PROTOCOL
A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service Natasha Jennings*, Glenn Gardner & Gerard O’Reilly Accepted for publication 15 February 2014
Correspondence to N. Jennings: e-mail: [email protected] Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN 12613000933752. Natasha Jennings MN CCC (Emerg) RN PhD Candidate, Queensland University of Technology, Institute for Health & Biomedical Innovation, Emergency Nurse Practitioner The Alfred Emergency and Trauma Centre, Prahran, Victoria, Australia Glenn Gardner PhD RN FRCNA Professor, Director of the Centre of Clinical Nursing Queensland University of Technology and the Royal Brisbane and Women’s Hospital, Kelvin Grove, Queensland, Australia Gerard O’Reilly MBBS FACEM MPH Emergency Physician The Alfred Emergency and Trauma Centre, Prahran, Victoria, Australia
*[Correction added on 01 September 2014, after first online publication: The University was previously omitted and has now been added.]
2140
J E N N I N G S N . , G A R D N E R G . & O ’ R E I L L Y G . ( 2 0 1 4 ) A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service. Journal of Advanced Nursing 70(9), 2140–2148. doi: 10.1111/ jan.12386
Abstract Aim. To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Background. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Design. Pragmatic randomized controlled trial at one site with 260 participants. Methods. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Discussion. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Keywords: clinical trial, emergency, nurse practitioner, outcomes, protocol
© 2014 John Wiley & Sons Ltd
JAN: PROTOCOL
Why is this research or review needed? • There have been limited rigorous prospective approaches to evaluate effectiveness of nurse practitioner services in the clinical environment.
Emergency nurse practitioner
studies that support the effectiveness of nurse practitioner service in terms of the key deliverables of improved patient access, efficiency and quality of patient care to achieve healthcare reform (Wilson et al. 2008, Rother & LavizzoMourey 2009).
• A hybrid research design approach, by combining traditional randomized controlled trial elements with pragmatic features of everyday applicability will provide a balance of methodologies to undertake this health services research. This pragmatic design will measure a broad spectrum of patient outcomes to compare effectiveness of interventions in everyday practice.
Introduction Health services research is fundamental to developing knowledge and evidence that can be translated into improvements in access and delivery of health care for all patients. Health services research is both multidimensional and multidisciplinary and complements the myriad of settings in our healthcare landscape. This research paradigm is particularly important when it comes to measuring innovations in service delivery, where innovation is often defined as the introduction of a new model of care, service method or concept, aimed at improving quality of care of patients (Omachonu 2010). Delivering health care to meet population needs and increasing demands requires service leaders, policy makers and clinicians to demonstrate leadership to reform existing health services (Council of Australian Governments 2011). The nursing workforce has responded to these reform imperatives and developed and implemented a range of innovative models of care that promote the concept of healthcare reform. One model of care offering flexibility and adaptation to the changing needs of the consumer population is the nurse practitioner (NP) role. Nurse practitioners were introduced to North America in the 1960s and then further developed in the UK in the 1980s. Australian NPs were authorized in 2000 as a new model of care for healthcare delivery (Australian College of Nurse Practitioners 2010). The nature of NP work involves a hybrid model of care, which includes a combination of nursing care, diagnostic activities, intervention-based treatments and the use of medicines; some of these activities have traditionally been limited to the scope of medical practice (Gardner et al. 2010). These innovations to the traditional nursing role have led to recurrent confusion over the role, responsibility, accountability, scope of clinical practice, professional boundaries and effectiveness (Department of Health Queensland 2012). Furthermore, there is scant evidence from well-controlled © 2014 John Wiley & Sons Ltd
Background One health service area currently under pressure for reform in Australia and internationally are hospital emergency departments (EDs). In Australia, EDs have seen more than 7% growth in patient presentations over the last 5 years and this has contributed to an ever-growing burden on the delivery of quality patient care (Lowthian & Cameron 2012). The capacity of EDs to consistently deliver timely, high-quality patient care is impacted by the increase in the number and complexity of presentations. Emergency department overcrowding, access block, the growing burden of chronic diseases in the community, reduced access to primary health care have all contributed to increased demand in ED services (Sprivulis et al. 2006, Lowthian et al. 2011, Australian Health Workforce Association 