These people frequently reported a deterioration in symptoms as a result of COVID-19 pandemic social restrictions (52% reported increase vs 6% reported a decrease). This was significantly worse for those aged 18-60 years compared with older participants (p=0.017). The qualitative findings from 26 individuals with RMDs suggest that the greatest change in daily life was experienced by those in employment. Although some retired people reported reduced opportunity for exercise outside their homes, they did not face the many competing demands experienced by employed people and people with children at home. CONCLUSIONS: People with RMDs reported a deterioration in symptoms when COVID-19 pandemic social restriction measures were enforced. This was worse for working-aged people. Consideration of this at-risk group, specifically for the promotion of physical activity, changing home-working practices and awareness of healthcare provision is important, as social restrictions continue in the UK.

Feasibility and acceptability evaluation of the Promoting Independence in Dementia (PRIDE) intervention for living well with dementia.

OBJECTIVES: Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this. METHOD: The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators. RESULTS: Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators. CONCLUSIONS: The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.

Exploring disconnected discourses about Patient and Public Involvement and Volunteer Involvement in English health and social care.

BACKGROUND: Patient and public involvement (PPI) in health and social care policy, service decision-making and research are presented as good practice in England. Yet the explicit rationale for PPI and how it is positioned within the literature, policy and practice remain confused, in particular, in relation to Volunteer Involvement (VI). In health and social care, PPI and VI are managed and valued as conceptually distinct, yet the discourses in their policy and practice documents treat them as closely related in fundamental ways. OBJECTIVE: Compare and critically evaluate discourses framing PPI and VI within English health and social care. DESIGN: A critical discourse approach was used to explore the accounts of PPI and VI in policy. These accounts were then compared and contrasted with personal accounts of volunteering in health and social care settings. RESULTS: Twenty documents from key national health and social care bodies were discursively examined in terms of their framing PPI and VI. A narrative disconnect between the two was repeatedly confirmed. This finding contrasted with an analysis of personal accounts of VI which displayed VI as a form of PPI. CONCLUSION: There is a disconnect between language, narratives and practice in PPI and in VI which may have direct consequences for policy and practice. Recognising and managing it can offer innovative ways of enabling volunteers to be involved across health and social care settings, ensuring the experiential value added by volunteers' service contributions, to be recognised so that their democratic participation may be seen to shape services.