Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study.

BACKGROUND: People experiencing homelessness (PEH) have complex health and social care needs and most die in their early 40 s. PEH frequently use community pharmacies; however, evaluation of the delivery of structured, integrated, holistic health and social care intervention has not been previously undertaken in community pharmacies for PEH. PHOENIx (Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx) has been delivered and tested in Glasgow, Scotland, by NHS pharmacist independent prescribers and third sector homelessness support workers offering health and social care intervention in low threshold homeless drop-in venues, emergency accommodation and emergency departments, to PEH. Building on this work, this study aims to test recruitment, retention, intervention adherence and fidelity of community pharmacy-based PHOENIx intervention. METHODS: Randomised, multi-centre, open, parallel-group external pilot trial. A total of 100 PEH aged 18 years and over will be recruited from community pharmacies in Glasgow and Birmingham. PHOENIx intervention includes structured assessment in the community pharmacy of health, housing, benefits and activities, in addition to usual care, through weekly visits lasting up to six months. A primary outcome is whether to proceed to a definitive trial based on pre-specified progression criteria. Secondary outcomes include drug/alcohol treatment uptake and treatment retention; overdose rates; mortality and time to death; prison/criminal justice encounters; healthcare utilisation; housing tenure; patient-reported measures and intervention acceptability. Analysis will include descriptive statistics of recruitment and retention rates. Process evaluation will be conducted using Normalisation Process Theory. Health, social care and personal resource use data will be identified, measured and valued. DISCUSSION: If the findings of this pilot study suggest progression to a definitive trial, and if the definitive trial offers positive outcomes, it is intended that PHOENIx will be a publicly funded free-to-access service in community pharmacy for PEH. The study results will be shared with wider stakeholders and patients in addition to dissemination through medical journals and scientific conferences. TRIAL REGISTRATION: International Clinical Trial Registration ISRCTN88146807. Approved protocol version 2.0 dated July 19, 2022.

Benign ethnic neutropenia: an analysis of prevalence, timing and identification accuracy in two large inner-city NHS hospitals.

BACKGROUND: Benign ethnic neutropenia (BEN) is the most common cause of chronic neutropenia seen in individuals of African, Middle Eastern and West Indian descent. This phenotype is broadly defined by an absolute neutrophil counts (ANC) below 1.8 × 109 cells/L in the absence of other causes, without an increased risk of infection. BEN has been implicated as a potential source of disparity in patients treated with clozapine, the antipsychotic of choice in treatment-resistant schizophrenia. Our main objective was to examine the current level of BEN recognition in a cohort of patients treated with clozapine and the potential impact of unidentified BEN on the initiation and maintenance of clozapine treatment. METHODS: This was an observational, retrospective analysis of patients registered with clozapine haematological monitoring systems in two large mental health trusts, chosen because they serve an ethnically diverse population. The first objective was to establish certified BEN prevalence in current users of clozapine. The second objective was to explore the stage of treatment at which BEN was identified. The third objective was to evaluate the extent of unrecognised BEN in patients registered on the Central Non-Rechallenge Database (CNRD), a database for patients whose haematological parameters fall below set thresholds when receiving clozapine treatment, meaning they cannot ordinarily be prescribed clozapine again. RESULTS: The study population comprised of 2020 patients on the clozapine register. 111 patients were monitored under BEN criteria. BEN was mostly identified after a below threshold haematological result or clozapine rechallenge (68%) compared to at clozapine initiation (32%). Eight of the 18 (42%) black patients registered on the CNRD were classified as BEN after assessment by a haematologist. Of these 8 patients, none would have met CNRD criteria again if monitored with BEN criteria at clozapine initiation. CONCLUSIONS: Current evidence suggests that BEN remains an uncommonly recognised haematological phenotype. Improved timely identification of BEN will reduce unnecessary interruption or discontinuation of clozapine treatment. Our results suggest consideration should also be given to determining BEN status prior to initiating clozapine. Moreover, adoption of current FDA BEN monitoring criteria in the UK may further reduce clozapine discontinuation due to perceived neutropenia as drug toxicity, particularly in treatment-refractory schizophrenia patients.

