ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000089336

Ethics application status

Approved

Date submitted

10/01/2017

Date registered

17/01/2017

Date last updated

17/09/2020

Date data sharing statement initially provided

5/04/2019

Date results information initially provided

17/09/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Integrated versus nOn-integrated Peripheral inTravenous catheter in adult hospitalised patients. Which Is the most clinical and cost-effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM randomised controlled trial)

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1191-4336

Trial acronym

The OPTIMUM Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Clinical and cost-effectiveness of two peripheral intravenous catheter (PIVC) systems to prevent peripheral intravenous catheter complications and failure.

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Two-arm randomised controlled trial including 2200 adults (18yrs and older) patients. Prospective patients scheduled to have a PIVC inserted and meet the inclusion criteria will be invited to participate.

Arm 1: The BD Nexiva closed IV catheter system is an integrated PIVC system. BD Nexiva consists of a number of key components incorporated as one piece: IV catheter, stabilization platform, finger grips, needle safety shield, extension tubing, pinch clamp, Y adapter (double port catheter), and vent plug. The Nexiva catheter is available in a range of sizes from 18 up to 24 gauge and as a single or double port. In this study, the double port will be used; therefore two BD SmartSite connectors will be added to close the Y-connector completely (1100 participants).

Arm 2: The traditional non-integrated system is different to the integrated system in that all the components are separated pieces, which need to be attached during cannulation. In this study, the B Braun Introcan Safety 3 or BD Insyte Autoguard catheter will be used. Key components of this catheter are: IV catheter, needle, transparent catheter hub, push-off plate, flashback chamber, removable vented flashplug, safety mechanism (to cover the needle tip). A Connecta extension set 15cm with SmartSite connector/s will be attached to the catheter (1100 participants).

Insertion and care of the PIVCs: Study and control catheters will be inserted by trained clinicians at each hospital, who are existing skilled or competent IV inserters. Pre-trial they will have training and simulated practice inserting the study catheter until they feel confident that their skills are at the same level as the control catheter insertion. The training will be provided by a Research Fellow and a Clinical Nurse (both specialists in vascular access devices), and will consist of a single 3-hour workshop with a maximum of six participants. During the training, educative videos with content on the characteristics of the integrated system, insertion techniques, dressing, care, and removal of the device will be shown, followed by a discussion on the main differences between the non-integrated and the integrated systems as well as a Q&A section. After the theoretical content is delivered, clinicians will practice the insertion of the device on insertion arms until they feel equally confident using the integrated catheter (level of confidence >80%). We anticipate 15-20 successful insertions will be sufficient.

Patients will have a single PIVC entered into the study. As PIVCs can fail at any time of day and need to be replaced quickly, it is not possible to have subsequent insertions for that patient follow the study protocol. This is because the general hospital staff would not be trained in integrated PIVC insertion. Once patients have a failed PIVC, they will receive the standard institutional PIVC inserted by the hospital staff, and are no longer on the trial. During the trial, patients will have other aspects of PIVC care standardised in all study groups, consistent with usual practice. The devices will remain in situ as per hospital policy.
All other PIVC insertion and care practices will be as per individual site policy e.g. skin preparation, dressings, etc,

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Non-integrated system: B Braun Introcan Safety 3 or BD Insyte Autoguard catheter, Conneta extension set 15cm, with SmartSite connector/s.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is PIVC failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter-related infections. a) Occlusion is defined as the inability to infuse or inject solution into a catheter. b) Infiltration/extravasation infiltration is defined as the inadvertent permeation of IV fluid (non-vesicant solution) into the interstitial compartment, causing swelling of the tissue around the site of the catheter. Extravasation is the inadvertent administration of a vesicant solution into surrounding tissue. c) Phlebitis/thrombophlebitis phlebitis is defined as irritation and inflammation of a vein wall caused by the presence of the PIVC. It is characterised by the presence of any combination of tenderness, pain, erythema, swelling, warmth, palpable cord, or purulent drainage. In this study phlebitis includes pain (>1 out of 10) alone or plus any of the criteria mentioned above (on questioning, then palpation by the research nurse). Thrombophlebitis is also characterised by a visible clot on removal and/or palpable thrombosis of the cannulated vein. All these are consequence of the inflammation of the vein wall that leads to thrombus formation. In this study the presence of thrombophlebitis will be confirmed by ultrasound of the compromised vessel (if ordered by clinicians). d) Dislodgement is defined as movement of the catheter in and out of, or around and within, the vein resulting in partial or complete dislodgement. This may be characterized as Leaking (partial dislodgement). e) Haematoma is defined as solid swelling of clotted blood within the tissue, caused by a break in the wall of the blood vessel due to the insertion of a PIVC, resulting in device malfunction and triggering the removal of the catheter.' f) Localised venous infection is defined as organisms grown from purulent discharge or vein segment with no evidence of associated bloodstream infection. g) Bloodstream infection is defined as positive blood culture from a peripheral vein; clinical signs of infection (i.e. fever, chills, or hypotension); no other apparent source for the bloodstream infection except the intravenous catheter (in situ within 48 h of the bloodstream infection); and either a colonised intravenous catheter tip culture with the same organism as identified in the blood or purulent drainage from the involved vascular site.