2012). Emergency Department overcrowding is seen as the greatest single impediment to safe and efficient ED services in Australia and New Zealand (Cameron et al. 2009) significantly resulting in increasing waiting times, adverse events, mortality and hospital length of stay (Forero et al. 2010). National clinical indicators for ED service delivery are now government-mandated in several countries and designed to transparently monitor, analyse and evaluate a health service’s performance (Department of Health United Kingdom 2011, Department of Health Victoria 2012). There are a total of 8 defined clinical indicators compiled by the Australian Council of Healthcare Standards (ACHS) annually to provide clinical perspectives of trends in service and how to improve quality and safety of care for these patients. Emergency department overcrowding has resulted in the clinical quality indicators of time to analgesia, waiting times, length of stay and mortality becoming adversely affected and having an impact on effectiveness of patient care (Lowthian & Cameron 2012). The quality of patient care in the ED requires continuous monitoring and evaluation, particularly in the context of high demands for ED services, overcrowding and changing national time performance targets. A notable clinical indicator in the ED setting commensurate with quality outcomes is time to analgesia and pain score documentation. Acute pain is the most common precursor for patients presenting to Australian EDs (Kelly & Gunn 2008). A service issue facing the ED today is the abil2141
N. Jennings et al.
ity to deliver timely and effective pain relief. Evaluating the effectiveness of the E-NP service on time to analgesia and pain scores has great implications to provide evidence of quality of patient care. In a joint position statement released by the Australasian College for Emergency Medicine and the College of Emergency Nursing Australasia, pain management is identified as a fundamental component of quality care for ED patients (Australian College of Emergency Medicine 2012). Early and effective pain management in the ED setting may also play a pivotal role in reducing the likelihood of chronic pain syndromes and pain-related anxiety and distress following the acute pain encounter (Weisman et al. 1998, Turturro 2002, Thomas & Shewakramani 2008). Pain persisting for more than 3 months (known as persistent pain) can be debilitating and costly to healthcare services (Williamson et al. 2009). Persistent pain has a significant impact on patients’ physical and mental health and can delay functional recovery following traumatic injury (Mkandawire et al. 2002, Castillo et al. 2006). The development of interventions for the prevention of persistent pain correlates with earlier and more effective treatment of acute pain to reduce or even terminate the progression from acute to persistent pain and improve patient quality of care (Mkandawire et al. 2002, Castillo et al. 2006). Differences in pain scores and treatment effectiveness will be evaluated throughout the study. In 2007, the Australian National Institute of Clinical studies (NICS) sanctioned ‘The NICS National Emergency Care Pain Management Institute’ for the implementation of best practice in relation to ED pain management. As a result, a national audit of 36 hospitals throughout Australia (n = 1996) was conducted and results showed that a median time to analgesia in the ED was 61 minutes, where 30 minutes was considered the national standard by ED care experts (Herd et al. 2009). The study also discovered that less than 40% of patients sampled had a pain score documented at triage. The clinical indicators recommended from the report were a target of 80% of patients presenting to the ED have a documented pain score within 30 minutes, a median time to analgesia of 30 minutes from triage and their Visual Numeric Pain Score (VNPS) reduced by a score of 3 points within 60 minutes of arrival to ED. The major recommendation from the Australian Health Workforce Advisory Committee’s evaluation of ED models of care was the need to address service issues in the ED with innovative models and workforce reform. The developments of innovative models of care have been strategies to address some of these issues. The E-NP role is part of a reformative model of health service that has the potential to have a direct impact on service outcomes and quality of patient care. 2142
The study Aims The aims of this research are to compare the effectiveness of E-NP on service and quality of patient care outcomes, with that of standard care in the ED. Hence, the following null hypotheses will be tested: For patients presenting to the ED with pain, allocated to the fast track zone and who receive care from either an E-NP or standard care, there will be no difference in:
Primary outcomes 1 Pain score reduction and time to analgesia Secondary outcomes 2 Service indicators of • Waiting time • Number of patients who did-not-wait • Length of stay in emergency department • Representations with 48 hours
In addition, a comparative evaluation of clinicians’ use of evidence-based guidelines for management of: (i) knee injury; (ii) ankle injury; and (iii) burns injury will be conducted to further test the integrity of the intervention.
