Advanced Clinical Practitioners in the ED

Healthy Volunteers Clinical Trial

Official title: Advanced Clinical Practitioners in the Emergency Department: A Mixed-method Study of Practice Using Resilient Health Care Principles

Status Not yet recruiting

Clinical Trial Summary

No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is:

1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?

With secondary aims :

1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?

2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?

Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data:

1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED.

2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles.

Background

In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master's degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.

These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills.

Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care.

Clinical Trial Description

Over the last decade, increasing demands have been placed upon emergency departments in the UK and globally. 'Overcrowding' in ED occurs when the number of patients waiting to be seen, treated or transferred to inpatient beds exceeds staffing and physical resources. The worsening mismatch between demand and capacity results in 'boarding' (where patients are held on corridors awaiting an inpatient bed), the incidence of which has increased over the last decade. A prolonged length of stay in ED creates delays in treatment for patients and has been shown by multiple studies to cause harm. Despite crowding being a global problem, there remains a lack of evidence regarding interventions that reduce patient demand, increase throughput and expedite the output of emergency departments.

Creating flow is multifactorial but does require emergency departments to have the right skill mix of clinicians to see patients in a timely fashion. In 2006, Trusts developed the Emergency Care Advanced Clinical Practitioner (EC-ACP) role. EC-ACPs are predominantly nurses or paramedics but can be from any allied health profession; they undertake masters-level courses and supervision in practice to enable them to see the complete spectrum of presenting complaints in ED. The EC-ACP role was created to meet higher service demands caused by reduced junior doctors' working hours, medical training changes, increased patient complexity, and higher hospital attendance.

There has been extensive support for advanced practice roles within health policy. However, policies focus on the need for a broader workforce performing extended roles but fail to fully address the many systems impacts of advanced practice, including but not limited to changing the dynamics of interprofessional collaboration. Advanced roles have frequently caused concern to doctors as they feel that their professional territory is infringed. The nursing profession has also criticised advanced practice roles because senior staff, such as those in the nurse-in-charge role, occasionally move from their current positions into clinician roles. This creates broader professional concern that skilled and experienced nurses leave traditional nursing roles to address medical staffing deficits.

Most research on advanced roles in ED has adopted reductionist approaches, comparing nurse practitioners and doctors on individual tasks. For example, researchers have sought to determine if patients are satisfied with non-medical clinicians by investigating if they are as quick, cost-effective and accurate on a given task (like identifying broken bones on X-rays) as their medical equivalent. The problem with these methods is that they perpetuate misunderstandings between professional groups as differently trained staff are compared on a task-only basis. Therefore, studies directly comparing EC-ACPs and doctors may negatively impact interprofessional relationships. It is essential to understand these tensions between staff groups as care is delivered to patients by multi-professional teams. If the EC-ACP introduction causes conflict within teams, this may harm patients. The research team also asserts that previous research focusing only on productivity and tasks has failed to address the complexity of EC-ACP introduction to the emergency care system. As the number of EC-ACPs continues to increase, research must be conducted to review the impact of EC-ACPs from a systems perspective. Only by adopting new approaches to research will the emergency care community understand the challenges of integration and contribution from EC-ACPs in the workforce.

Internationally, there is growing interest in using a new approach called Resilient Healthcare (RHC) to research how staff in complex systems complete clinical work every day. RHC is a coherent theoretical model; evidence for using the theory is mounting, but empirical work in practice remains limited. RHC suggests that healthcare work is not simple; it is complex, adaptive, variable, and unpredictable. Interplays between departmental demands and capacity result in dynamic decisions being made by staff, changing how they work to maintain service. RHC acknowledges that there will always be variability in how staff complete their work. How everyday clinical work is completed is termed 'work-as-done' (WAD) and often compared to 'work-as-imagined' (WAI), predefined working methods determined by managers or leaders. The difference between WAD and WAI represents a safety concern as if real-life working processes are not fully understood. We do not know how EC-ACPs work in emergency care teams as there is insufficient empirical evidence.

Using a systems-based approach, the next step for expanding the evidence base for EC-ACPs is to increase our understanding of their contributions to emergency care and the key challenges they face in their work. The investigators aim to complete ethnographic observations and semi-structured interviews in two emergency departments to enable a comparative case study research design.

Study Design:

Phase one consists of ethnographic observations at two clinical sites at different time points of integrating EC-ACPs to observe WAD by ACPs. Comparing the two sites will identify differences in ACPs implementation, staff experiences, and work processes. This may enable theoretical generalisability by comparing and contrasting WAD by EC-ACPs at two sites. Researching new and mature EC-ACP systems may identify shared factors that facilitate or hinder integration. Understanding how developed systems address barriers to EC-ACP practice will be beneficial.

Phase two will be semi-structured interviews to explore themes relating to WAD and RHC based on the observations of ACPs in phase two. During phase two, the investigators will also aim to speak to staff on a micro-level (consultants, senior nurses) and a meso-level (general managers, clinical directors, matrons) to understand their perceptions of WAI vs WAD, teamwork, and role implementation.

