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Trial registered on ANZCTR


Registration number
ACTRN12613000933752
Ethics application status
Not yet submitted
Date submitted
16/08/2013
Date registered
23/08/2013
Date last updated
23/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
To measure the effectiveness of Emergency nurse practitioners on service and quality of patient care outcomes for patients in the Emergency department compared with standard emergency medical care.
Scientific title
A randomised controlled trial to measure the effectiveness of emergency nurse practitioners on service and quality of patient care outcomes compared with standard emergency medical care in adult patients presenting to the Emergency department and allocated to the fast treatment zone.
Secondary ID [1] 283028 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain in the emergency department 289860 0
Condition category
Condition code
Injuries and Accidents 290220 290220 0 0
Other injuries and accidents
Public Health 290221 290221 0 0
Health service research
Anaesthesiology 290253 290253 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For patients presenting to the emergency department with Pain, following collection of baseline data and the eligibility of the patient is confirmed; consenting patents in series will be randomly assigned to either the intervention or the control group by a computer-generated program. The intervention to be evaluated in this research will be emergency nurse practitioner (E-NP) service. The emergency nurse practitioner model of care specifically includes assessment and management of patients using critical decision-making skills, referring directly to other health care providers, prescribing medications, performing interventions, ordering and interpreting diagnostic investigations and admission/discharging autonomy. The E-NP will assess the next available patient within their scope of practice according to time waiting to be seen as per usual ED policy. After this initial assessment the E-NP will commence management of the patient and complete the episode of care. The duration of the intervention will be from initial patient assessment until discharge from the ED. The service is geographically located in the Fast track area of the ED and the E-NP manages patients presenting with ATS categories 2-5 (Australian College of Emergency Medicine, 2012).
Intervention code [1] 287750 0
Other interventions
Comparator / control treatment
The study control will be standard ED care, which is operationally defined as medical officer managed care with assistance from registered nurses. Medical officers covering the fast track zone are emergency medicine registrars with a minimum of 3 years post basic training and are currently undertaking advanced training to be registered as a fellow of the Australian College of Emergency Medicine. Standard ED care will be practiced in accordance with usual ED policy with no changes to the model. The patient is allocated to the Fast track zone and the next available clinician will commence the initial assessment. The registered nurse or the medical officer may undertake this initial assessment but management decisions will be made by the medical officer and then completed by the standard ED care team members in the Fast track zone.
Control group
Active

Outcomes
Primary outcome [1] 290244 0
Pain score measurement.
Timepoint [1] 290244 0
Pain scores measured on arrival, following analgesia and on discharge from the ED using a Verbal numeric pain score.
Primary outcome [2] 290271 0
Time to analgesia
Timepoint [2] 290271 0
Time to analgesia measurement and ability to reach target of 30 minutes from arrival , measured in minutes. Initial registration of the patient on the electronic health record until written prescription by practitioner on medication chart.
Secondary outcome [1] 304191 0
Waiting times
Timepoint [1] 304191 0
Waiting time will be defined as time in minutes from initial registration until treatment commencement by the managing practitioner.
Secondary outcome [2] 304192 0
The utilisation of evidenced based guidelines for the management of ankles, knees and burn injuries.
Timepoint [2] 304192 0
On discharge from ED Care as recorded in patients electronic record.
Secondary outcome [3] 304230 0
Length of stay
Timepoint [3] 304230 0
Length of stay will be defined as the time in minutes the patient spends in the ED from initial registration until time of disposition from the ED. Initial registration on electronic health record until discharge from the ED
Secondary outcome [4] 304231 0
Number of representations within 48 hours
Timepoint [4] 304231 0
The representation variable will be defined as any patient enrolled in the study that represents with the same presenting complaint to the ED within 48 hours of disposition.
Secondary outcome [5] 304232 0
Percentage of patients whom do not wait for treatment
Timepoint [5] 304232 0
Patients who did not wait will be defined as those who register for treatment and are seen by the triage nurse but then leave the ED before commencement of treatment.

Eligibility
Key inclusion criteria
Age >16 years
Patient presentations ATS 2-5
Pain identified in triage description
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking
Neurovascular compromise
Multiple injuries
ACS including effects of drugs/ Ethanol
GCS <14
Fulfils inclusion criteria but requires ED medical management

