ANZCTR - Registration

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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]

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.

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

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]

At the time of trial completion.

Secondary outcome [1]

Phlebitis: Defined as 2 or more of pain, redness, swelling, palpable cord or purulent discharge.

Timepoint [1]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [2]

Infiltration and Extravasation: Defined as the movement of IV fluids into the surrounding tissue with/without resulting tissue breakdown.

Timepoint [2]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [3]

Occlusion: Defined as the PVC will not infuse, or leakage occurs when fluid is infused.

Timepoint [3]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [4]

Dislodgement (either partial or total):
Partial - Change in PVC length at insertion site (inner catheter visible).
Total - PVC completely leaves the vein.

Timepoint [4]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [5]

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]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [6]

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]

At the time of PVC removal.

Secondary outcome [7]

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]

Daily from PVC insertion until the time of PVC removal.

Secondary outcome [8]

Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.

Timepoint [8]

At the time of PVC insertion and removal.

Secondary outcome [9]

Failure to successful place a PVC within 24 hours of request for PVC insertion

Timepoint [9]

At the time of PVC insertion or within 24 hours of randomisation

Secondary outcome [10]

Total number of insertion attempts (as determined by documentation, staff and patient reporting)

Timepoint [10]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/04/2017

Actual

21/07/2017

Date of last participant enrolment

Anticipated

29/09/2017

Actual

10/11/2017

Date of last data collection

Anticipated

6/10/2017

Actual

15/11/2017

Sample size

Target

100

Accrual to date

Final

138

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith Univeristy

Address [1]

Nathan Campus
170 Kessels Road,
Nathan QLD, 4111

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Nathan Campus
170 Kessels Road,
Nathan QLD, 4111

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston, QLD, Australia, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/08/2016

Approval date [1]

22/09/2016

Ethics approval number [1]

HREC/16/QRBW/386

Ethics committee name [2]

Griffith University

Ethics committee address [2]

Office for Research,
Griffith University, 
Nathan Campus,
170 Kessels Rd, 
Nathan, QLD, Australia, 4111

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/09/2016

Approval date [2]

10/10/2016

Ethics approval number [2]

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

Ms Nicole Marsh

Address

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

Australia

Phone

+61 7 3646 8740

Fax

nicole.marsh@health.qld.gov.au

Contact person for public queries

Name

Nicole Marsh

Address

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

Australia

Phone

+61 7 3646 8740

Fax

nicole.marsh@health.qld.gov.au

Contact person for scientific queries

Name

Nicole Marsh

Address

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

Australia

Phone

+61 7 3646 8740

Fax

nicole.marsh@health.qld.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Expert versus generalist inserters for peripheral intravenous catheter insertion: A pilot randomised controlled trial.	2018	https://dx.doi.org/10.1186/s13063-018-2946-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically