Aims and objectives
The aim of this project is to describe and define Emergency Department (ED) enhanced clinical pharmacy practice and to develop the methodology needed to investigate the impact of this practice on a defined patient outcome.
The objectives are to:
- Develop an instrument to collect data about the work of ECPharms (work package (WP) 1)
- Identify and recruit research participants to collect data using the data collection instrument (WP2)
- Analyse data collected to describe and define ED enhanced clinical pharmacy practice (WP2)
- Identify a patient outcome that ECPharms may impact using findings of WS2 and patient and professional focus groups (WP3)
- Develop the methodology needed to determine this impact (WP3)
- Widely disseminate findings of WP1-3 to the academic and practice communities
The programme of research will be conducted by the lead applicant at Manchester Pharmacy School, supported by co-applicants and the advisory committee outlined.
Benefits to patients/public
It is widely accepted that there are now serious problems with emergency care provision in the UK. Indeed, it is hard to remember a week where the emergency department was not the focus of significant media attention. The public are now fluent in ED terminology. They understand what the four-hour target is and the delays they may face if they want to see a healthcare professional in their local department. The potential benefits of this research for patients relate to the quality of care patients receive.
This research will encourage more hospitals to recruit an ECPharm meaning that more patients are cared for by pharmacists. If hospitals have evidence to show that they can fill staff rota gaps with ECPharms they may be more inclined to do so. Without evidence, this kind of progression will be slow or may never happen. Optimal staffing will enable EDs to offer their patients more timely care, and therefore improve quality of care. In addition to delayed medical care, more often than not ED patients do not receive any pharmaceutical care. Through encouraging more EDs to recruit pharmacists, more patients will receive pharmaceutical care.
With more pharmacists working in the ED, patients will also likely receive safer care. ED medication errors are very common due to the hectic and stressful nature of the department. In the United States, ED pharmacists (who do not work in an enhanced role) have been shown to reduce prescribing errors by up to 67%1.
Patients will be involved in this research. We will recruit those who have previously been treated in EDs to focus groups in WS 3 to learn what a patient outcome means to ED patients, and how they think pharmacists could impact patient outcomes.
Benefits to pharmacy practice
This research will explore a very new area of pharmacy practice. We will create an evidence base for ECPharms that will be used to expand and develop this novel practice. For example, it is hoped that our findings will be used to support business cases of hospitals or pharmacy departments that want to introduce this role to their ED. This work will enable more pharmacists to become enhanced practitioners. We believe that more pharmacists would like to take on an enhanced clinical role, using all their skills to manage patients independently, for professional development and increased job satisfaction.
We may find that multiple different ED pharmacist roles are actually developing simultaneously. Some of the pharmacists investigated may work in more of a traditional clinical pharmacy role, whereas others work more like a practitioner, focusing their time on managing patients in more of a medical role. We will explore the boundaries between this traditional and enhanced work, looking at how these types of work complement or are at discord with each other. Pharmacists who diagnose patients may be better placed to treat patients better, because they have a broader clinical picture.
Through development of methodology in WP 3, we will make ground-breaking progress in this field. We will determine how the impact of these pharmacists could be investigated. The methodology developed in WP 3 will be used in the future work of the lead applicant to demonstrate how pharmacists can actually affect patient outcomes. Through dissemination of these future findings, the pharmacy profession, other professionals and policy makers will be made aware of how these pharmacists impact patient care. The project proposed here will enable this future work. Dissemination of our method development will help support others who may want to research the impact of these pharmacists on patient outcomes and the wider ED. In effect, this work will hopefully stimulate further research in this field.
We will encourage greater inter-professional collaboration, enhancing the status of pharmacy practice amongst other professions. Our research will involve other healthcare professionals to learn from their experiences of working in the ED, professionals who will learn about what ED enhanced pharmacy practice is. Dissemination efforts will further support this with findings being presented to and distributed to many healthcare professional stakeholders.
This work will support the development of national educational standards for ECPharms. As we do not currently know what these pharmacists do, there is a lack of evidence to inform such standards e.g. how training could be improved. Through supporting educational standards, this work will indirectly improve the role of ECPharms through improving the education of these pharmacists.
1. Patanwala AE, Sanders AB, Thomas MC, Acquisto NM, Weant KA, Baker SN, Merritt EM, Erstad BL. A Prospective, Multicenter Study of Pharmacist Activities Resulting in Medication Error Interception in the Emergency Department. Annals of Emergency Medicine. [Internet] 2012 [cited 25 Mar 2016]; 59(5):369-373. Available from: http://www.sciencedirect.com/science/article/pii/S0196064411017987
There has recently been increased interest in pharmacists with enhanced clinical training working within the ED. Findings from Health Education England (HEE) have outlined how these pharmacists could support the ED, but nothing is known about what pharmacists already working in this role actually do in practice nor their impact on ED patient care. This research proposal consists of three work streams to investigate these unknowns.
