A cluster randomised controlled trial of Pharmacist-led Statin Outreach Support in Primary Care

Summary Background Elevated blood lipids (particularly cholesterol and sub-fractions) contribute to the risk of developing cerebral, peripheral and cardiovascular disease and associated complications which are leading causes of morbidity and death. Statins reduce the risk of suffering vascular events, with or without decreasing cholesterol levels. Statin prescribing continues to increase but there is scope to improve prescribing and dosing, particularly in primary care. However, there is insufficient empirical evidence to inform approaches to quality improvement. Methods Following pilot work, we designed a new model of primary care based pharmacist-led intervention for General Practitioners (GPs) and nurses. The aim of the intervention (called Statin Outreach Support, SOS) was to improve statin prescribing by GPs, in line with recent evidence, targeting patients at highest risk of suffering a vascular event. Eleven trained pharmacists worked in SOS allocated practices one day per week for a year. During this period, the pharmacist met three times with all GPs, all nurses and other practice staff. Between meetings, pharmacists used patient level clinical and prescribing data to identify eligible patients and help practices initiate, up-titrate the dose or switch to simvastatin 40mg where indicated. The effectiveness of SOS was tested in a prospective single blind cluster randomised controlled trial. Usual care (UC) practices received no pharmacist support during the study. With a mean of 1.7 years follow up, the study had over 90% power (at 5% significance) to detect a difference of 12% in the proportion of patients with controlled cholesterol after practices had received the SOS intervention. Results Thirty one practices were recruited from the UK’s largest Health Board area. At randomisation, 16 practices were allocated to the SOS intervention and 15 to UC with 4,040 patients included at baseline. Recruited practices showed few differences compared with invited, non participating practices. Practices and patients randomised to each arm of the study had similar distributions with respect to age, complications, cholesterol levels and statin prescribing. The mean age was 68 years; 53% male, 45% ischaemic aetiology. Fifty nine percent had no statin prescribed at baseline; only 51% had cholesterol controlled. Follow up included 7586 patients in 29 practices (one practice had disbanded between recruitment and randomisation and another practice dropped out). Compared with UC, the SOS intervention achieved the primary endpoint of increasing the proportion of patients prescribed Simvastatin 40mg with controlled cholesterol (SOS 44.9% vs. UC 27.9%; odds ratio 1.79 (95% CI: 1.61, 1.98), p< 0.001). Secondary endpoints were also improved in the SOS arm practices. The intervention effect was strong and consistent across most subgroups including a positive impact on patients from practices in areas of greater socioeconomic deprivation. Conclusion A pragmatic, new, complex intervention was developed, tested and shown to be effective in a cluster randomised controlled trial with good internal and external validity. If implemented on a wider scale, in practices with comparable characteristics and baseline prescribing, the SOS intervention has the potential to reduce the burden of vascular events for patients with vascular disease. This work provides a convincing evidence base for the role of pharmacists collaborating with primary care practices, to improve statin prescribing and drug based cholesterol management, for patients at highest risk of suffering vascular events

A cluster randomised controlled trial of a pharmacist-led collaborative intervention to improve statin prescribing and attainment of cholesterol targets in primary care

Background: Small trials with short term follow up suggest pharmacists’ interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.&lt;p&gt;&lt;/p&gt; Methods: We allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4–2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.&lt;p&gt;&lt;/p&gt; Findings: We randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00–1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.&lt;p&gt;&lt;/p&gt; Interpretation: Through a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population

Subsoil Acidity Determines Survival of Lucerne on a Highly Acidic Soil

Lucerne (Medicago sativa) is one of most productive perennial species in southern Australia. However, productivity is severely restricted under acid soils (Irwin et al. 2001). Fenton et al. (1996) reported that lucerne performs poorly if soil pH was below 5 and exchangeable aluminium was over 5%. It is estimated that there are 24 m ha of acidic subsoil in southern Australia (Dolling et al. 2001). A long-term liming experiment, 1992 to 2010, aimed to ameliorate subsoil acidity via a vigorous liming program (Li et al. 2001). This paper reports survival of lucerne during the 3rd cycle of the experiment from 2004 to 2009

Interventions by healthcare professionals to improve management of physical long-term conditions in adults who are homeless: a systematic review protocol