Methodology The nurse practitioner model is distinctive in health service delivery as an innovation that operates from within a nursing paradigm augmented by medical and other health professionals’ skills. The methodological complexities of evaluating NP service relate to the nature of NP service as an intervention that is inherently multidimensional with several interacting elements. Examining this service as a complex intervention will focus the research on patient and service effectiveness and provide an appropriate framework to guide this study. A pragmatic RCT design differs from a traditional RCT in regard to the setting, sample, interventions and the nature and level of research validity. Pragmatic designs are often characterized as having less control over variables, which come at a cost of their internal validity. The design is often reported to have low internal validity due to the limited control in the environment, flexible interventions and the heterogeneous nature of the study sample. Creating a hybrid research design by combining traditional RCT elements (high internal validity) with pragmatic features of © 2014 John Wiley & Sons Ltd
JAN: PROTOCOL
everyday applicability (external validity) produces a balance of methodologies to maximize validity of the research. This is a major strength of this design and is relevant to testing health services innovations, such as E-NP service. The methodological complexities of E-NP service relate to the number of interacting elements in E-NP service as an intervention (Craig et al. 2013). For example, E-NP nursing service is multidimensional incorporating clinical, communication and patient teaching skills in a hybrid nursing/medical service model. The connection between this service intervention and the measurable outcomes is often indirect and difficult to evaluate. This pragmatic design will measure a broad spectrum of patient-centred outcomes to compare effectiveness of interventions in everyday practice of the most common outcomes in the ED setting (Hotopf 2002). Research Ethics Committee approval was gained in December 2013 for commencement scheduled for February 2014.
Study site This is an Australian study that will be conducted in an urban, Emergency and Trauma Centre (hereafter referred to as the ED), in Melbourne, Victoria. The ED is a tertiary public hospital affiliated with several Universities. The hospital has provided emergency services since opening in 1871 and a statewide trauma service since 1989. The current integrated ED facility was commissioned in 1999. In addition to providing emergency services to the local community, the ED also provides Victorian statewide services for: Trauma (adult) and Burns (adult), Hyperbaric Medicine, HIV Medicine, Cystic Fibrosis (adult) and Haemophilia (adult), Heart & Lung Transplant, Critical Neurosurgery. The ED is a purpose-built modern facility consisting of eight Resuscitation and Trauma Bays, nineteen fully monitored general cubicles (including six rapid assessment cubicles) along with six Fast track zone cubicles. In addition, there is also a co-located eighteen-bed Short Stay Unit. The Trauma service treats more than 1200 major traumas annually, which represents greater than half of all major traumas in the state of Victoria, with an estimated annual ED attendance of 65,000 in the year 2012 (Department of Health Victoria 2012). Approximately 30% of these patients are managed in the Fast track zone. The Fast track zone in the ED is a geographical area adjacent to the main ED connected by a corridor. This area is an adjunct to processes in a treatment pathway designated for the timely assessment, treatment and discharge of people seeking primary care for less serious illnesses and © 2014 John Wiley & Sons Ltd
Emergency nurse practitioner
injuries. The six individual cubicles are centred around a staff base station and operate on a 24-hour basis. A multidisciplinary team that may include Registered Nurses, medical officers, registrars, ED consultants, musculoskeletal physiotherapists and E-NPs provides the services in Fast track. Emergency nurse practitioners work in the Fast track zone from 07:00 hours to 23:30 hours on a combination of 8- and 10-hour shifts. All patients presenting to the ED are triaged on arrival and an Australasian Triage Scale (ATS) category allocated (Australian College of Emergency Medicine 2012). The ATS is designed for use in hospital-based emergency services throughout Australia and New Zealand. The ATS is a scale for rating clinical urgency and used to ensure that patients are seen in a time frame that is commensurate with the clinical urgency of their presenting symptoms.