The UK ED is central to NHS emergency care provision. Last year, over 22 million patients were cared for by EDs1. Presenting complaints range from the serious, such as injuries due to road traffic accidents, to the less serious, such as minor wounds. Over the last 10 years, demand for emergency department care has increased annually. In 2004, in response to initial increases in demand, the government introduced the ‘four-hour’ target in order to monitor the performance of departments2. Today, this target requires hospitals to see, and either discharge or admit, 95% of patients within four hours. Since 2011, hospitals have regularly missed this target, particularly over winter when departments are under most pressures. December 2014 was particularly poor with 91% of hospitals failing to meet the target3.
There are a number of reasons why hospitals miss this target, including an increased demand for services, patients using the ED inappropriately, inadequate funding and staff shortages. At the time of writing, medical staff shortages have closed Chorley Hospital ED in Lancashire. In 2013, 50% of emergency medicine training posts for doctors were unfilled4. As a result, HEE formed an ‘Emergency Medicine Taskforce’ to solve ED staffing problems. The taskforce made a number of recommendations including making the specialty more attractive to trainees and using other healthcare professionals5. This led to increased interest in emergency department pharmacy practice.
In 2014, Health Education West Midlands investigated the potential for pharmacists to manage ED patients independently, fulfilling tasks typically undertaken by doctors and nurses6, 7. They also found a potential role for pharmacists to provide ED patients with pharmaceutical care, particularly for elderly patients with more long term conditions and more medicines than other groups8. The number of older people is increasing and they are visiting EDs more often, meaning that the need for ED pharmaceutical care will only increase.
The ‘West Midlands ED Pilot’ found that pharmacists with independent prescriber and enhanced clinical skills training (ECPharms) could potentially manage up to 39.8% of ED patients. HEE replicated the pilot nationally, finding that 35.7% of patients could be managed by these pharmacists. This identified a clear potential for pharmacists to manage ED patients and support medical staff shortages. Subsequently, a number of postgraduate enhanced clinical skills courses for pharmacists were set up, many of which are taught alongside an independent prescriber qualification. One example is the Advanced Specialist Training in Emergency Medicine (ASTEM) programme at Manchester Pharmacy School with the first cohort of pharmacists completing in June 2016. The programme trains pharmacists who can take a medical history, clinically examine, diagnose and treat patients.
A small number of ECPharms already work in UK EDs and with the availability of postgraduate courses, more pharmacists will soon be working in this role. Anecdotal evidence suggests the roles of current ECPharms within the ED vary, with some using their enhanced training to manage patients completely independently and others focusing on the provision of pharmaceutical care comparable to a ward-based clinical pharmacist.
No research has yet been undertaken to comprehensively investigate the work undertaken by ECPharms, and therefore, ED enhanced clinical pharmacy practice is without description and definition.
We want to understand how these pharmacists contribute to ED patient care and the wider ED. It may be that multiple roles are developing concurrently that can support the ED in different ways e.g. a pharmacist who more closely resembles a practitioner, managing patients independently; and, a more traditional pharmacy role with responsibility for tasks such as medicines reconciliation. We will outline the professional jurisdiction of ED enhanced clinical pharmacy. This is crucial when establishing a new role because it outlines a scope of practice. This should lead to recognition of the role, and due to ongoing staff shortages, will likely support its expansion to other EDs. A professional jurisdiction will ensure that the multidisciplinary ED team know what to expect from these pharmacists and that the pharmacists know what is expected of them. Finally, understanding what these pharmacists do will be useful for providers of postgraduate courses who want to make sure that their training provides pharmacists with the skills they will need in practice, such as increasing toxicology. Therefore, the first research question is: What is the work of enhanced ED clinical pharmacists?
In addition to not knowing how ECPharms contribute to the care of ED patients, the impact on patient outcomes is unknown. Patient outcomes are “measures of the end result of what happens to patients as a consequence of their encounter(s) with the healthcare system”9. The goal of healthcare systems is to maximise positive outcomes and minimise negative outcomes9. It is important to determine the effect of these pharmacists on patient outcomes to conclude whether they make a difference to patients, in effect, how well they contribute to patient care.
Currently, given a lack of research, we do not know whether patient outcomes could be optimised through the care of an ECPharm. For example, it may be that pharmacist review of ED patient prescription charts reduces medication error, improves prescribing appropriateness, and for those subsequently admitted to hospital, reduces their length of stay. Determining the impact of a new professional role on patient outcomes is complex and requires the development of new methods. Using findings from the first research question, and additional methods described at (E), this project will identify a patient outcome suitable for measuring ECPharm impact, and develop the methodology needed to investigate that impact. The lead applicant will then go on to use this methodology in his future work. Therefore, the second research question is: What is the methodology required to determine the impact of ED enhanced clinical pharmacists on a defined patient outcome?