Research priorities in healthcare of persons experiencing homelessness: outcomes of a national multi-disciplinary stakeholder discussion in the United Kingdom.

BACKGROUND: Persons experiencing homelessness (PEH) face up to twelve times higher mortality rates compared to the general population. There is a need to develop, evaluate and implement novel interventions to minimise such inequalities. This paper aims to present outcomes of a national stakeholder engagement event that was conducted to discuss research priorities around healthcare of PEH in the United Kingdom (UK). MAIN BODY: A national stakeholder event was organised in Birmingham, UK. This workshop aimed to engage diverse stakeholders from a variety of background including representations from clinical practice, substance misuse, anti-slavery network, public health practice, local authority, homelessness charities, drugs and alcohol services, Public Health England and academia. A total of five key priority areas for research were identified which included: a) interventions to improve access to health services and preventative services; b) interventions to prevent drug and alcohol related deaths; c) improving existing services through quality improvement; d) identifying PEH's preferences of services; and e) interventions to break the link between vulnerabilities, particularly- modern day slavery and homelessness. Effective partnerships across diverse stakeholder groups were deemed to be imperative in developing, testing and implementing novel interventions. CONCLUSIONS: Maximising access to services, prevention of early deaths linked to drugs and alcohol, and identifying effective and ineffective policies and programmes were identified as priority research areas in relation to healthcare of PEH. The outcomes of this discussion will enable design and conduct of interdisciplinary research programmes to address the syndemics of homelessness and linked adverse health outcomes. Priorities identified here are likely to be applicable internationally.

MEDREV (pharmacy-health psychology intervention in people living with dementia with behaviour that challenges): the feasibility of measuring clinical outcomes and costs of the intervention.

BACKGROUND: People living with dementia in care homes frequently exhibit "behaviour that challenges". Anti-psychotics are used to treat such behaviour, but are associated with significant morbidity. This study researched the feasibility of conducting a trial of a full clinical medication review for care home residents with behaviour that challenges, combined with staff training. This paper focusses on the feasibility of measuring clinical outcomes and intervention costs. METHODS: People living with moderate to severe dementia, receiving psychotropics for behaviour that challenges, in care homes were recruited for a medication review by a specialist pharmacist. Care home and primary care staff received training on the management of challenging behaviour. Data were collected at 8 weeks, and 3 and 6 months. Measures were Neuropsychiatric Inventory-Nursing Home version (NPI-NH), cognition (sMMSE), quality of life (EQ-5D-5 L/DEMQoL) and costs (Client Services Receipt Inventory). Response rates, for clinical, quality of life and health economic measures, including the levels of resource-use associated with the medication review and other non-intervention costs were calculated. RESULTS: Twenty-nine of 34 participants recruited received a medication review. It was feasible to measure the effects of the complex intervention on the management of behaviour that challenges with the NPI-NH. There was valid NPI-NH data at each time point (response rate = 100%). The sMMSE response rate was 18.2%. Levels of resource-use associated with the medication review were estimated for all 29 participants who received a medication review. Good response levels were achieved for other non-intervention costs (100% completion rate), and the EQ-5D-5 L and DEMQoL (≥88% at each of the time points where data was collected). CONCLUSIONS: It is feasible to measure the clinical and cost effectiveness of a complex intervention for behaviour that challenges using the NPI-NH and quality of life measures. TRIAL REGISTRATION: ISRCTN58330068. Retrospectively registered, 15 October 2017.

Clinical Pharmacy Intervention for Persons Experiencing Homelessness: Evaluation of Patient Perspectives in Service Design and Development.

Persons experiencing homelessness have a high prevalence of severe mental health problems, alcohol dependence, substance misuse and infectious hepatitis C, and face up to twelve times higher mortality rates compared to the general population. They also face barriers to accessing healthcare. However, clinical pharmacy services are currently not available to homeless populations in England. The aim of this study was to conduct public involvement sessions with persons experiencing homelessness with a view to inform the design of patient-centred clinical pharmacy healthcare services. Qualitative methodology was used, using a focus group with homeless persons from emergency shelters and one to one engagement with those sleeping rough, using a topic guide. A total of nine homeless persons took part-seven males and two females. The participants of the sessions said that patient-centred clinical pharmacy services delivered for homeless persons would address many of their unmet needs around access to medicines, their understanding of prescribed medicines and holistic management of their health. The service would be able to make a positive impact on their health outcomes by screening for health conditions, facilitating better integration across services, referral and liaison with other services, and minimising misuse of prescribed medicines. The findings of this study will be used to inform the development, implementation and evaluation of a patient-centred clinical pharmacy service tailored to meet the specific needs of the homeless population.