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will be given study information and consent documents and invited to participate in the study. The information document will describe the purpose of the study, the procedures to be followed, and the risks and benefits of participation. Prior to enrolling in the study a signed consent form will be obtained for each patient. The CRA will conduct the informed consent discussion and will check that the patient and their legally acceptable representative comprehend the information provided and answer any questions about the study. Consent will be voluntary and free from coercion.
The CRA will recruit patients, collect baseline data and allocate patients according to the generated random block allocation sequence performed by the Lead Researcher. The CRA will be trained in methods of consent, data collection and protocol for contacting the Lead Researcher for (blinded) randomization allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following collection of baseline data and the eligibility of the patient is confirmed; consenting patents in series will be randomly assigned to either the intervention or the control group by a computer-generated program. The Clinical Research Assistants (CRA) will telephone the primary researcher who will allocate study participants using a block randomisation process. Randomisation gives each patient a chance of being assigned to either the intervention or control groups. Successful randomisation practices require that group assignment cannot be predicted in advance. Block randomisation is used to ensure appropriate distribution across the two treatment arms and help to reduce bias and confounding, especially when the sample size is small. Allocation will adhere strictly to the generated sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pragmatic randomised control trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Differences in pain scores and effectiveness will be evaluated throughout the study. In 2007, the NHMRC 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 sampled and results showed that a median time to analgesia in the ED was 61minutes, where 30 minutes was considered the national standard by ED care experts (Herd, Babl, Gilhorta, & Huckson, 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 VNPS reduces by a score of 3 points within 60 minutes of arrival to ED.
The main purpose of the study will be to detect differences between the two intervention groups in relation to time to analgesia and pain scores. As per the defined national standard of best practice in relation to time to analgesia in the ED (National Health and Medical Research Council, 2011), the primary outcome is whether or not analgesia was administered within 30 minutes of arrival. A 20% change of compliance with the 30 minute standard between the two groups was considered to be clinically important. Sample size calculations will be based on 80% power and a type 1 error rate (two sided) of 0.05 and adjusted for an estimated loss to follow-up of 20%. Consequently the sample size was calculated to total 260 patients; 130 patients per arm of the study. The 30 minute ‘Target Achieved’ variable will be considered as binary (yes/no for achieving the target time of 30 minutes). The difference in "time to analgesia" tested by t-test or Wilcoxon Rank Sum depending upon the distribution. Utilising 30 minutes as best practice for time to analgesia for patients presenting with pain to the ED, we felt a difference of 20% between the two groups to be clinically important. We anticipate a male to female ratio of 3: 2 which reflects the over representation of males presenting with minor to moderate painful traumatic injury and is consistent with the gender ratio previously reported in similar patient cohorts and study 1 results.
Did not wait presentations will be identified by the routine ICD-10-AM disposition code (Statistical classification of Diseases and Related Health Problems, 10th Revision, Australian Modification) on the ED patient information system/electronic heath record by the ORA. Representations within 48 hours will be hand searched though the enquiry ability of the electronic patient record system by the ORA.
A comparison style study will also be conducted examining the comparative use of use of EBG in everyday practice. The patients whom are treated for ankle, knee or burns injury will be selected and compared with the intervention. The patients’ electronic health record will be audited to determine if EBG were used and documented in their treatment decisions in their ED care.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
15/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1443 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7278 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 287792 0
Self funded/Unfunded
Name [1] 287792 0
Natasha Jennings
Country [1] 287792 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 286521 0
Hospital
Name [1] 286521 0
The Alfred
Address [1] 286521 0
Commercial Road
Prahran
Victoria,
3181
Country [1] 286521 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289739 0
Alfred Research and Ethics commitee
Ethics committee address [1] 289739 0
Commercial Road
Prahran
Victoria,
3181
Ethics committee country [1] 289739 0
Australia
Date submitted for ethics approval [1] 289739 0
21/09/2013
Approval date [1] 289739 0
Ethics approval number [1] 289739 0

Summary
Brief summary
The aims of this research are to compare the effectiveness of Emergency Nurse Practitioner (E-NP) on service and quality of patient care outcomes, with that of standard care in the Emergency Department (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
a) Waiting time
b) Number of patients who did-not-wait
c) Length of stay in emergency department
d) 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42194 0
Mrs Natasha Jennings
Address 42194 0
The Alfred Hospital
Emergency and Trauma Centre
PO BOX 315
Prahran, Victoria, 3181
Country 42194 0
Australia
Phone 42194 0
+61 03 9076 3405
Fax 42194 0
Email 42194 0
[email protected]
Contact person for public queries
Name 42195 0
Natasha Jennings
Address 42195 0
The Alfred Hospital
Emergency and Trauma Centre
PO BOX 315
Prahran, Victoria, 3181
Country 42195 0
Australia
Phone 42195 0
+61 03 9076 3405
Fax 42195 0
Email 42195 0
[email protected]
Contact person for scientific queries
Name 42196 0
Gerard Oreilly
Address 42196 0
The Alfred Hospital
Emergency and Trauma Centre
PO BOX 315
Prahran, Victoria, 3181
Country 42196 0
Australia
Phone 42196 0
+61 03 9076 3405
Fax 42196 0
Email 42196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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