This study is needed now because there is a clear surge of interest in ED enhanced clinical pharmacy practice, yet only the HEE studies have been identified in literature searches of peer-reviewed journals, conference abstracts and the grey literature nationally or internationally. Whilst the HEE studies concluded what ECPharms could do, we propose to investigate what they actually do in practice and develop methods need to determine their impact on a patient outcome.
Researchers who conducted the West Midlands and national studies recently outlined their plans for further work that will identify the training needs for ECPharms (something that our work will also support) and analyse the medication history of ED patients. Both are important, but the most pertinent task now is to describe and define this novel area of practice so that pharmacy can demonstrate how, and how well, it is supporting ED patients and the wider department. Looking further afield, this work will also build on the ED pharmacy practice research of other countries, such as the United States, where pharmacists more commonly work in the ED but not in an enhanced role. This work may encourage such countries to upskill their ED pharmacists to enhanced status and consequently improve patient outcomes on a global scale.
The findings of this research will be used to create the foundations of ED enhanced clinical pharmacy practice. Further, reasons that necessitate definition and description will be resolved. For example, publication of findings will provide evidence for those who want to implement an enhanced clinical pharmacist to their hospital ED. To support this, findings will be widely disseminated using the research teams links with national ED organisations and leaders.
Plan of investigation
Three work streams are proposed. Work package one (WP1) and work package two (WP2) are two halves of a cohort study that will follow ECPharms to determine their work and answer question one. Work package three (WP3) will use the findings of WP2 and further methods described below in order to address research question two.
WP1 – development of data collection instrument
A data collection instrument will be developed for enhanced clinical pharmacists to self-report their work in the ED. This instrument will be developed using the iPad application Form2, licensed to Manchester Pharmacy School.
Part one will allow pharmacists to report patient specific work after they contribute towards the care of individual patients, for example, enhanced tasks such as ‘conducted abdominal examination’ or traditional tasks including ‘completed medicines reconciliation’. This will enable the ratio of enhanced and traditional work to be investigated. Non-identifiable patient characteristics will be captured to help describe which patients are cared for by the pharmacists. Characteristics recorded will include age, presenting complaint, triage category (e.g. red (life threatening) or blue (non-urgent)) and diagnosis.
Part two will allow pharmacists to report their contribution to the wider ED. This includes ordering stock medicines and ensuring prescription pads are out of patients’ reach. Free text comments will enable pharmacists to capture any unexpected work, given the novel nature and variation of the role.
The instrument will be iteratively developed, using repeated visits to observe ECPharms in practice, with the researcher completing prototypes as if he was the ECPharm. Any issues identified will be recorded to enable refinement. This will continue until no further problems are found and development will then progress to pilot testing. The pilot will involve two ECPharms known to the research team using the tool in practice. Their opinions of tool content, and experiences of using it, will guide final developments.
Self-reported data collection will allow for collection of large amounts of data from many pharmacists working anywhere in the UK, impossible to collect in a reasonable timeframe by observation. Self-reported data collection has been used previously to successfully investigate new professional roles1. Form2 has been chosen as it can be used to create user-responsive instruments with conditional fields, that ask only relevant questions dependent on previous answers. These pharmacists are under significant pressure as they pioneer a new role, which means that a simple and effective data collection instrument is required so not to add to this pressure. Form2 overcomes difficulties with gaining internet access in some hospitals, as data will be collected offline and then uploaded later to a secure Form2 account at the University of Manchester when an internet connection is available.
A direct observational data collection method was considered, but not pursued. Observation visits found that, with the pressures of their new role, pharmacists would be significantly distracted by continuous observation. Therefore, this method would not produce data that truly reflects the role of these pharmacists and would lead to false conclusions. Direct observation is very time consuming, requiring significant resources to collect the large amount of data self-reporting methods achieve.
WP2 – data collection and analysis
Pharmacists will be recruited by various means. Firstly, pharmacists known to the researcher will be invited to participate by e-mail. These will be graduates of the ASTEM programme and others known to be working as enhanced clinical pharmacists in the ED. Secondly, postgraduate course providers who train these pharmacists will be asked to forward a study invitation to those who are due to complete the course. Also, local and national professional networks and organisations, such as the Centre for Pharmacy Postgraduate Education, will be used to support recruitment. It is envisaged that the recruitment of eight to twelve participants will allow for sufficient data collection, however, recruitment will continue after data collection has started to maximise the amount of data collected. No sampling will be used because there are not a large number of ECPharms; the aim will instead be to recruit as many participants as possible.
