TY - JOUR
T1 - Improving difficult peripheral intravenous access requires thought, training and technology (DART3): a stepped-wedge, cluster randomised controlled trial protocol
AU - Schults, Jessica A.
AU - Marsh, Nicole
AU - Ullman, Amanda J.
AU - Kleidon, Tricia M.
AU - Ware, Robert S.
AU - Byrnes, Joshua
AU - Young, Emily
AU - Hall, Lisa
AU - Keijzers, Gerben
AU - Cullen, Louise
AU - Calleja, Pauline
AU - McTaggart, Steven
AU - Peters, Nathan
AU - Watkins, Stuart
AU - Corley, Amanda
AU - Brown, Christine
AU - Lin, Zhen
AU - Williamson, Frances
AU - Burgess, Luke
AU - Macfarlane, Fiona
AU - Cooke, Marie
AU - Battley, Callan
AU - Rickard, Claire M.
N1 - Funding Information:
We acknowledge and thank the following persons for their assistance in developing and implementing this study: Dr Rebecca Paterson Ms Daner Ball and Mr Eugene Slaughter for research assistance, Dr Krispin Hajkowicz, Dr Henry Goldstein for assistance obtaining grant funds. Dr Stephanie Hadikusumo, Andy Carter, and Alice Bhasale for assistance obtaining grant funds and/or trial operationalisation. Hannah Peach, Jonathan Vico Da Silva, Bridget Wilson, Aoife Reynolds, Alison Craswell and Paula Cattanach for trial operationalisation.
Publisher Copyright:
© 2023, Crown.
PY - 2023/6/7
Y1 - 2023/6/7
N2 - Background: Peripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities. Methods: A stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie’s Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention. Discussion: Study findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities. Trial registration: Prospectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897).
AB - Background: Peripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities. Methods: A stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie’s Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention. Discussion: Study findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities. Trial registration: Prospectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897).
UR - http://www.scopus.com/inward/record.url?scp=85161081416&partnerID=8YFLogxK
U2 - 10.1186/s12913-023-09499-0
DO - 10.1186/s12913-023-09499-0
M3 - Article
C2 - 37286977
AN - SCOPUS:85161081416
SN - 1472-6963
VL - 23
SP - 1
EP - 12
JO - BMC Health Services Research
JF - BMC Health Services Research
IS - 1
M1 - 587
ER -