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Trial registered on ANZCTR


Registration number
ACTRN12616001675415
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
6/12/2016
Date last updated
27/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliable Intravenous Access by Line Experts (RELIABLE): a pilot trial
Scientific title
Reliable Intravenous Access by Line Experts (RELIABLE): a pilot randomised controlled trial to compare peripheral venous catheter insertion by vascular access specialists with any clinician (generalist model, standard practice) on clinical and economic outcomes among medical and surgical patients.
Secondary ID [1] 290308 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The RELIABLE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure prior to completion of therapy. 300563 0
Condition category
Condition code
Public Health 300420 300420 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients from the medical and surgical departments who require a peripheral intravenous catheters (PVC) for longer than 24 hours will be eligible for inclusion in this study. Consenting patients will have their PVC inserted by a Vascular Access Specialist (intervention) or a generalist clinician (control).

Arm 1 (control): PVC inserted as per hospital policy by a credentialed PVC inserter (generalist approach).
Arm 2 (intervention): Vascular Access Specialist (VAS), defined as a registered nurse with advanced knowledge of vascular access including catheter technology, dressings, modalities of catheter access and intravenous therapy management.

Intervention code [1] 296119 0
Prevention
Intervention code [2] 296120 0
Treatment: Other
Comparator / control treatment
Control group patients will have their PVC inserted as per hospital policy by a credentialed PVC inserter (generalist approach).
Control group
Active

Outcomes
Primary outcome [1] 299909 0
The primary outcomes is to establish the feasibility of conducting an adequately powered randomised controlled trial in the future. Feasibility measures will include: patient eligibility (more than 90% of those screened); consent (more than 90% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); and retention (less than 5% of enrolled patients lost to follow up).
Timepoint [1] 299909 0
At the time of trial completion.
Secondary outcome [1] 328490 0
Phlebitis: Defined as 2 or more of pain, redness, swelling, palpable cord or purulent discharge.

Timepoint [1] 328490 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [2] 328491 0
Infiltration and Extravasation: Defined as the movement of IV fluids into the surrounding tissue with/without resulting tissue breakdown.
Timepoint [2] 328491 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [3] 328492 0
Occlusion: Defined as the PVC will not infuse, or leakage occurs when fluid is infused.
Timepoint [3] 328492 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [4] 328493 0
Dislodgement (either partial or total):
Partial - Change in PVC length at insertion site (inner catheter visible).
Total - PVC completely leaves the vein.
Timepoint [4] 328493 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [5] 328495 0
Infection (laboratory confirmed local or bloodstream infection): PVC skin swabs, PVC tip and blood cultures may be collected as per usual clinical practice if clinical suspicion of local infection or systemic infection.
Timepoint [5] 328495 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [6] 328496 0
PVC dwell time: from the time of PVC insertion until removal from either device failure, routine replacement or the completion of IV therapy.
Timepoint [6] 328496 0
At the time of PVC removal.
Secondary outcome [7] 328497 0
Cost effectiveness: estimates of costs of staff resources, equipment and PVC failure resource usage with previously developed cost estimations. Detailed resources used for a PVC insertion and removal will be recorded for a subset of 15 patients per study group.
Timepoint [7] 328497 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [8] 328498 0
Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [8] 328498 0
At the time of PVC insertion and removal.
Secondary outcome [9] 337887 0
Failure to successful place a PVC within 24 hours of request for PVC insertion
Timepoint [9] 337887 0
At the time of PVC insertion or within 24 hours of randomisation
Secondary outcome [10] 337888 0
Total number of insertion attempts (as determined by documentation, staff and patient reporting)
Timepoint [10] 337888 0
At time of PVC insertion or within 24 hours of randomisation

Eligibility
Key inclusion criteria
Patient requires a PVC for greater than 24 hours
=>the age of 18 (no upper limit)
Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current blood stream infection (within 48 hours of study entry).
Previous enrolment on the study.
Patients on a palliative care pathway and/or receiving critical care treatment.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Randomisation will be in a 1:1 ratio between the two study groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria, e.g. <5% missing data. As a pilot study, statistical comparison methods will be used for piloting purposes only. Descriptive statistics will be used to describe the sample. Mean values and standard deviations (SD) will be reported for normally distributed data; median values and 25th/75th percentiles reported otherwise. Cox regression will be used to assess the effect of patients and treatment differences as well as for group comparisons. A graph of the Kaplan-Meier survival function will be generated, and the proportional hazards assumption checked with the log-log plot of survival, and log-rank test performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6840 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14505 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 294732 0
University
Name [1] 294732 0
Griffith Univeristy
Address [1] 294732 0
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country [1] 294732 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 293577 0
None
Name [1] 293577 0
Address [1] 293577 0
Country [1] 293577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296149 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 296149 0
Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, QLD, Australia, 4029
Ethics committee country [1] 296149 0
Australia
Date submitted for ethics approval [1] 296149 0
26/08/2016
Approval date [1] 296149 0
22/09/2016
Ethics approval number [1] 296149 0
HREC/16/QRBW/386
Ethics committee name [2] 296151 0
Griffith University
Ethics committee address [2] 296151 0
Office for Research,
Griffith University,
Nathan Campus,
170 Kessels Rd,
Nathan, QLD, Australia, 4111
Ethics committee country [2] 296151 0
Australia
Date submitted for ethics approval [2] 296151 0
23/09/2016
Approval date [2] 296151 0
10/10/2016
Ethics approval number [2] 296151 0
2016/782

Summary
Brief summary
Successful peripheral venous catheter (PVC) insertion and the decrease of catheter related complications that result in device failure is an important clinical objective and patient outcome. Although previous studies have identified the level of skill of the PVC inserter as a risk factor for catheter failure there is a paucity of information investigating the impact of a Vascular Access Specialist (VAS).

We will use a single centre, randomised controlled trial to compare the clinical and economic outcomes of PVC inserted by a VAS against those inserted by a generalist inserter (standard care). As this is a pilot study, the primary aim of this study is to establish feasibility of the protocol and the planned processes. This will help to budget and plan correctly for the larger definitive trial. We will collect data on the success of screening and recruitment strategies; test our data collection processes and technology; cost the Research Nurse time required for the trial; and finalise sample size requirements for the larger trial.
Participants will be eligible for inclusion in this trial if they are a medical or surgical patient over the age of 18 and are having a peripheral intravenous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours).

All participants enrolled in this trial will be randomly allocated (by chance) to have their PVC inserted by either a Vascular Access Specialist or a generalist inserter. Daily follow ups will then be carried out by a (blinded) Research Nurse until the time of device removal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67706 0
Ms Nicole Marsh
Address 67706 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 67706 0
Australia
Phone 67706 0
+61 7 3646 8740
Fax 67706 0
Email 67706 0
nicole.marsh@health.qld.gov.au
Contact person for public queries
Name 67707 0
Ms Nicole Marsh
Address 67707 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 67707 0
Australia
Phone 67707 0
+61 7 3646 8740
Fax 67707 0
Email 67707 0
nicole.marsh@health.qld.gov.au
Contact person for scientific queries
Name 67708 0
Ms Nicole Marsh
Address 67708 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 67708 0
Australia
Phone 67708 0
+61 7 3646 8740
Fax 67708 0
Email 67708 0
nicole.marsh@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary