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

Maria Isabel Castillo; Emily Larsen; Marie Cooke; Nicole M Marsh; Marianne C Wallis; Julie Finucane; Peter Brown; Gabor Mihala; Peter J Carr; Joshua Byrnes; Rachel Walker; Prudence Cable; Li Zhang; Candi Sear; Gavin Jackson; Anna Rowsome; Alison Ryan; Julie C Humphries; Susan Sivyer; Kathy Flanigan; Claire M Rickard

doi:10.1136/bmjopen-2017-019916

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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

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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

Maria Isabel Castillo, Emily Larsen, Marie Cooke, Nicole M Marsh, Marianne C Wallis, Julie Finucane, Peter Brown, Gabor Mihala, Peter J Carr, Joshua Byrnes, …

BMJ Open, Vol.8(5), pp.e019916-e019916

05/2018

DOI: https://doi.org/10.1136/bmjopen-2017-019916

PMCID: PMC5961612

PMID: 29764876

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Abstract

IntroductionPeripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost–utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system.Methods and analysisTwo-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. Secondary outcomes: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost–utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques.Ethics and disseminationEthical approval from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/16/QRBW/527), Griffith University Human Research Ethics Committee (Ref No. 2017/002) and the South Metropolitan Health Services Human Research Ethics Committee (Ref No. 2016–239). Results will be published in peer-reviewed journals.Trial registration numberACTRN12617000089336.

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Title: 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
Creators: Maria Isabel Castillo - Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Emily Larsen - Nursing and Midwifery Research Centre, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
Marie Cooke - Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Nicole M Marsh - Nursing and Midwifery Research Centre, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
Marianne C Wallis - School of Nursing, Midwifery and Paramedicine, University of Sunshine Coast, Sunshine Coast, Queensland, Australia
Julie Finucane - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Peter Brown - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Gabor Mihala - Centre for Applied Health Economics, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Peter J Carr - Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Joshua Byrnes - Centre for Applied Health Economics, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Rachel Walker - Princess Alexandra Hospital, Brisbane, Queensland, Australia
Prudence Cable - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Li Zhang - Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
Candi Sear - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Gavin Jackson - Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Anna Rowsome - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Alison Ryan - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Julie C Humphries - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Susan Sivyer - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Kathy Flanigan - Queen Elizabeth II Jubilee Hospital, Brisbane, Queensland, Australia
Claire M Rickard - Princess Alexandra Hospital, Brisbane, Queensland, Australia
Publication Details: BMJ Open, Vol.8(5), pp.e019916-e019916
Publisher: B M J Group
Identifiers: 991012926995202368
Copyright: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by nc/4.0/ © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Academic Unit: Faculty of Health; Nursing
Language: English
Resource Type: Journal article

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

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