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Trial registered on ANZCTR


Registration number
ACTRN12625000043437
Ethics application status
Approved
Date submitted
10/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Peripheral intravenous device selection and insertion by a vascular access specialist for hospital inpatients (The PEER Study).
Scientific title
PEripheral intravenous device sElection and insertion by a vasculaR access specialist for hospital inpatients: a randomised controlled trial and embedded feasibility study.
Secondary ID [1] 313544 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The PEER Study
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) 336111 0
Condition category
Condition code
Public Health 332595 332595 0 0
Health service research
Infection 332596 332596 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
A Vascular Access Specialist [VAS] can be defined as a clinician with advanced knowledge in vascular access insertion. This includes device selection; device management in terms of treatment duration and medication administration guidelines, and the use of ultrasound guidance for device placement.

Through evaluation of the patients medical notes/treatment plan, and direct assessment of the patient, the VAS will determine the best device choice. This assessment should take between 10-20 minutes.

The VAS will assess ALL potential participants referred to the study prior to randomisation. At this time the VAS will determine the most appropriate device for the participants needs and this decision will be recorded within clinical trial data files and remain confidential. The participant will then be randomised.

If randomised to intervention, device selection and insertion will be carried out by the VAS and the peripheral intravenous device (per VAS assessment; with/without ultrasound guidance) will be inserted. PIVC device insertion by the VAS will take no longer than device insertion performed as per standard care (no more than 15 minutes).

Post insertion, the PIVC device care will be undertaken as per standard hospital policy. In addition to standard care, the Research Nurse will review both intervention and control participants PIVC sites daily (5 minutes duration) until 48 hours post device removal.

The Research Nurse will also access clinical notes for information relating to PIVC management (i.e. ongoing treatment plan/ complications/ need for device replacement etc). This will take 5-10 minutes daily.

Adherence to the intervention will be assessed under feasibility outcomes.
Intervention code [1] 330134 0
Treatment: Other
Intervention code [2] 330175 0
Treatment: Devices
Comparator / control treatment
Control
If the patient is randomised to standard care, they will receive intravenous 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] 340115 0
Primary feasibility outcome:
The feasibility of conducting a definitive RCT will be assessed as a composite outcome as all criteria need to be met in order for the study to continue. The following criteria established by previous PIVC RCTs will be measured:
1. Eligibility;
2. Recruitment;
3. Retention and attrition;
4. Protocol adherence;
5. Missing data.

If the interim analysis finds feasibility outcomes are being met and there are no safety issues identified with the protocol, the study will continue to recruit (second phase adequately powered RCT). If feasibility outcomes are not being met or safety issues are identified, the study will cease at this time.
Timepoint [1] 340115 0
Eligibility and recruitment will be assessed on recruitment of 100 participants.
Retention and attrition assessed weekly until discharge.
Protocol adherence and missing data will be assessed at the end of the intervention.
Primary outcome [2] 340116 0
Primary clinical outcome:
A composite outcome will be used to determine the primary clinical outcome for this study.
All cause device failure including:
- infiltration/extravasation
- blockage/occlusion (with/without leakage),
- phlebitis (pain/tenderness >2 alone, or in conjunction with one or more of erythema/redness),
- thrombosis,
- dislodgement (complete/partial)
- infection (laboratory-confirmed local/bloodstream infection)
Timepoint [2] 340116 0
Assessed daily from allocated IV device insertion until 48 hours after device removal.
Secondary outcome [1] 442823 0
1. Individual PIVC complications including all cause device failure: a composite of infiltration/extravasation, blockage/occlusion (with/without leakage), phlebitis (pain/tenderness >2 alone, or in conjunction with one or more of erythema/redness), thrombosis, dislodgement (complete/partial) or infection (laboratory-confirmed local/bloodstream infection).
Timepoint [1] 442823 0
Onset at insertion and up until 48 hours post removal of device.
Secondary outcome [2] 443198 0
2. First Insertion Success
Timepoint [2] 443198 0
At the time of insertion
Secondary outcome [3] 443199 0
3. Number of failed insertion attempts;
Timepoint [3] 443199 0
At the time of insertion
Secondary outcome [4] 443200 0
4. Dwell-time (hours) from device insertion to removal;
Timepoint [4] 443200 0
After removal of device
Secondary outcome [5] 443201 0
5. Patient reported pain at device insertion (0-10 rating scale)
Timepoint [5] 443201 0
At the time of insertion

Eligibility
Key inclusion criteria
Inclusion criteria
• Greater than or equal to 18 years of age
• Requiring peripherally compatible intravenous therapy for greater than 24 hours
• Informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Greater than or equal to 18 years of age
• Receiving end-of-life care
• Limited English/ without interpreter
• Inability to consent for self (i.e. cognitive impairment)
• 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)
Using a central, web-based randomisation service, with allocation concealment prior to randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized 1:1 to the VAS or standard care group, with randomly varied block sizes of 4 and 6.
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
RCT data will be exported from REDCap to IBM SPSS version 27 for analysis. If feasibility criteria are met and phase 2 data collection completed, 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. The study will be reported in line with the Consolidated Standards of Reporting Trials (CONSORT) statement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2025
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27384 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 43497 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 318005 0
Charities/Societies/Foundations
Name [1] 318005 0
The Prince Charles Foundation
Country [1] 318005 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Prince Charles Foundation - Common Good Grant
Address
Country
Australia
Secondary sponsor category [1] 320347 0
None
Name [1] 320347 0
Address [1] 320347 0
Country [1] 320347 0
Other collaborator category [1] 283322 0
University
Name [1] 283322 0
University of the Sunshine Coast
Address [1] 283322 0
Country [1] 283322 0
Australia
Other collaborator category [2] 283323 0
Hospital
Name [2] 283323 0
Caboolture Hospital, Metro North Health Service, Queensland Health
Address [2] 283323 0
Country [2] 283323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316666 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 316666 0
Ethics committee country [1] 316666 0
Australia
Date submitted for ethics approval [1] 316666 0
29/08/2024
Approval date [1] 316666 0
22/10/2024
Ethics approval number [1] 316666 0
HREC/2024/MNBB.110165
Ethics committee name [2] 316667 0
University of the Sunshine Coast
Ethics committee address [2] 316667 0
Ethics committee country [2] 316667 0
Australia
Date submitted for ethics approval [2] 316667 0
25/10/2024
Approval date [2] 316667 0
01/11/2024
Ethics approval number [2] 316667 0
A242228

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138590 0
Dr Alison Craswell
Address 138590 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs. Queensland. 4556.
Country 138590 0
Australia
Phone 138590 0
+61 07 5456 3453
Fax 138590 0
Email 138590 0
acraswel@usc.edu.au
Contact person for public queries
Name 138591 0
Alison Craswell
Address 138591 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs. Queensland. 4556.
Country 138591 0
Australia
Phone 138591 0
+61 07 5456 3453
Fax 138591 0
Email 138591 0
acraswel@usc.edu.au
Contact person for scientific queries
Name 138592 0
Alison Craswell
Address 138592 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs. Queensland. 4556.
Country 138592 0
Australia
Phone 138592 0
+61 07 5456 3453
Fax 138592 0
Email 138592 0
acraswel@usc.edu.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 date will be available for this trial due to the conditions of the Human Research Ethics Approval. aggregate cohort data may be released on reasonable request made to the Chief Investigator. This will be assessed on a case by case basis.
De-identified


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.