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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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    Castillo EscobarPUB6132.pdf (223.4Kb)
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    Author(s)
    Castillo, Maria Isabel
    Larsen, Emily
    Cooke, Marie
    Marsh, Nicole M
    Wallis, Marianne C
    Finucane, Julie
    Brown, Peter
    Mihala, Gabor
    Carr, Peter J
    Byrnes, Joshua
    Walker, Rachel
    Cable, Prudence
    Zhang, Li
    Sear, Candi
    Jackson, Gavin
    Rowsome, Anna
    Ryan, Alison
    Humphries, Julie C
    Sivyer, Susan
    Flanigan, Kathy
    Rickard, Claire M
    Griffith University Author(s)
    Walker, Rachel M.
    Cooke, Marie L.
    Byrnes, Joshua M.
    Larsen, Emily N.
    Year published
    2018
    Metadata
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    Abstract
    Introduction Peripheral 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 ...
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    Introduction Peripheral 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 analysis Two-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.
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    Journal Title
    BMJ Open
    Volume
    8
    Issue
    5
    DOI
    https://doi.org/10.1136/bmjopen-2017-019916
    Copyright Statement
    © The Author(s) 2018. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
    Subject
    Health economics
    Medical devices
    Nursing
    Publication URI
    http://hdl.handle.net/10072/382061
    Collection
    • Journal articles

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