Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000930280
Ethics application status
Not yet submitted
Date submitted
28/10/2009
Date registered
28/10/2009
Date last updated
28/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergency department fast track: a randomised control trial of physician versus nurse-based care
Scientific title
Randomised control trial of physician versus nurse practitioner based care on patient satisfaction and health outcomes in emergency department fast track patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Minor injuries and conditions presenting to an emergency department fast track unit 252071 0
Condition category
Condition code
Public Health 252276 252276 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a dedicated emergency department nurse practitioner working in the fast track unit over a 4 month period
Intervention code [1] 241465 0
Other interventions
Comparator / control treatment
Patients treated with emergency department doctors over a 4 month period
Control group
Active

Outcomes
Primary outcome [1] 253146 0
Mean patient satisfaction score using a standardised patient satisfaction rating intrument
Timepoint [1] 253146 0
upon completion of consultation
Secondary outcome [1] 262045 0
health outcome using SF12 (acute recall)
Timepoint [1] 262045 0
2 weeks post Emergency Department (ED) discharge

Eligibility
Key inclusion criteria
Adult patients (age > 16 years) who are triaged to the fast track unit between 0800-2230
Normal vital signs and mental state
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple medical comorbidities
Dementia
Unable to provide a reliable history or follow up

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)
Patients are identified and enrolled through the emergency department triage nurse. A sealed envelope in a box is obtained that contains the study group allocation. This is opened by the triage nurse and placed in the patient notes in the fast track area without being revelaed to the patient
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The group allocation will be assigned using a computer random number generator and will be placed randomly in box
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243937 0
Self funded/Unfunded
Name [1] 243937 0
NA
Country [1] 243937 0
Primary sponsor type
Hospital
Name
The Canterbury Hospital, Emergency Department
Address
Canterbury Rd, Campsie NSW 2194
Country
Australia
Secondary sponsor category [1] 251292 0
None
Name [1] 251292 0
NA
Address [1] 251292 0
NA
Country [1] 251292 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244050 0
Human Research Ethics Committee Sydney South West Area Health Service (central zone)
Ethics committee address [1] 244050 0
Research Development office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Ethics committee country [1] 244050 0
Australia
Date submitted for ethics approval [1] 244050 0
28/10/2010
Approval date [1] 244050 0
Ethics approval number [1] 244050 0

Summary
Brief summary
The objective of the study is to evaluate an alternative model of care using a nurse practitioner for patients presenting to emergency departments with minor conditions. The hypothesis is that patients with minor conditions seen initially by nurse practitioners are more satisfied with their care compared to those seen initially by an emergency department doctor. The hypothesis will be tested using a randomised controlled trial study design.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30428 0
Address 30428 0
Country 30428 0
Phone 30428 0
Fax 30428 0
Email 30428 0
Contact person for public queries
Name 13675 0
Dr Michael Dinh
Address 13675 0
Emergency Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 13675 0
Australia
Phone 13675 0
+61 2 9515 6111
Fax 13675 0
Email 13675 0
[email protected]
Contact person for scientific queries
Name 4603 0
Dr Michael Dinh
Address 4603 0
Emergency Department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 4603 0
Australia
Phone 4603 0
+61 2 9515 6111
Fax 4603 0
Email 4603 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.