Medication review plus person-centred care: a feasibility study of a pharmacy-health psychology dual intervention to improve care for people living with dementia.

BACKGROUND: "Behaviour that Challenges" is common in people living with dementia, resident in care homes and historically has been treated with anti-psychotics. However, such usage is associated with 1800 potentially avoidable deaths annually in the UK. This study investigated the feasibility of a full clinical trial of a specialist dementia care pharmacist medication review combined with a health psychology intervention for care staff to limit the use of psychotropics. This paper focuses on feasibility; including recruitment and retention, implementation of medication change recommendations and the experiences and expectations of care staff. METHODS: West Midlands care homes and individuals meeting the inclusion criteria (dementia diagnosis; medication for behaviour that challenges), or their personal consultee, were approached for consent. A specialist pharmacist reviewed medication. Care home staff received an educational behaviour change intervention in a three-hour session promoting person-centred care. Primary healthcare staff received a modified version of the training. The primary outcome measure was the Neuropsychiatric Inventory-Nursing Home version at 3 months. Other outcomes included quality of life, cognition, health economics and prescribed medication. A qualitative evaluation explored expectations and experiences of care staff. RESULTS: Five care homes and 34 of 108 eligible residents (31.5%) were recruited, against an original target of 45 residents across 6 care homes. Medication reviews were conducted for 29 study participants (85.3%) and the pharmacist recommended stopping or reviewing medication in 21 cases (72.4%). Of the recommendations made, 57.1% (12 of 21) were implemented, and implementation (discontinuation) took a mean of 98.4 days. In total, 164 care staff received training and 21 were interviewed. Care staff reported a positive experience of the intervention and post intervention adopting a more holistic patient-centred approach. CONCLUSIONS: The intervention contained two elements; staff training and medication review. It was feasible to implement the staff training, and the training appeared to increase the ability and confidence of care staff to manage behaviour that challenges without the need for medication. The medication review would require significant modification for full trial partly related to the relatively limited uptake of the recommendations made, and delay in implementation. TRIAL REGISTRATION: ISRCTN58330068 . Registered 15 October 2017. Retrospectively registered.

Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy-health psychology intervention feasibility study.

INTRODUCTION: The inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to other equally dangerous psychotropics. Little is known about the role of pharmacists in the management of psychotropics used to treat behaviours that challenge. This research aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy-health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in care home residents with dementia. METHODS/ANALYSIS: 6 care homes within the West Midlands will be recruited. People with dementia receiving medication for behaviour that challenges, or their personal consultee, will be approached regarding participation. Medication used to treat behaviour that challenges will be reviewed by the pharmacist, in collaboration with the general practitioner (GP), person with dementia and carer. The behavioural intervention consists of a training package for care home staff and GPs promoting person-centred care and treating behaviours that challenge as an expression of unmet need. The primary outcome measure is the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Other outcomes include quality of life (EQ-5D and DEMQoL), cognition (sMMSE), health economic (CSRI) and prescribed medication including whether recommendations were implemented. Outcome data will be collected at 6 weeks, and 3 and 6 months. Pretraining and post-training interviews will explore stakeholders' expectations and experiences of the intervention. Data will be used to estimate the sample size for a definitive study. ETHICS/DISSEMINATION: The project has received a favourable opinion from the East Midlands REC (15/EM/3014). If potential participants lack capacity, a personal consultee will be consulted regarding participation in line with the Mental Capacity Act. Results will be published in peer-reviewed journals and presented at conferences.

Liverpool Telecare Pilot: case studies.

Telecare services use information and communications technology (ICT) to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK) City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.