Introduction People experiencing homelessness are at increased risk of, and have poorer outcomes from, a range of physical long-term conditions (LTCs). It is increasingly recognised that interventions targeting people who are homeless should be tailored to the specific needs of this population. This systematic review aims to identify, describe and appraise trials of interventions that aim to manage physical LTCs in homeless adults and are delivered by healthcare professionals. Methods and analysis Seven electronic databases (Medline, EMBASE, Cochrane Central Register of Controlled Trials, Assia, Scopus, PsycINFO and CINAHL) will be searched from 1960 (or inception) to October 2016 and supplemented by forward citation searching, handsearching of reference lists and searching grey literature. Two reviewers will independently review titles, abstract and full-texts using DistillerSR software. Inclusion criteria include (1) homeless adults with any physical LTC, (2) interventions delivered by a healthcare professional (any professional trained to provide any form of healthcare, but excluding social workers and professionals without health-related training), (3) comparison with usual care or an alternative intervention, (4) report outcomes such as healthcare usage, physical and psychological health or well-being or cost-effectiveness, (5) randomised controlled trials, non-randomised controlled trials, controlled before-after studies. Quality will be assessed using the Cochrane EPOC Risk of Bias Tool. A meta-analysis will be performed if sufficient data are identified; however, we anticipate a narrative synthesis will be performed. Ethics and dissemination This review will synthesise existing evidence for interventions delivered by healthcare professionals to manage physical LTCs in adults who are homeless. The findings will inform the development of future interventions and research aiming to improve the management of LTCs for people experiencing homelessness. Ethical approval will not be required for this systematic review as it does not contain individual patient data. We will disseminate the results of this systematic review via conference presentations, healthcare professional networks, social media and peer-reviewed publication

A systematic review of interventions by healthcare professionals to improve management of non-communicable diseases and communicable diseases requiring long-term care in adults who are homeless

Objective: Identify, describe and appraise trials of interventions delivered by healthcare professionals to manage non-communicable diseases (NCDs) and communicable diseases that require long-term care or treatment (LT-CDs), excluding mental health and substance use disorders, in homeless adults. Design: Systematic review of randomised controlled trials (RCTs), non-RCTs and controlled before–after studies. Interventions characterised using Effective Practice and Organisation of Care (EPOC) taxonomy. Quality assessed using EPOC risk of bias criteria. Data sources: Database searches (MEDLINE, Embase, PsycINFO, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Applied Social Sciences Index and Abstracts (ASSIA) and Cochrane Central Register of Controlled Trials), hand searching reference lists, citation searches, grey literature and contact with study authors. Setting: Community. Participants: Adults (≥18 years) fulfilling European Typology of Homelessness criteria. Intervention: Delivered by healthcare professionals managing NCD and LT-CDs. Outcomes: Primary outcome: unscheduled healthcare utilisation. Secondary outcomes: mortality, biological markers of disease control, adherence to treatment, engagement in care, patient satisfaction, knowledge, self-efficacy, quality of life and cost-effectiveness. Results: 11 studies were included (8 RCTs, 2 quasi-experimental and 1 feasibility) involving 9–520 participants (67%–94% male, median age 37–49 years). Ten from USA and one from UK. Studies included various NCDs (n=3); or focused on latent tuberculosis (n=4); HIV (n=2); hepatitis C (n=1) or type 2 diabetes (n=1). All interventions were complex with multiple components. Four described theories underpinning intervention. Three assessed unscheduled healthcare utilisation: none showed consistent reduction in hospitalisation or emergency department attendance. Six assessed adherence to specific treatments, of which four showed improved adherence to latent tuberculosis therapy. Three concerned education case management, all of which improved disease-specific knowledge. No improvements in biological markers of disease (two studies) and none assessed mortality. Conclusions: Evidence for management of NCD and LT-CDs in homeless adults is sparse. Educational case-management interventions may improve knowledge and medication adherence. Large trials of theory-based interventions are needed, assessing healthcare utilisation and outcomes as well as assessment of biological outcomes and cost-effectiveness

Perspectives of people experiencing homelessness with recent non-fatal street drug overdose on the Pharmacist and Homeless Outreach Engagement and Non-medical Independent prescribing Rx (PHOENIx) intervention

