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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000489695
Ethics application status
Approved
Date submitted
27/04/2023
Date registered
12/05/2023
Date last updated
19/10/2023
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Clinical effectiveness of peripheral intravenous device selection and insertion by a vascular access specialist (The SELECT Study)
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Scientific title
Comparing the clinical effectiveness of peripheral intravenous device selection and insertion by (i) a vascular access specialist (VAS) compared with (ii) any clinician (generalist model): a two-arm superiority randomised controlled trial recruiting medical and surgical inpatients assessing peripherally-placed IV device failure.
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Secondary ID [1]
309529
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None
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Universal Trial Number (UTN)
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Trial acronym
SELECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous device selection and insertion by a vascular access expert
(Short/Long PIVC; Midline Catheter; Peripherally Inserted Central Catheter)
329704
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Condition category
Condition code
Public Health
326604
326604
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0
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Health service research
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Infection
326605
326605
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention arm:
Device selection and insertion (with or without ultrasound guidance) by a Vascular Access Specialist (VAS) of either a short or long-Peripheral Intravenous Catheter (PIVC); Midline catheter (MC) or recommendation/referral for a Peripherally Inserted Central Catheter (PICC).
VAS defined as a clinician with advanced knowledge in vascular access insertion, management, device selection, intravenous therapy management (e.g., treatment duration, peripheral and drug compatibility) and technology guidance (e.g., ultrasound).
Prior to randomisation, all participants will be individually assessed by the VAS to determine the most appropriate IV device for their needs. The VAS will make an expert decision on the type of peripheral intravenous device that would be best suited, keeping the decision confidential. The VAS will then randomise the patient.
If the patient is randomised to “VAS” for device selection and insertion (intervention), the VAS will insert the pre-decided peripheral intravenous device as per their assessment (with or without the use of ultrasound guidance). If, based on the VAS assessment they recommend a PICC as the best option for the patient’s treatment needs, the VAS would make this recommendation to the treating team and assist in the PICC referral process as appropriate.
If the patient is randomised to “generalist” (control), the patient will have an IV device selected and inserted as per current hospital practice by a credentialed clinician or service. These decisions are made at the discretion of the generalist inserter (e.g., bedside nurse or medical team).
All device insertion data will be collected regardless of study allocation (e.g., device type, device location, inserting clinician and number of attempts).
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Intervention code [1]
325875
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Treatment: Other
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Comparator / control treatment
Control arm:
Device selection and insertion by a generalist inserter, including the option to escalate to another clinician or service, as per current hospital practice.
Generalist inserter defined as a clinician who is credentialed as per hospital policy to insert PIVCs within their existing clinical role (e.g., bedside nurse or medical team).
The VAS assessment and device selection prior to randomisation will be collected and recorded but remains confidential until data analysis.
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Control group
Active
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Outcomes
Primary outcome [1]
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Peripherally-placed intravenous (IV) device failure: a composite of infiltration/ extravasation, blockage/occlusion (with/ without leakage), phlebitis, thrombosis, dislodgement or infection (laboratory-confirmed local/bloodstream infection).
Individual measures defined below.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
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Assessment method [1]
334514
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Timepoint [1]
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Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
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Secondary outcome [1]
420963
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Infiltration/extravasation defined as:
the movement of IV fluid/vesicant into surrounding tissue, with or without resulting tissue damage.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
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Assessment method [1]
420963
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Timepoint [1]
420963
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Assessed daily from allocated IV device insertion until removal.
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Secondary outcome [2]
420964
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Blockage/occlusion (with/without leakage) defined as:
IV device will not infuse/flush or leakage occurs when fluids infused/flushed.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
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Assessment method [2]
420964
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Timepoint [2]
420964
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Assessed daily from allocated IV device insertion until removal.
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Secondary outcome [3]
420965
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Phlebitis defined as:
pain score equal or greater than 2 alone; OR two or more signs/symptoms of either: pain/tenderness (score of 1 or more); erythema/redness; swelling or palpable cord.
