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      The ACCELERATE Plus (assessment and communication excellence for safe patient outcomes) Trial Protocol: a stepped-wedge cluster randomised trial, cost-benefit analysis, and process evaluation

      research-article
      1 , 2 , 1 , 3 , 3 , 4 , 4 , 1 , 2 , 5 , 6 , 1 , 3 , 3 , 1 , 7 , 1 , 7 , 8 , 9 , 7 , 9 , 10 , 11 , 9 , 12 , 12 , 10 , 12 , 13 , 14 , 15 , 10 , 16 , 12 , 10 , 7 , 17 , 13 , 12 , 18 , 19 , 3 , 20 , 1 , 2 , 1 , 2 , , on behalf of the ACCELERATE Plus Project Team
      BMC Nursing
      BioMed Central
      Evidence-based nursing, Implementation science, Patient safety, Nursing assessment, Clinical handover, Multidisciplinary handover communication, Randomised controlled trial, Cost–benefit analysis, Process evaluation, Learning health system.

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          Abstract

          Background

          Nurses play an essential role in patient safety. Inadequate nursing physical assessment and communication in handover practices are associated with increased patient deterioration, falls and pressure injuries. Despite internationally implemented rapid response systems, falls and pressure injury reduction strategies, and recommendations to conduct clinical handovers at patients’ bedside, adverse events persist. This trial aims to evaluate the effectiveness, implementation, and cost–benefit of an externally facilitated, nurse-led intervention delivered at the ward level for core physical assessment, structured patient-centred bedside handover and improved multidisciplinary communication. We hypothesise the trial will reduce medical emergency team calls, unplanned intensive care unit admissions, falls and pressure injuries.

          Methods

          A stepped-wedge cluster randomised trial will be conducted over 52 weeks. The intervention consists of a nursing core physical assessment, structured patient-centred bedside handover and improved multidisciplinary communication and will be implemented in 24 wards across eight hospitals. The intervention will use theoretically informed implementation strategies for changing clinician behaviour, consisting of: nursing executive site engagement; a train-the-trainer model for cascading facilitation; embedded site leads; nursing unit manager leadership training; nursing and medical ward-level clinical champions; ward nurses’ education workshops; intervention tailoring; and reminders. The primary outcome will be a composite measure of medical emergency team calls (rapid response calls and ‘Code Blue’ calls), unplanned intensive care unit admissions, in-hospital falls and hospital-acquired pressure injuries; these measures individually will also form secondary outcomes. Other secondary outcomes are: i) patient-reported experience measures of receiving safe and patient-centred care, ii) nurses’ perceptions of barriers to physical assessment, readiness to change, and staff engagement, and iii) nurses’ and medical officers’ perceptions of safety culture and interprofessional collaboration. Primary outcome data will be collected for the trial duration, and secondary outcome surveys will be collected prior to each step and at trial conclusion. A cost–benefit analysis and post-trial process evaluation will also be undertaken.

          Discussion

          If effective, this intervention has the potential to improve nursing care, reduce patient harm and improve patient outcomes. The evidence-based implementation strategy has been designed to be embedded within existing hospital workforces; if cost-effective, it will be readily translatable to other hospitals nationally.

          Trial registration

          Australian New Zealand Clinical Trials Registry ID: ACTRN12622000155796. Date registered: 31/01/2022.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12912-023-01439-x.

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          Most cited references50

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          Fitting Linear Mixed-Effects Models Usinglme4

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            The behaviour change wheel: A new method for characterising and designing behaviour change interventions

            Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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              Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

              Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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                Author and article information