IntroductionIn Scotland, a third of all deaths of people experiencing homelessness (PExH) are street-drug-related, and less than half of their multiple physical- and mental health conditions are treated. New, holistic interventions are required to address these health inequalities. PHOENIx (Pharmacist Homeless Outreach Engagement and Non-medical Independent prescribing Rx) is delivered on outreach by National Health Service (NHS) pharmacist independent prescribers in partnership with third sector homelessness charity workers. We describe participant’s perspectives of PHOENIx.MethodsThis study aims to understand experiences of the PHOENIx intervention by participants recruited into the active arm of a pilot randomised controlled trial (RCT). Semi-structured in-person interviews explored participants’ evaluation of the intervention. In this study, the four components (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalisation Process Theory (NPT) framework underpinned data collection and analyses.ResultsWe identified four themes that were interpreted within the NPT framework that describe participant evaluation of the PHOENIx intervention: differentiating the intervention from usual care (coherence), embedding connection and consistency in practice (cognitive participation), implementation of practical and emotional operational work (collective action), and lack of power and a commitment to long-term support (reflexive monitoring). Participants successfully engaged with the intervention. Facilitators for participant motivation included the relationship-based work created by the PHOENIx team. This included operational work to fulfil both the practical and emotional needs of participants. Barriers included concern regarding power imbalances within the sector, a lack of long-term support and the impact of the intervention concluding.ConclusionsFindings identify and describe participants’ evaluations of the PHOENIx intervention. NPT is a theoretical framework facilitating understanding of experiences, highlighting both facilitators and barriers to sustained engagement and investment. Our findings inform future developments regarding a subsequent definitive RCT of PHOENIx, despite challenges brought about by challenging micro and macro-economic and political landscapes

Medicines prescribing for homeless persons:analysis of prescription data from specialist homelessness general practices

Background Specialist homelessness practices remain the main primary care access point for many persons experiencing homelessness. Prescribing practices are poorly understood in this population. Objective This study aims to investigate prescribing of medicines to homeless persons who present to specialist homelessness primary care practices and compares the data with the general population. Setting Analyses of publicly available prescribing and demographics data pertaining to primary care in England. Methods Prescribing data from 15 specialist homelessness practices in England were extracted for the period 04/2019-03/2020 and compared with data from (a) general populations, (b) the most deprived populations, and (c) the least deprived populations in England. Main outcome measure Prescribing rates, measured as the number of items/1000 population in key disease areas. Results Data corresponding to 20,572 homeless persons was included. Marked disparity were observed in regards to prescribing rates of drugs for Central Nervous System disorders. For example, prescribing rates were 83-fold (mean (SD) 1296.7(1447.6) vs. 15.7(9.2) p = 0.033) items), and 12-fold (p = 0.018) higher amongst homeless populations for opioid dependence and psychosis disorders respectively compared to the general populations. Differences with populations in the least deprived populations were even higher. Prescribing medicines for other long-term conditions other than mental health and substance misuse was lower in the homeless than in the general population. Conclusions Most of the prescribing activities in the homeless population relate to mental health conditions and substance misuse. It is possible that other long-term conditions that overlap with homelessness are under-diagnosed and under-managed. Wide variations in data across practices needs investigation. Impact of findings on practice statements The majority of prescribing activities focused on homeless populations relates to mental health conditions and substance misuse. Our findings suggest potential under-diagnoses and under-treatment of other long-term health conditions such as cardiovascular and respiratory conditions in homeless populations. Improving access to prevention and treatment of wider long term health conditions that overlap with homelessness and promoting medicines optimisation and adherence to prescribed treatments are key to improving the health of homeless populations

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&mdash;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

Community pharmacy-based opiate substitution treatment and related health services: a study of 508 patients and 111 pharmacies

Background and aims&nbsp; Community pharmacies have a central role in the provision of opiate substitution therapy (OST) for drug misusers, offering accessible, additional health services within recovery-oriented systems of care. However, little is known about the patients receiving OST, availability and uptake of related services and associated pharmacy characteristics. We aimed to describe OST in terms of patients, pharmacies and services within the UK&rsquo;s largest health authority, NHS Greater Glasgow and Clyde, Scotland.&nbsp; Methods&nbsp; Patients completed semi-structured questionnaires and pharmacists provided summary statistics relating to OST provision.&nbsp; Results&nbsp; Responses from 508 patients receiving OST from 111 participating pharmacies revealed an established patient population, with 89% (449/507) aged 30years or above and 80% (387/484) attending the same pharmacy for 1year or more. Methadone was the main form of OST (96% (487/508), with 97% (491/504) receiving supervision. Within pharmacies, OST consumption was supervised in one of four main areas: consultation room, dispensing hatch, quiet/private area or over the counter. Location of supervision was considered suitably private by 96% of patients. Positive staff attitudes, privacy and the provision of additional health services were key factors influencing choice of pharmacy. Additional health services were offered to 75% of patients and included information provision (43%), signposting to other health care providers (72%) and a Scottish service offering free advice and medicines for minor ailments (74%).&nbsp; Conclusion&nbsp; Patients and pharmacists have developed working relationships, enabling access to multiple services associated with health gain and harm reduction. Further development of enhanced services in community pharmacies is merited