This information will be collected by the research nurse from either direct observation/patient review, consultation with the clinical staff or review of the medical record.
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Assessment method [3]
420965
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Timepoint [3]
420965
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Assessed daily from allocated IV device insertion until removal.
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Secondary outcome [4]
420968
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Thrombosis defined as:
thrombosed vessel related to the allocated IV device confirmed by ultrasound/venographic imaging.
This will be assessed by either direct observation/patient review, consultation with clinical staff or review of the patient's medical records (including ultrasound/venography findings).
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Assessment method [4]
420968
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Timepoint [4]
420968
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Assessed daily from allocated IV device insertion until removal.
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Secondary outcome [5]
420969
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Dislodgement (partial/complete) defined as:
Partial - change in device length at insertion site, resulting in device removal.
Complete - device completely leaves the vein.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
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Assessment method [5]
420969
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Timepoint [5]
420969
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Assessed daily from allocated IV device insertion until removal.
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Secondary outcome [6]
420970
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Infection: Laboratory-confirmed local infection defined as:
Localised peripheral IV site infection (without bloodstream infection) as per NHSN 2023 CVS-VASC criteria.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of paper medical records, and electronic medical records.
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Assessment method [6]
420970
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Timepoint [6]
420970
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Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
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Secondary outcome [7]
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Infection: bloodstream infection defined as:
Laboratory Confirmed Bloodstream Infection as defined by NHSN 2023 criteria.
For Central Line: in place for 2 days or more.
PIVC and Midline Catheter: must also meet requirement of above laboratory-confirmed local infection.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of paper medical records, and electronic medical records.
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Assessment method [7]
420971
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Timepoint [7]
420971
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Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
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Secondary outcome [8]
420972
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First insertion success (yes/no)
This information will be either self-reported by the VAS/Generalist inserter, patient reported or identified on review of the patient’s medical record.
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Assessment method [8]
420972
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Timepoint [8]
420972
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Assessed at the first insertion attempt of the allocated IV device.
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Secondary outcome [9]
420973
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Number of failed insertion attempts (needle punctures).
This information will be either self-reported by the VAS/Generalist inserter, patient reported or identified on review of the patient’s medical record.
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Assessment method [9]
420973
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Timepoint [9]
420973
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Assessed from randomisation until either:
the allocated IV device is inserted (short/long-PIVC; MC; or PICC);
patient discharged;
or up to a maximum of 7 days after randomisation with no IV device being successfully placed.
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Secondary outcome [10]
420974
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Peripherally-placed IV device dwell-time.
Calculated (in hours) from device insertion until removal.
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of medical record.
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Assessment method [10]
420974
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Timepoint [10]
420974
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Assessed at the time of IV device removal.
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Secondary outcome [11]
420975
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Number and type of IV devices (allocated IV device and any subsequent short/long-PIVC, MC, PICC or other CVADS) needed to complete IV treatment (‘completion’: hospital discharge or no IV device required for 7 days).
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of medical record.
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Assessment method [11]
420975
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Timepoint [11]
420975
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Assessed from randomisation until hospital discharge or no IV device required for 7 days.
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Secondary outcome [12]
420976
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Patient reported pain at device insertion (0-10 verbal rating scale)
Assessed by a Research Nurse, independent to the inserting clinician (VAS or generalist).
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Assessment method [12]
420976
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Timepoint [12]
420976
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Assessed from the time of randomisation until allocated device insertion.
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Secondary outcome [13]
420977
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Patient-reported satisfaction with IV device. The overall satisfaction with the IV device for the duration the device is in situ (0-10 verbal rating scale) and reported against a short questionnaire.
Assessed by a Research Nurse, independent to the inserting clinician (VAS or generalist).
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Assessment method [13]
420977
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Timepoint [13]
420977
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Assessed from allocated IV device insertion up to 48 hours after the device is removed.
