Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
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.
Secondary ID [1] 309529 0
None
Universal Trial Number (UTN)
Trial acronym
SELECT
Linked study record

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 0
Condition category
Condition code
Public Health 326604 326604 0 0
Health service research
Infection 326605 326605 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 325875 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 334514 0
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.
Timepoint [1] 334514 0
Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
Secondary outcome [1] 420963 0
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.
Timepoint [1] 420963 0
Assessed daily from allocated IV device insertion until removal.
Secondary outcome [2] 420964 0
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.
Timepoint [2] 420964 0
Assessed daily from allocated IV device insertion until removal.
Secondary outcome [3] 420965 0
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.
Timepoint [3] 420965 0
Assessed daily from allocated IV device insertion until removal.
Secondary outcome [4] 420968 0
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).
Timepoint [4] 420968 0
Assessed daily from allocated IV device insertion until removal.
Secondary outcome [5] 420969 0
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.
Timepoint [5] 420969 0
Assessed daily from allocated IV device insertion until removal.
Secondary outcome [6] 420970 0
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.
Timepoint [6] 420970 0
Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
Secondary outcome [7] 420971 0
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.
Timepoint [7] 420971 0
Assessed daily from allocated IV device insertion until 48 hours after the device is removed.
Secondary outcome [8] 420972 0
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.
Timepoint [8] 420972 0
Assessed at the first insertion attempt of the allocated IV device.
Secondary outcome [9] 420973 0
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.
Timepoint [9] 420973 0
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.
Secondary outcome [10] 420974 0
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.
Timepoint [10] 420974 0
Assessed at the time of IV device removal.
Secondary outcome [11] 420975 0
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.
Timepoint [11] 420975 0
Assessed from randomisation until hospital discharge or no IV device required for 7 days.
Secondary outcome [12] 420976 0
Patient reported pain at device insertion (0-10 verbal rating scale)

Assessed by a Research Nurse, independent to the inserting clinician (VAS or generalist).
Timepoint [12] 420976 0
Assessed from the time of randomisation until allocated device insertion.
Secondary outcome [13] 420977 0
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).
Timepoint [13] 420977 0
Assessed from allocated IV device insertion up to 48 hours after the device is removed.

Eligibility
Key inclusion criteria
18 years of age or older
Requiring peripherally-compatible IV therapy for 24 hours or longer
Informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient receiving end-of-life care
Limited English, without appropriate interpreter
Previous study enrolment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
17/07/2023
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
196
Accrual to date
105
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24579 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40175 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 313647 0
Hospital
Name [1] 313647 0
2023 SERTA Project Grant - RBWH
Country [1] 313647 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 315497 0
None
Name [1] 315497 0
Address [1] 315497 0
Country [1] 315497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312815 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 312815 0
Metro North Office of Research
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld 4029
Ethics committee country [1] 312815 0
Australia
Date submitted for ethics approval [1] 312815 0
27/02/2023
Approval date [1] 312815 0
27/03/2023
Ethics approval number [1] 312815 0
HREC/2023/MNHA/91818

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126014 0
Prof Nicole Marsh
Address 126014 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 126014 0
Australia
Phone 126014 0
+61 7 3646 8740
Fax 126014 0
Email 126014 0
nicole.marsh@health.qld.gov.au
Contact person for public queries
Name 126015 0
Prof Nicole Marsh
Address 126015 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 126015 0
Australia
Phone 126015 0
+61 7 3646 8740
Fax 126015 0
Email 126015 0
nicole.marsh@health.qld.gov.au
Contact person for scientific queries
Name 126016 0
Prof Nicole Marsh
Address 126016 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 126016 0
Australia
Phone 126016 0
+61 7 3646 8740
Fax 126016 0
Email 126016 0
nicole.marsh@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.