Timepoint [1]

Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.

Secondary outcome [1]

Failure type (occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter-related infections)

Timepoint [1]

Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.

Secondary outcome [2]

Device colonisation: From the Qld site, approximately 468 (234 per group) PIVC tips will be analysed by the semi-quantitative method in the Griffith University laboratory. PIVC tips will be selected based on availability of the Research Nurse when the PIVC is removed and when transfer to the lab is available. Colonisation of intravenous catheter tip will be considered if more than 15 colony-forming units are present. Blood cultures from a peripheral vein, and PIVC skin swabs (if ordered by clinicians) will be cultured by Microbiology Pathology Queensland-Central Lab by blinded scientists

Timepoint [2]

24-76 hours after catheter removal

Secondary outcome [3]

Insertion pain (NRS 0=no pain, 10=extreme pain)

Timepoint [3]

Right after catheter insertion

Secondary outcome [4]

Dwell time without complications
The Research Nurse will visit the participants once a day and perform a clinical assessment of the IV catheter, and record the information using ReDCap (Vanderbilt) software on hand-held devices.
For participants whose IV catheter was removed overnight, review of the hospital records will be performed.

Timepoint [4]

Clinical assessment will be performed daily and upon catheter removal.

Secondary outcome [5]

Adverse events such as infection or death. Clinical assessment will be performed daily and 48 hours after catheter removal. In addition, review of hospital records will be perform in case of death to determine if it was associated with the IV catheter.

Timepoint [5]

During the the dwell of the catheter and up to 48 hours of catheter removal

Secondary outcome [6]

Mortality

Timepoint [6]

During the the dwell of the catheter and up to 48 hours of catheter removal. Revision of hospital records will be performed to determine if the cause of death was associated to the catheter.

Secondary outcome [7]

Cost-effectiveness:
We will quantify additional costs, benefits, net monetary benefit, considering PIVCs indwelling time, reinsertions and treatment costs of complications/group. Cost-analyses using ANCOVA will be undertaken to compare group costs. P-values <0.05 will be statistically significant.

Timepoint [7]

One month after completion of study

Secondary outcome [8]

Learning curve for integrated IV system clinicians who are current specialist or competent inserters will be trained on using the integrated PIVC system. Number of simulated insertions, and/or clinical insertions, for clinicians to feel >80% and >90% confidence for 1st time insertion success Feedback from clinicians about the process of developing this skill using ‘think-aloud’ method with a second clinician recording field notes.

Timepoint [8]

Pre-trial

Secondary outcome [9]

Clinical inserter’s reported ease of inserting, accessing (e.g. giving meds/flush), securing, dressing and/or overall care (0 = not easy to 10 very easy) (N=100 - 50 at each site).

Timepoint [9]

Six months after commencement of the study

Secondary outcome [10]

Policy drivers and decision makers’ views on the barriers and enablers of decisions about PIVC policy, and potential implementation of integrated system PIVCs: focus group/one-on-one interviews.

Timepoint [10]

Once the trial results are available

Secondary outcome [11]

Health related quality of life: EuroQol five dimensions questionnaire (EQ-5D) (minimum n=200; maximum 350)

Timepoint [11]

This instrument will be administered twice: (1) prior to the insertion of the PIVC (baseline), and (2) second daily visit (approx. 48hr +/- 12 hr) from enrollment.

Secondary outcome [12]

Patient satisfaction survey: Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General (FACIT-TS-G (50%) or AHPEQS (50%)) (minimum n=200; maximum 350)

Timepoint [12]

Second daily visit (approx. 48hr +/- 12 hr) from enrollment.

Eligibility

Key inclusion criteria

>18 years
PIVC to be inserted for clinical care for predicted >24 hours
Patient has given informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

PIVC placed under emergency conditions with inappropriate aseptic technique
Current bloodstream infection (positive blood culture within 48 hours)
Coexistent catheter (PIVC, intravenous midline, peripherally inserted central catheter or central venous catheter)
Language or cognitive barrier to consent
Previous enrolment in this study

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)