Inclusion/exclusion criteria The study population is all patients presenting to the ED during the sampling time frame and allocated for their episode of care to the Fast Track zone. All eligible patients will be approached by the clinical research assistants using a standardized recruitment script. The eligibility criteria for enrolment in this research are included (Table 1).
Randomization Following collection of baseline data and confirmation of patient eligibility, consenting patients in series will be randomly assigned to either the intervention or the control group by a computer-generated process. The Clinical Research Assistants (CRA) will telephone the offsite randomization service that will allocate study participants using block randomization. Randomization gives each patient a chance of being assigned to either the intervention or control groups. Successful randomization practices require that group assignment cannot be predicted in advance. Block randomization is used to ensure appropriate distribution across the two treatment arms and help reduce bias and confounding, especially when the sample size is small (Efird 2011). Allocation will adhere strictly to the generated sequence with block sizes of four. For every block of four patients, for example, two would be allocated to each arm of the trial (A = intervention and B = control), with block configurations randomly assigned. To strengthen methodological rigour, CRAs and the randomization process will all be independent of other components of the study design. A flow diagram outlining the trial design is shown in Figure 1. 2143
N. Jennings et al.
Table 1 Emergency nurse practitioner (E-NP) trial eligibility criteria. E-NP study Inclusion Criteria Age >16 years Patient presentations ATS 2-5 Pain identified in triage description Exclusion Criteria Non-English-speaking Neurovascular compromise Multiple injuries Altered conscious state including effects of drugs/Ethanol Glasgow Coma Scale
A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service Natasha Jennings*, Glenn Gardner & Gerard O’Reilly Accepted for publication 15 February 2014
Correspondence to N. Jennings: e-mail: [email protected] Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN 12613000933752. Natasha Jennings MN CCC (Emerg) RN PhD Candidate, Queensland University of Technology, Institute for Health & Biomedical Innovation, Emergency Nurse Practitioner The Alfred Emergency and Trauma Centre, Prahran, Victoria, Australia Glenn Gardner PhD RN FRCNA Professor, Director of the Centre of Clinical Nursing Queensland University of Technology and the Royal Brisbane and Women’s Hospital, Kelvin Grove, Queensland, Australia Gerard O’Reilly MBBS FACEM MPH Emergency Physician The Alfred Emergency and Trauma Centre, Prahran, Victoria, Australia
*[Correction added on 01 September 2014, after first online publication: The University was previously omitted and has now been added.]
2140
J E N N I N G S N . , G A R D N E R G . & O ’ R E I L L Y G . ( 2 0 1 4 ) A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service. Journal of Advanced Nursing 70(9), 2140–2148. doi: 10.1111/ jan.12386
Abstract Aim. To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Background. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Design. Pragmatic randomized controlled trial at one site with 260 participants. Methods. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Discussion. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Keywords: clinical trial, emergency, nurse practitioner, outcomes, protocol
© 2014 John Wiley & Sons Ltd
JAN: PROTOCOL
Why is this research or review needed? • There have been limited rigorous prospective approaches to evaluate effectiveness of nurse practitioner services in the clinical environment.
Emergency nurse practitioner
studies that support the effectiveness of nurse practitioner service in terms of the key deliverables of improved patient access, efficiency and quality of patient care to achieve healthcare reform (Wilson et al. 2008, Rother & LavizzoMourey 2009).
• A hybrid research design approach, by combining traditional randomized controlled trial elements with pragmatic features of everyday applicability will provide a balance of methodologies to undertake this health services research. This pragmatic design will measure a broad spectrum of patient outcomes to compare effectiveness of interventions in everyday practice.
Introduction Health services research is fundamental to developing knowledge and evidence that can be translated into improvements in access and delivery of health care for all patients. Health services research is both multidimensional and multidisciplinary and complements the myriad of settings in our healthcare landscape. This research paradigm is particularly important when it comes to measuring innovations in service delivery, where innovation is often defined as the introduction of a new model of care, service method or concept, aimed at improving quality of care of patients (Omachonu 2010). Delivering health care to meet population needs and increasing demands requires service leaders, policy makers and clinicians to demonstrate leadership to reform existing health services (Council of Australian Governments 2011). The nursing workforce has responded to these reform imperatives and developed and implemented a range of innovative models of care that promote the concept of healthcare reform. One model of care offering flexibility and adaptation to the changing needs of the consumer population is the nurse practitioner (NP) role. Nurse practitioners were introduced to North America in the 1960s and then further developed in the UK in the 1980s. Australian NPs were authorized in 2000 as a new model of care for healthcare delivery (Australian College of Nurse Practitioners 2010). The nature of NP work involves a hybrid model of care, which includes a combination of nursing care, diagnostic activities, intervention-based treatments and the use of medicines; some of these activities have traditionally been limited to the scope of medical practice (Gardner et al. 2010). These innovations to the traditional nursing role have led to recurrent confusion over the role, responsibility, accountability, scope of clinical practice, professional boundaries and effectiveness (Department of Health Queensland 2012). Furthermore, there is scant evidence from well-controlled © 2014 John Wiley & Sons Ltd
Background One health service area currently under pressure for reform in Australia and internationally are hospital emergency departments (EDs). In Australia, EDs have seen more than 7% growth in patient presentations over the last 5 years and this has contributed to an ever-growing burden on the delivery of quality patient care (Lowthian & Cameron 2012). The capacity of EDs to consistently deliver timely, high-quality patient care is impacted by the increase in the number and complexity of presentations. Emergency department overcrowding, access block, the growing burden of chronic diseases in the community, reduced access to primary health care have all contributed to increased demand in ED services (Sprivulis et al. 2006, Lowthian et al. 2011, Australian Health Workforce Association 2012). Emergency Department overcrowding is seen as the greatest single impediment to safe and efficient ED services in Australia and New Zealand (Cameron et al. 2009) significantly resulting in increasing waiting times, adverse events, mortality and hospital length of stay (Forero et al. 2010). National clinical indicators for ED service delivery are now government-mandated in several countries and designed to transparently monitor, analyse and evaluate a health service’s performance (Department of Health United Kingdom 2011, Department of Health Victoria 2012). There are a total of 8 defined clinical indicators compiled by the Australian Council of Healthcare Standards (ACHS) annually to provide clinical perspectives of trends in service and how to improve quality and safety of care for these patients. Emergency department overcrowding has resulted in the clinical quality indicators of time to analgesia, waiting times, length of stay and mortality becoming adversely affected and having an impact on effectiveness of patient care (Lowthian & Cameron 2012). The quality of patient care in the ED requires continuous monitoring and evaluation, particularly in the context of high demands for ED services, overcrowding and changing national time performance targets. A notable clinical indicator in the ED setting commensurate with quality outcomes is time to analgesia and pain score documentation. Acute pain is the most common precursor for patients presenting to Australian EDs (Kelly & Gunn 2008). A service issue facing the ED today is the abil2141
N. Jennings et al.
ity to deliver timely and effective pain relief. Evaluating the effectiveness of the E-NP service on time to analgesia and pain scores has great implications to provide evidence of quality of patient care. In a joint position statement released by the Australasian College for Emergency Medicine and the College of Emergency Nursing Australasia, pain management is identified as a fundamental component of quality care for ED patients (Australian College of Emergency Medicine 2012). Early and effective pain management in the ED setting may also play a pivotal role in reducing the likelihood of chronic pain syndromes and pain-related anxiety and distress following the acute pain encounter (Weisman et al. 1998, Turturro 2002, Thomas & Shewakramani 2008). Pain persisting for more than 3 months (known as persistent pain) can be debilitating and costly to healthcare services (Williamson et al. 2009). Persistent pain has a significant impact on patients’ physical and mental health and can delay functional recovery following traumatic injury (Mkandawire et al. 2002, Castillo et al. 2006). The development of interventions for the prevention of persistent pain correlates with earlier and more effective treatment of acute pain to reduce or even terminate the progression from acute to persistent pain and improve patient quality of care (Mkandawire et al. 2002, Castillo et al. 2006). Differences in pain scores and treatment effectiveness will be evaluated throughout the study. In 2007, the Australian National Institute of Clinical studies (NICS) sanctioned ‘The NICS National Emergency Care Pain Management Institute’ for the implementation of best practice in relation to ED pain management. As a result, a national audit of 36 hospitals throughout Australia (n = 1996) was conducted and results showed that a median time to analgesia in the ED was 61 minutes, where 30 minutes was considered the national standard by ED care experts (Herd et al. 2009). The study also discovered that less than 40% of patients sampled had a pain score documented at triage. The clinical indicators recommended from the report were a target of 80% of patients presenting to the ED have a documented pain score within 30 minutes, a median time to analgesia of 30 minutes from triage and their Visual Numeric Pain Score (VNPS) reduced by a score of 3 points within 60 minutes of arrival to ED. The major recommendation from the Australian Health Workforce Advisory Committee’s evaluation of ED models of care was the need to address service issues in the ED with innovative models and workforce reform. The developments of innovative models of care have been strategies to address some of these issues. The E-NP role is part of a reformative model of health service that has the potential to have a direct impact on service outcomes and quality of patient care. 2142
The study Aims The aims of this research are to compare the effectiveness of E-NP on service and quality of patient care outcomes, with that of standard care in the ED. Hence, the following null hypotheses will be tested: For patients presenting to the ED with pain, allocated to the fast track zone and who receive care from either an E-NP or standard care, there will be no difference in:
Primary outcomes 1 Pain score reduction and time to analgesia Secondary outcomes 2 Service indicators of • Waiting time • Number of patients who did-not-wait • Length of stay in emergency department • Representations with 48 hours
In addition, a comparative evaluation of clinicians’ use of evidence-based guidelines for management of: (i) knee injury; (ii) ankle injury; and (iii) burns injury will be conducted to further test the integrity of the intervention.
Methodology The nurse practitioner model is distinctive in health service delivery as an innovation that operates from within a nursing paradigm augmented by medical and other health professionals’ skills. The methodological complexities of evaluating NP service relate to the nature of NP service as an intervention that is inherently multidimensional with several interacting elements. Examining this service as a complex intervention will focus the research on patient and service effectiveness and provide an appropriate framework to guide this study. A pragmatic RCT design differs from a traditional RCT in regard to the setting, sample, interventions and the nature and level of research validity. Pragmatic designs are often characterized as having less control over variables, which come at a cost of their internal validity. The design is often reported to have low internal validity due to the limited control in the environment, flexible interventions and the heterogeneous nature of the study sample. Creating a hybrid research design by combining traditional RCT elements (high internal validity) with pragmatic features of © 2014 John Wiley & Sons Ltd
JAN: PROTOCOL
everyday applicability (external validity) produces a balance of methodologies to maximize validity of the research. This is a major strength of this design and is relevant to testing health services innovations, such as E-NP service. The methodological complexities of E-NP service relate to the number of interacting elements in E-NP service as an intervention (Craig et al. 2013). For example, E-NP nursing service is multidimensional incorporating clinical, communication and patient teaching skills in a hybrid nursing/medical service model. The connection between this service intervention and the measurable outcomes is often indirect and difficult to evaluate. This pragmatic design will measure a broad spectrum of patient-centred outcomes to compare effectiveness of interventions in everyday practice of the most common outcomes in the ED setting (Hotopf 2002). Research Ethics Committee approval was gained in December 2013 for commencement scheduled for February 2014.
Study site This is an Australian study that will be conducted in an urban, Emergency and Trauma Centre (hereafter referred to as the ED), in Melbourne, Victoria. The ED is a tertiary public hospital affiliated with several Universities. The hospital has provided emergency services since opening in 1871 and a statewide trauma service since 1989. The current integrated ED facility was commissioned in 1999. In addition to providing emergency services to the local community, the ED also provides Victorian statewide services for: Trauma (adult) and Burns (adult), Hyperbaric Medicine, HIV Medicine, Cystic Fibrosis (adult) and Haemophilia (adult), Heart & Lung Transplant, Critical Neurosurgery. The ED is a purpose-built modern facility consisting of eight Resuscitation and Trauma Bays, nineteen fully monitored general cubicles (including six rapid assessment cubicles) along with six Fast track zone cubicles. In addition, there is also a co-located eighteen-bed Short Stay Unit. The Trauma service treats more than 1200 major traumas annually, which represents greater than half of all major traumas in the state of Victoria, with an estimated annual ED attendance of 65,000 in the year 2012 (Department of Health Victoria 2012). Approximately 30% of these patients are managed in the Fast track zone. The Fast track zone in the ED is a geographical area adjacent to the main ED connected by a corridor. This area is an adjunct to processes in a treatment pathway designated for the timely assessment, treatment and discharge of people seeking primary care for less serious illnesses and © 2014 John Wiley & Sons Ltd
Emergency nurse practitioner
injuries. The six individual cubicles are centred around a staff base station and operate on a 24-hour basis. A multidisciplinary team that may include Registered Nurses, medical officers, registrars, ED consultants, musculoskeletal physiotherapists and E-NPs provides the services in Fast track. Emergency nurse practitioners work in the Fast track zone from 07:00 hours to 23:30 hours on a combination of 8- and 10-hour shifts. All patients presenting to the ED are triaged on arrival and an Australasian Triage Scale (ATS) category allocated (Australian College of Emergency Medicine 2012). The ATS is designed for use in hospital-based emergency services throughout Australia and New Zealand. The ATS is a scale for rating clinical urgency and used to ensure that patients are seen in a time frame that is commensurate with the clinical urgency of their presenting symptoms.
Inclusion/exclusion criteria The study population is all patients presenting to the ED during the sampling time frame and allocated for their episode of care to the Fast Track zone. All eligible patients will be approached by the clinical research assistants using a standardized recruitment script. The eligibility criteria for enrolment in this research are included (Table 1).
Randomization Following collection of baseline data and confirmation of patient eligibility, consenting patients in series will be randomly assigned to either the intervention or the control group by a computer-generated process. The Clinical Research Assistants (CRA) will telephone the offsite randomization service that will allocate study participants using block randomization. Randomization gives each patient a chance of being assigned to either the intervention or control groups. Successful randomization practices require that group assignment cannot be predicted in advance. Block randomization is used to ensure appropriate distribution across the two treatment arms and help reduce bias and confounding, especially when the sample size is small (Efird 2011). Allocation will adhere strictly to the generated sequence with block sizes of four. For every block of four patients, for example, two would be allocated to each arm of the trial (A = intervention and B = control), with block configurations randomly assigned. To strengthen methodological rigour, CRAs and the randomization process will all be independent of other components of the study design. A flow diagram outlining the trial design is shown in Figure 1. 2143
N. Jennings et al.
Table 1 Emergency nurse practitioner (E-NP) trial eligibility criteria. E-NP study Inclusion Criteria Age >16 years Patient presentations ATS 2-5 Pain identified in triage description Exclusion Criteria Non-English-speaking Neurovascular compromise Multiple injuries Altered conscious state including effects of drugs/Ethanol Glasgow Coma Scale