Observations:

The investigators will aim to shadow x5 EC-ACPs from each site (n=10) for at least five hours, up to a maximum of ten hours each, totalling at least 50hrs of observation in clinical practice. The investigators found it challenging to determine the exact number of hours that are required in the field. Earlier RHC studies conducted in ED at single sites that used direct observations have undertaken a variety of hours in the field ranging from 45hrs (Wachs, et al., 2016) to 104hrs (Anderson, et al., 2020). The investigators plan to have repeated discussions with the supervisory team to determine when enough data has been collated. Recruitment can continue if new informants contribute new information or discontinued if no new themes are identified. It is most likely that the EC-ACPs participating will be from nursing or paramedical backgrounds; however, any qualified EC-ACP will be welcome to contribute to both aspects of the study: observations and interviews.

Non-participant observations will be undertaken in the Emergency Department. EC-ACPs will be observed as they conduct their normal daily activities within the complex sociotechnical system. The investigators will observe EC-ACP interactions with other staff, cross-boundary discussions, and using technology. The investigators will not observe the EC-ACPs undertaking clinical examinations of patients because the focus of this study is not direct clinical care. Junior clinicians may approach senior EC-ACPs for advice regarding the clinical care of their patients, the discussions about patient medical plans will not be recorded or processed. The investigator's experience suggests that these initial clinical discussions, subsequent feedback, and onward plans usually occur in an area away from the patient's bedside. It should, therefore, be possible to understand the interactions by observing these discussions without being by the bedside.

Activity and staffing in emergency departments vary depending on the time of day, meaning that patients wait longer to be seen at night, resulting in more patients being admitted or leaving without being seen (Simpson, et al., 2018). There are fewer senior doctors overnight, with fewer registrars and often no consultants present in the ED after 2 am. This means that the ED is staffed with predominantly junior clinicians overnight. As the experience levels in the team alter overnight, EC-ACPs may be required to change how they work to meet demands out of hours. To observe for variance in EC-ACP practice out of hours, the researcher will perform observations of participants in five-hour blocks throughout the twenty-four-hour period.

Observation periods will be up to a maximum of five hours per 24-hour period to not overly burden the participant and ensure a high quality of data collection. Data collection will aim to capture the variation in work-as-done by observing ACPs Monday-Sunday between the following hours (08:00-13:00, 13:00-18:00, 18:00-01:00, 01:00-06:00). After a day of observing participants the day after will be used to write up observational data in greater detail. Data will be captured in contemporaneous field notes. Broad and descriptive annotations and observations will be made about the work activities of ACPs using data collection tools informed by the scoping review.

EC-ACPs will be observed in the ED 'Board-Rounds'; these are two to three hourly gatherings of staff to discuss the current challenges and demands in the department. Discussions regarding patients' medical care may be overheard, but no data will be recorded or processed on patients. Observing board rounds is necessary as it may enable the investigators to view how EC-ACPs interact in the multi-disciplinary team and how consultants or senior nurses coordinate resources, including if EC-ACPs are moved around the department to meet demands. The board rounds are also an opportunity to anticipate future demands, respond and potentially monitor the effectiveness of earlier interventions (Back, et al., 2017).

Anderson & Ross's (2020) observation of the Work-As-Done guide will provide some initial guidance for data analysis (Anderson & Ross, 2020). A deductive-inductive approach will be used to analyse data. Deductive themes based on the RHC activities of anticipation, response, monitoring, coordinating and learning will be used to organise data. Deductive data will be supported by an inductive process, with additional codes developed from the data as the study progresses. At the end of the observational period, all items on the mobile device from the study will be transferred to the researchers' computer at KCL and then deleted from the mobile device. The observation period is expected to last for six months.

Interviews:

Semi-structured interviews will be undertaken with a range of professional stakeholders (n=20), with ten from each Trust. Interviews will be conducted using a topic guide in an open-ended fashion, facilitating exploration of the questions with the participant (Pope & Mays, 2006; Green & Thorogood, 2018). The topic guide will include questions regarding the history of EC-ACP integration into the emergency care team, what specific challenges were encountered, how these were overcome, and what contribution the role has made to the emergency care system from various professional perspectives. The investigators will remain flexible in exploring concepts of interest and any remaining questions or themes from the early analysis of observations. If the interview participant was involved in the observation stage of data collection, some questions to clarify observations deriving more significant insights from the data (Pope & Mays, 2006). Interviews will accommodate the times and dates most suitable for participants. It is envisaged that the 'gatekeepers' at both workplaces will suggest safe and appropriate locations on the two sites for conducting the interviews (Green & Thorogood, 2018).

Study Setting: Two type one Emergency Departments in the UK, one with greater and one with lesser experience of implementing the role of EC-ACP.

