Preventing adverse events during paediatric cancer treatment: protocol for a multi-site hybrid randomised controlled trial of catheter lock solutions (the CLOCK trial).

INTRODUCTION: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock. METHODS AND ANALYSIS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers. ETHICS AND DISSEMINATION: Ethics approval has been provided by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000499785.

Implementation frameworks, strategies and outcomes in optimizing central venous access device practice in paediatrics: A scoping review.

Paediatric patients with complex or acute conditions may require a central venous access device, however, almost one-third of these devices have associated complications (e.g. infections). Implementation of evidence-based practices regarding central venous access devices can reduce and potentially prevent complications. AIMS: This scoping review aimed to explore recent interventional research in CVAD management through an implementation lens. DESIGN: This scoping review used the Arksey and O'Malley framework. Studies were included if they were written in English, published in 2012 to July 2023, involved children and were relevant to the study aims. Risk of bias was appraised by the Mixed Methods Appraisal Tool. DATA SOURCES: Searches were undertaken in EMBASE, CINAHL (Ebsco), PubMed, Web of Science and Cochrane Library (CENTRAL). RESULTS: Of the 1769 studies identified in a systematic search, 46 studies were included. Studies mostly focused on health professionals and central venous access device maintenance and had quantitative pre-post study designs. Adherence to implementation frameworks was lacking, with many studies employing quality improvement approaches. Implementation strategies were typically multipronged, using health-professional education, bundles and working groups. Bundle compliance and reductions in central line-associated bloodstream infections were the most featured outcomes, with most studies primarily focusing on effectiveness outcomes. CONCLUSION: Translation of evidence-based practices to the clinical setting is difficult and current adoption of implementation frameworks (apart from 'quality improvement') is limited. Implementation strategies are diverse and dependent on the local context, and study outcomes typically focus on the effectiveness of the physical intervention, rather than measuring the implementation effort itself. IMPLICATIONS FOR PATIENTS: Future intervention research requires a more uniform and deliberate application of implementation frameworks and strategies. IMPACT: Greater exploration of relationships between frameworks and strategies and implementation and service outcomes is required to increase understanding of their role in maximizing resources to improve health care. Adhered to best reporting guidelines as per PRISMA-ScR (Tricco et al., 2018). PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.