The research cohort of ECPharms will be described at baseline (demographics, pharmacy experience, qualifications). Participants will then each be asked to use the data collection instrument to record their work over a two-week period, during working hours. The researcher will deliver an iPad to participants with the Form2 application pre-installed and provide training in how to use these to ensure effective and proper data collection. Data collection will occur in staggered phases, with up to four pharmacists collecting data at any one time using iPads, and will continue until all pharmacists have contributed. Three months have been allowed for data collection to enable many flexible data collection phases. When a pharmacist has finished collecting data, this will be exported to SPSS to enable analysis.
Data collected by each pharmacist will be analysed individually to understand their tasks to support patients and the frequency distribution of these. We will also be able to understand whether pharmacists conduct more enhanced or traditional work, and the relationship between these. The work of these pharmacists will then be compared using a graphical heat map method of analysis. This method will allow three variables (the pharmacists, tasks undertaken and task frequency) to be visualised simultaneously and will support description of how the roles of these pharmacists compare. At this point it will be possible to define the jurisdiction of enhanced ED clinical pharmacy practice.
Further analysis will be more patient focused. It will determine how patients are cared for, such as the number of pharmaceutical care interventions individual patients receive. We will investigate the types of patient pharmacist’s care for, including their patient’s age, presenting complaint, triage category and diagnosis. Given the variety of presenting complaints, it may be that ECPharms only support patients with certain complaints or they may support some patients differently. For example, for patients who are managed in ‘Resus’ (an area with resuscitation facilities for the very sick), pharmacists may predominantly offer pharmaceutical care, whereas for those managed in Majors (such as sepsis patients) pharmacists may provide more enhanced care.
WP3 – identification and definition of a patient outcome and methodological development
Before methodology to determine the impact of ECPharms is developed, a patient outcome suitable for impact investigation will be identified and defined. This will involve a combination of two approaches.
First, the findings of WP2 will be used to identify what patient outcomes ECPharms may directly or indirectly impact upon. For example, if WP2 concludes that pharmacists intervene in the care of patients where a medication side effect was responsible for admission to hospital, a relevant patient outcome worthy of method development would be hospital re-admission rate, with the hypothesis that these pharmacists would reduce hospital re-admissions.
Second, the views of past ED patients and those who work in the ED will be considered. Between 4 and 8 participants will be recruited for each of four focus groups, using poster and e-mail advertisements. Two focus groups for patients and two for professionals (each including doctors, nurses and pharmacists) will be arranged to gain insight as to what ED patient outcomes these groups feel are important and require investigation. Participants’ thoughts about the potential impact pharmacists may have on these outcomes will be sought. Focus groups will take place at Manchester Pharmacy School and be recorded. Participants will be given a shopping voucher to thank them for their time. Qualitative data collected will be transcribed and then analysed using the data management software NVivo.
The lead applicant and co-applicants will then use the findings of both of these approaches to identify and define a patient outcome for which impact methodology will be developed.
The quantitative methodology developed will consider structure and process constructs to ensure rigorous outcome measurement. Structural constructs focus on characteristics of the ED, such as staff and facilities, whilst process constructs look at what is actually done to patients. Method development will first require a comprehensive review of literature about investigating patient outcomes in the ED in order to learn of methods previously developed. Literature searches to date have only found studies that focus on the impact of nursing and medical professionals on ED patient outcomes, and some studies from other countries that address the impact of ED clinical pharmacists working in a traditional rather than enhanced role.
Next, the steps crucial to the development of methodology to assess patient outcome impact will be undertaken. This will firstly involve identifying the data necessary and accessible to address the impact of ECPharms on the chosen outcome. The data required will depend significantly on the outcome being investigated. Examples of data sources that could be used include patient medical records, patient surveys or ED administrative data. The lead applicants’ network of ED staff will be used to look into data accessibility. Following these steps, an appropriate data collection instrument will be developed to capture the required data. The instrument will be validated through pilot study to ensure that it will reliably collect the data needed. Finally, data analysis methods that conclude the impact of these pharmacists on the chosen outcome will be identified or developed. In order to support this final stage, the lead applicant will attend data analysis courses, such as statistics courses, at the University of Manchester. An appropriate study design (e.g. randomised controlled study or cohort study) will be identified, for future investigations as to the impact of ECPharms on the defined outcome. Such investigations will be the subject of future grant applications.
In summary, similarly to the introduction of enhanced practice, this proposal is bold and crucial. WP1-3 will enable the proposed research questions to be answered. A clear gap in current understanding will be addressed and therefore enable ED enhanced clinical pharmacy practice to establish, develop and expand to other EDs across the UK. A lack of research currently hinders progress because no one truly knows what ECPharms do in practice and how patients may benefit. Investigating the work of these pharmacists will allow their practice to be outlined, and more importantly their impact on patient outcomes to be investigated. This research will help pharmacy to better help the ED – a department in difficulty.
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