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Eligibility
Key inclusion criteria
18 years of age or older
Requiring peripherally-compatible IV therapy for 24 hours or longer
Informed written consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient receiving end-of-life care
Limited English, without appropriate interpreter
Previous study enrolment
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a central, web-based service (1:1) with allocation concealment until commencement of study procedures.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated in a ratio of 1:1 (control to intervention) with permuted block sizes.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary clinical outcome of device failure will be examined using logistic regression with group (generalist/VAS) included as the main effect. It will be reported as odds ratio with 95% confidence interval. Other secondary clinical outcomes will be compared between groups with appropriate parametric or non-parametric techniques. P values <0.05 will be considered significant. Analyses will follow the intention-to-treat principle.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2023
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Actual
17/07/2023
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Date of last participant enrolment
Anticipated
1/12/2023
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Actual
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Date of last data collection
Anticipated
1/02/2024
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Actual
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Sample size
Target
196
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Accrual to date
105
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
40175
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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2023 SERTA Project Grant - RBWH
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Address [1]
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Research and Implementation
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Queensland 4029
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Country [1]
313647
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
Nathan Campus,
170 Kessels Road,
Nathan QLD 4111
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315497
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Country [1]
315497
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Metro North Health Human Research Ethics Committee A
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Ethics committee address [1]
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Metro North Office of Research
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld 4029
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Ethics committee country [1]
312815
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Australia
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Date submitted for ethics approval [1]
312815
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27/02/2023
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Approval date [1]
312815
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27/03/2023
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Ethics approval number [1]
312815
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HREC/2023/MNHA/91818
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Summary
Brief summary
Peripheral Intravenous Catheters (PIVCs) are the most frequently used vascular access device in Australia, with Queensland Health spending $41 million purchasing over 2.6 million PIVCs in 2016 alone. Currently, peripheral intravenous (IV) device choice consistently defaults to short-PIVCs (<4cms) to meet most patients’ IV treatment needs. This is largely due to the current workforce model in which most PIVC inserters are doctors and nurses (generalist) inserting PIVCs within their existing roles.
Over the last decade, PIVC insertion teams made up of Vascular Access Specialists (VAS) have been disbanded in many hospitals due to budgetary constraints. The ‘generalist’ approach has been adopted instead putting pressure on already-stretched frontline clinicians, particularly junior medical officers in the after-hours space. Inherent inefficiencies in the current generalist workforce model are not sustainable. More efficient, innovative service provision is urgently needed.
Our research project aims to compare the clinical effectiveness of peripheral intravenous device selection and insertion by (i) VAS compared with (ii) generalist model (standard practice). We will conduct a single-centre, two-arm, parallel, randomised controlled trial recruiting 196 patients who are 18 years of age or older and requiring IV therapy for 24hrs or more.
All participants enrolled in this trial will be randomly allocated (by chance) to have their IV device inserted by either a VAS or a generalist inserter. Daily follow up checks will then be carried out by a (blinded) Research Nurse until the time of device removal.
We the investigators hypothesise that devices selected and inserted by a VAS, compared to those inserted by a generalist inserter, will result in:
• Reduced peripheral IV device failure and complications
• Fewer attempts to achieve successful peripheral IV device placement
• Fewer devices to complete the prescribed peripheral IV therapy
• Improved patient satisfaction and less self-reported pain on insertion
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Nicole Marsh
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Address
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Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
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Country
126014
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Australia
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Phone
126014
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+61 7 3646 8740
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Fax
126014
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Email
126014
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[email protected]
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Contact person for public queries
Name
126015
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Prof Nicole Marsh
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Address
126015
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Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
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Country
126015
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Australia
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Phone
126015
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+61 7 3646 8740
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Fax
126015
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Email
126015
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[email protected]
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Contact person for scientific queries
Name
126016
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Prof Nicole Marsh
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Address
126016
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Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
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Country
126016
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Australia
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Phone
126016
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+61 7 3646 8740
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Fax
126016
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Email
126016
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No individual participant data will be available for this trial due to Human Research Ethics Committee approved conditions.
De-identified aggregate cohort data may be released on reasonable request made to the Chief Investigator. This will be assessed on a case by case basis.
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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.
Download to PDF