Participant selection:

To examine the experiences of EC-ACPs of introduction, interprofessional teamwork, communication, challenges and contributions to organisational resilience in ED, the investigators will also conduct semi-structured one-to-one interviews. The semi-structured interviews will be conducted with several stakeholders from the multidisciplinary team. This is to improve the investigators' understanding of challenges to integration and contributions from EC-ACPs on multiple system levels. The staff that will be approached for interviews will include:

• Clinical Directors

• Matron/head of nursing for ED

• Lead ACP ED

• Consultants

• Registrars

• Senior sisters in ED

• Staff Nurses

• Qualified ACPs The interviews will contextualise previous observations and provide a deeper understanding of how EC-ACPs conduct everyday work and the barriers and facilitators to their integration.

Recruitment:

An introductory letter to ED gatekeepers will describe the study's aims and explain how understanding how EC-ACPs work and their introduction to the ED may benefit emergency care. This will increase their understanding of RHC and help justify why the approach is being used to review EC-ACP practice. If the gatekeepers permit access to the site, the next step will be to contact the research and development teams at each site. Upon request, a complete research protocol will be shared with the relevant research leads.

The investigators will then request that the gatekeeper/clinical leads introduce the ED team. An email invitation will be extended to ED staff to a meeting and information-sharing event. Information sessions will be provided for staff working in the ED, and materials describing the study will be circulated to staff. The investigators conducting data collection will introduce themselves several weeks before the start of the research.

Personal information, such as the names of staff and email addresses, will be collected during information sharing. At the point of data collection, all participants will be given pseudonyms. The break sheet for the pseudonyms will be held with the Academic supervisors at KCL, away from any research data. It will not be held in an Excel format but in a password-protected Word document and stored in a GDPR KCL-approved cloud-based storage facility. The break-sheet will be accessible only to the KCL supervisor and student researcher.

Observations The research aims to observe how EC-ACPs work and their interactions with other staff members. Potential risks and benefits of taking part will be discussed with participants. All staff will be reassured that there will be no direct observations of direct patient encounters. Whilst observing interactions between staff in the clinical areas, no personal information will be collected or details about other staff members, patients or visitors during the study. The investigators will remain cognisant of the patient's and visitors' privacy and dignity, leaving an area once clinical examination begins. The wider ED team will be made aware that if they do not want to be observed, they can refuse to participate or withdraw from the study at any time.

Interviews At the information sessions and during ethnography, participants will be invited to ask if they wish to participate in one-to-one interviews. Staff interested in the interview stage will receive an information sheet on the process. The investigators will explain that interviews are used to explore their experiences, beliefs, and attitudes and contextualise the observational data to provide deeper insights into perceptions of how EC-ACPs work. All interview participants will be asked to sign the consent form. The interviews will provide further perspectives from staff at different organisational levels, such as managers and directors.

Participants will be informed that interviews will take no more than 45 minutes and will be conducted at an agreeable time. Interview data will be sent via secure encrypted email to a KCL-approved transcription service. The investigator will personally transcribe 10% of the data. All data will be anonymised.

Ethical Considerations:

The investigators have undertaken the Health Research Authority online evaluation of this research, which suggests that NHS REC is not required. However, it was determined by the RGO at KCL that this study would require a Confidentiality Advisory Group review because whilst investigators are not collecting or processing any identifiable data on patients, they may overhear some confidential information about patients during the course of the study. The investigators have, therefore, expanded the IRAS application to apply for CAG simultaneously. It appears likely that this study will fall under category ten of the precedent-set criteria:

Observation of a multi-disciplinary team meeting where health professionals discuss the care of patients and where the patients have not given prior consent. Although the access to confidential patient information is incidental, it still involves a breach of confidentiality in cases where that observer would not usually have access to that confidential patient information because they are not in the multi-disciplinary team meeting as part of the direct care team but instead to observe for other purposes. (https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/cag-p recedent-set-review-pathway/precedent-set-criteria/#precedent) Due to the nature of the setting, patients will be present during some observations. However, the investigators will not collect or process any patient data, as the area of inquiry relates to EC-ACPs, healthcare providers, and how they interact. Participating EDs will have posters informing patients that the study is taking place and informing them of the purpose of observations. The investigator will move away from areas where patients are receiving direct care.

This project is designed to review ACPs working within healthcare teams. the investigators accessed two forms of PPI. The PIS and information related to the study was sent to 25 ACPs who will not participate. The investigators received feedback that the forms were precise, but the test group felt that more information on what the investigators would look for during observation would be helpful. The public was involved in the design of this research, as the Chief Investigator presented the research plans at a PPI group. The group felt that whilst they had a minor concern about details of patients being overheard without consent, provided that explicit assurances were given that data were not being collated, they were satisfied the project should continue. All participants identified the need to know more about new roles in EDs. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT06355648
• Study type: Observational
• Source: King's College London
• Contact: Peter Chessum, MSc
• Phone: +44 7595931659
• Email: Peter.chessum@kcl.ac.uk
• Status: Not yet recruiting
• Start date: May 3, 2024
• Completion date: March 1, 2025