                Contributors
                sandy.middleton@acu.edu.au
                Journal
                BMC Nurs
                BMC Nurs
                BMC Nursing
                BioMed Central (London )
                1472-6955
                21 August 2023
                21 August 2023
                2023
                : 22
                : 275
                Affiliations
                [1 ]GRID grid.411958.0, ISNI 0000 0001 2194 1270, Nursing Research Institute, St Vincent’s Health Network Sydney, St Vincent’s Hospital Melbourne, Australian Catholic University, ; De Lacy Building, 390 Victoria Street, Darlinghurst, NSW 2010 Australia
                [2 ]GRID grid.411958.0, ISNI 0000 0001 2194 1270, School of Nursing, Midwifery and Paramedicine, , Australian Catholic University, ; 40 Edward Street, North Sydney, NSW 2060 Australia
                [3 ]St Vincent’s Health Network Sydney, 390 Victoria Street, Darlinghurst, NSW 2010 Australia
                [4 ]GRID grid.1001.0, ISNI 0000 0001 2180 7477, Institute for Communication in Healthcare, Australian National University, ; Baldessin Precinct Building, 110 Ellery Crescent, Acton, ACT 2601 Australia
                [5 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, School of Public Health, , University of Sydney, ; Edward Ford Building, A27 Fisher Road, Camperdown, NSW 2006 Australia
                [6 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, ; Medical Foundation Building, 92-94 Parramatta Road, Camperdown, NSW 2050 Australia
                [7 ]GRID grid.413105.2, ISNI 0000 0000 8606 2560, St Vincent’s Hospital Melbourne, ; 41 Victoria Parade, Fitzroy, VIC 3065 Australia
                [8 ]GRID grid.1031.3, ISNI 0000000121532610, Southern Cross University, ; Military Road, East Lismore, NSW 2480 Australia
                [9 ]Northern NSW Local Health District, Crawford House, Hunter Street, Lismore, NSW 2480 Australia
                [10 ]GRID grid.410692.8, ISNI 0000 0001 2105 7653, South Western Sydney Local Health District, Liverpool Hospital Eastern Campus, ; Corner of Lachlan and Hart Streets, Liverpool, NSW 2170 Australia
                [11 ]GRID grid.429098.e, Ingham Institute for Applied Medical Research, ; 1 Campbell Street, Liverpool, NSW 2170 Australia
                [12 ]GRID grid.1007.6, ISNI 0000 0004 0486 528X, University of Wollongong, ; Northfields Avenue, Wollongong, NSW 2522 Australia
                [13 ]GRID grid.460750.0, ISNI 0000 0004 0640 1622, Lismore Base Hospital, ; 60 Uralba Street, Lismore, NSW 2480 Australia
                [14 ]GRID grid.477714.6, ISNI 0000 0004 0587 919X, South Eastern Sydney Local Health District, The Sutherland Hospital and Community Health Service, ; Corner The Kingsway and Kareena Road, Caringbah, NSW 2229 Australia
                [15 ]GRID grid.482212.f, ISNI 0000 0004 0495 2383, Sydney Local Health District, ; King George V Building, Missenden Road, Camperdown, NSW 2050 Australia
                [16 ]GRID grid.432149.9, ISNI 0000 0004 0577 5905, Fairfield Hospital, ; Polding Street and Prairie Vale Road, Prairiewood, NSW 2176 Australia
                [17 ]GRID grid.460648.8, ISNI 0000 0004 0626 0356, The Sutherland Hospital, ; Corner The Kingsway and Kareena Road, Caringbah, NSW 2229 Australia
                [18 ]GRID grid.413249.9, ISNI 0000 0004 0385 0051, Royal Prince Alfred Hospital, ; 50 Missenden Road, Camperdown, NSW 2050 Australia
                [19 ]GRID grid.416398.1, ISNI 0000 0004 0417 5393, St George Hospital, ; Gray Street, Kogarah, NSW 2217 Australia
                [20 ]GRID grid.415193.b, Prince of Wales Hospital, ; 320-346 Barker Street, Randwick, NSW 2031 Australia
                Article
                1439
                10.1186/s12912-023-01439-x
                10440862
                37605224
                e848ac7d-6b6c-4b73-a81d-8a2fa893ddae
                © BioMed Central Ltd., part of Springer Nature 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 8 June 2023
                : 8 August 2023
                Funding
                Funded by: Maridulu Budyari Gumal Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
                Award ID: Big Ideas Grant
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                Award Recipient :
                Funded by: New South Wales Nursing and Midwifery Strategy Reserve Fund
                Funded by: National Health and Medical Research Council Investigator Leadership Grant
                Award ID: 1196352
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2023

                Nursing
                evidence-based nursing,implementation science,patient safety,nursing assessment,clinical handover,multidisciplinary handover communication,randomised controlled trial,cost–benefit analysis,process evaluation,learning health system.

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