Central web-based service (Griffith University) with randomly varied block sizes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be cleaned and checked for missing and invalid values before importing into STATA. Descriptive characteristics and survey results will be presented using means and standard deviations (SDs) or medians and interquartile ranges (IQRs) for continuous variables and percentages for categorical variables. All randomised patients will be analysed by intention to treat with patients the unit of measurement and one PIVC per patient. Chi-squared or Fisher’s exact tests will be used to compare qualitative variables and the Student’s t test to compare quantitative variables. The primary analysis will compare the integrated and non-integrated groups. Baseline group comparisons will be by clinical parameters. Kaplan-Meier survival curves will be used to display the rate of events in relation to catheter-hours and catheter-days, with the log rank test used to compare differences in failure over time. Secondary endpoints will be compared between groups using parametric/nonparametric techniques. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure, and assess for an interaction effect. A per-protocol analysis will assess the effect of protocol violations. We will quantify additional costs, benefits, net monetary benefit, considering PIVCs indwelling time, reinsertions and treatment costs of complications/group. Cost-analyses using ANCOVA will be undertaken to compare group costs. P-values <0.05 will be statistically significant.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

24/07/2017

Actual

19/07/2017

Date of last participant enrolment

Anticipated

30/11/2019

Actual

17/12/2019

Date of last data collection

Anticipated

2/12/2019

Actual

21/12/2019

Sample size

Target

2200

Accrual to date

Final

1759

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Queen Elizabeth II Jubilee Hospital - Coopers Plains

Recruitment hospital [3]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4029 - Herston

Recruitment postcode(s) [2]

4108 - Coopers Plains

Recruitment postcode(s) [3]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Becton, Dickinson and Company

Address [1]

5859 Farinon Dr, San Antonio, TX 78249-3455, United States

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Rd, Nathan QLD 4111, Brisbane, Australia.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [1]

Level 0, Bray Centre (N54)
170 Kessels Rd, Nathan QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/12/2016

Approval date [1]

05/01/2017

Ethics approval number [1]

2017/002

Ethics committee name [2]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [2]

Level 7, Block 7
Royal Brisbane & Women's Hospital
Herston Qld 4029

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

04/11/2016

Approval date [2]

20/12/2016

Ethics approval number [2]

HREC/16/QRBW/527

Ethics committee name [3]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [3]

Level 3 Southern Research Facility (Perkins building)
11 Robin Warren Drive, Murdoch WA 6150

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

08/11/2016

Approval date [3]

06/12/2016

Ethics approval number [3]

Approved

Summary

Brief summary

Introduction:
Peripheral Venous Catheters (PVCs) are frequently used to provide treatment for hospitalised patients. However, the failure rate of these devices is extremely high. Recent evidence suggests that integrated PVC systems may improve patient outcomes compared to the traditional non-integrated PVC systems. However, more evidence is needed to inform clinical practice and guidelines.

Objectives:
1. To compare the clinical and cost-effectiveness of two PIVC systems: (i) integrated, and (ii) non-integrated (current practice) to prevent PIVC failure, insertion pain, microbial colonisation, functional dwell time, and adverse events.
2. To assess the acceptability and implementation challenges of integrated systems via quantitative and qualitative feedback from inserters, patients, clinicians and policy-makers.

Methods:
Two-arm randomised controlled trial including 2200 adult (greater than or equal to 18yrs) patients.
· Integrated system: BD Nexiva integrated intravenous catheter system with two SmartSite connectors to close the Y-connector completely (n=1100).
· Non-integrated system: B Braun Introcan Safety 3 or BD Insyte Autoguard catheter, Connecta extension set 15cm, with SmartSite connector/s (n=1100).

The primary outcome is PIVC failure: Composite endpoint of occlusion, infiltration, phlebitis/pain, dislodgement, haematoma, localised or bloodstream catheter-related infections.

Results:
Results could improve millions of patients' health outcomes by reducing PIVC complications and failure as well as clinicians' workloads and health-care costs.

Conclusion:
Results of this study could assist policy-maker decision-making about the best PIVC system choice, and inform clinical guidelines, which could benefit patients and health care systems worldwide.

Trial website

http://www.avatargroup.org.au/optimum.html

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Claire Rickard

Address

N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111

Country

Australia

Phone

+ 61 (07) 373 56460

Fax

[email protected]

Contact person for public queries

Name

Prof Claire Rickard

Address

N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111

Country

Australia

Phone

+61 (07) 373 56460

Fax

[email protected]

Contact person for scientific queries

Name

Prof Claire Rickard

Address

N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111

Country

Australia

Phone

+61 (07) 373 56460

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The current conditions set by the approving Human Research Ethics Committee/s do not provide approval for data sharing.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
826	Study protocol				https://bmjopen.bmj.com/content/8/5/e019916.info	372136-(Uploaded-18-12-2018-11-14-02)-Study-related document.pdf

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	Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): A randomised controlled trial protocol.	2018	https://dx.doi.org/10.1136/bmjopen-2017-019916
Embase	Health-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.	2024	https://dx.doi.org/10.1186/s12955-023-02217-8

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

Trial Review

Documents added manually

Documents added automatically