Standards for Reporting Qualitative Research (SRQR) checklist.

Standards for Reporting Qualitative Research (SRQR) checklist.</p

SANDWICH and usual care.

BackgroundProlonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process evaluation to understand how the intervention content and delivery was linked to trial outcomes.Methods10,495 children admitted to 18 paediatric intensive care units (ICUs) in the United Kingdom participated in a stepped-wedge, cluster randomised controlled trial, with 1955 clinical staff trained to deliver the intervention. The intervention comprised assessment and optimisation of sedation levels, and bedside screening of respiratory parameters to indicate readiness for a spontaneous breathing trial prior to liberation from ventilation. 193 clinical staff were interviewed towards the end of the trial. Interview data were thematically analysed, and quantitative adherence data were analysed using descriptive statistics.ResultsThe intervention led to a reduced duration of IMV (adjusted median difference– 7.1 hours, 95% CI -9.6 to -5.3, p = 0.01). Overall intervention adherence was 75% (range 59–85%). Ease and flexibility of the intervention promoted it use; designated responsibilities, explicit pathways of decision-making and a shared language for communication fostered proactivity and consistency towards extubation. Delivery of the intervention was hindered by established hospital and unit organisational and patient care routines, clinician preference and absence of clinical leadership.ConclusionsThe SANDWICH trial showed a significant, although small, reduction in duration of IMV. Findings suggest that greater direction in decision-making pathways, robust embedment of new practice in unit routine, and capitalising on the skills of Advanced Nurse Practitioners and physiotherapists would have contributed to greater intervention effect.Trial registrationisrctn.org Identifier: ISRCTN16998143.</div

SANDWICH logic model.

Adapted from Blackwood et al., 2022 [14]. COMFORT is the name of the tool used to assess sedation and comfort of infants and children in paediatric intensive care. Abbreviations: MDT, multidisciplinary team; PICU, paediatric intensive care unit; SBT, spontaneous breathing trial.</p

The proportion (%) of intervention adherence in each paediatric intensive care unit.

The proportion (%) of intervention adherence in each paediatric intensive care unit.</p

The SANDWICH trial schematic.

BackgroundProlonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process evaluation to understand how the intervention content and delivery was linked to trial outcomes.Methods10,495 children admitted to 18 paediatric intensive care units (ICUs) in the United Kingdom participated in a stepped-wedge, cluster randomised controlled trial, with 1955 clinical staff trained to deliver the intervention. The intervention comprised assessment and optimisation of sedation levels, and bedside screening of respiratory parameters to indicate readiness for a spontaneous breathing trial prior to liberation from ventilation. 193 clinical staff were interviewed towards the end of the trial. Interview data were thematically analysed, and quantitative adherence data were analysed using descriptive statistics.ResultsThe intervention led to a reduced duration of IMV (adjusted median difference– 7.1 hours, 95% CI -9.6 to -5.3, p = 0.01). Overall intervention adherence was 75% (range 59–85%). Ease and flexibility of the intervention promoted it use; designated responsibilities, explicit pathways of decision-making and a shared language for communication fostered proactivity and consistency towards extubation. Delivery of the intervention was hindered by established hospital and unit organisational and patient care routines, clinician preference and absence of clinical leadership.ConclusionsThe SANDWICH trial showed a significant, although small, reduction in duration of IMV. Findings suggest that greater direction in decision-making pathways, robust embedment of new practice in unit routine, and capitalising on the skills of Advanced Nurse Practitioners and physiotherapists would have contributed to greater intervention effect.Trial registrationisrctn.org Identifier: ISRCTN16998143.</div

Process of theme development (following Braun & Clarke, 2006).

Process of theme development (following Braun & Clarke, 2006).</p

<i>PLOS ONE</i> clinical studies checklist.

BackgroundProlonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process evaluation to understand how the intervention content and delivery was linked to trial outcomes.Methods10,495 children admitted to 18 paediatric intensive care units (ICUs) in the United Kingdom participated in a stepped-wedge, cluster randomised controlled trial, with 1955 clinical staff trained to deliver the intervention. The intervention comprised assessment and optimisation of sedation levels, and bedside screening of respiratory parameters to indicate readiness for a spontaneous breathing trial prior to liberation from ventilation. 193 clinical staff were interviewed towards the end of the trial. Interview data were thematically analysed, and quantitative adherence data were analysed using descriptive statistics.ResultsThe intervention led to a reduced duration of IMV (adjusted median difference– 7.1 hours, 95% CI -9.6 to -5.3, p = 0.01). Overall intervention adherence was 75% (range 59–85%). Ease and flexibility of the intervention promoted it use; designated responsibilities, explicit pathways of decision-making and a shared language for communication fostered proactivity and consistency towards extubation. Delivery of the intervention was hindered by established hospital and unit organisational and patient care routines, clinician preference and absence of clinical leadership.ConclusionsThe SANDWICH trial showed a significant, although small, reduction in duration of IMV. Findings suggest that greater direction in decision-making pathways, robust embedment of new practice in unit routine, and capitalising on the skills of Advanced Nurse Practitioners and physiotherapists would have contributed to greater intervention effect.Trial registrationisrctn.org Identifier: ISRCTN16998143.</div

SANDWICH implementation.

BackgroundProlonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process evaluation to understand how the intervention content and delivery was linked to trial outcomes.Methods10,495 children admitted to 18 paediatric intensive care units (ICUs) in the United Kingdom participated in a stepped-wedge, cluster randomised controlled trial, with 1955 clinical staff trained to deliver the intervention. The intervention comprised assessment and optimisation of sedation levels, and bedside screening of respiratory parameters to indicate readiness for a spontaneous breathing trial prior to liberation from ventilation. 193 clinical staff were interviewed towards the end of the trial. Interview data were thematically analysed, and quantitative adherence data were analysed using descriptive statistics.ResultsThe intervention led to a reduced duration of IMV (adjusted median difference– 7.1 hours, 95% CI -9.6 to -5.3, p = 0.01). Overall intervention adherence was 75% (range 59–85%). Ease and flexibility of the intervention promoted it use; designated responsibilities, explicit pathways of decision-making and a shared language for communication fostered proactivity and consistency towards extubation. Delivery of the intervention was hindered by established hospital and unit organisational and patient care routines, clinician preference and absence of clinical leadership.ConclusionsThe SANDWICH trial showed a significant, although small, reduction in duration of IMV. Findings suggest that greater direction in decision-making pathways, robust embedment of new practice in unit routine, and capitalising on the skills of Advanced Nurse Practitioners and physiotherapists would have contributed to greater intervention effect.Trial registrationisrctn.org Identifier: ISRCTN16998143.</div

Supporting quotes.

BackgroundProlonged mechanical ventilation increases the risk of mortality and morbidity. Optimising sedation and early testing for possible liberation from invasive mechanical ventilation (IMV) has been shown to reduce time on the ventilator. Alongside a multicentre trial of sedation and ventilation weaning, we conducted a mixed method process evaluation to understand how the intervention content and delivery was linked to trial outcomes.Methods10,495 children admitted to 18 paediatric intensive care units (ICUs) in the United Kingdom participated in a stepped-wedge, cluster randomised controlled trial, with 1955 clinical staff trained to deliver the intervention. The intervention comprised assessment and optimisation of sedation levels, and bedside screening of respiratory parameters to indicate readiness for a spontaneous breathing trial prior to liberation from ventilation. 193 clinical staff were interviewed towards the end of the trial. Interview data were thematically analysed, and quantitative adherence data were analysed using descriptive statistics.ResultsThe intervention led to a reduced duration of IMV (adjusted median difference– 7.1 hours, 95% CI -9.6 to -5.3, p = 0.01). Overall intervention adherence was 75% (range 59–85%). Ease and flexibility of the intervention promoted it use; designated responsibilities, explicit pathways of decision-making and a shared language for communication fostered proactivity and consistency towards extubation. Delivery of the intervention was hindered by established hospital and unit organisational and patient care routines, clinician preference and absence of clinical leadership.ConclusionsThe SANDWICH trial showed a significant, although small, reduction in duration of IMV. Findings suggest that greater direction in decision-making pathways, robust embedment of new practice in unit routine, and capitalising on the skills of Advanced Nurse Practitioners and physiotherapists would have contributed to greater intervention effect.Trial registrationisrctn.org Identifier: ISRCTN16998143.</div

Development, implementation and evaluation of an evidence-based paediatric early warning system improvement programme: the PUMA mixed methods study

BackgroundPaediatric mortality rates in the United Kingdom are amongst the highest in Europe. Clinically missed deterioration is a contributory factor. Evidence to support any single intervention to address this problem is limited, but a cumulative body of research highlights the need for a systems approach. MethodsAn evidence-based, theoretically informed, paediatric early warning system improvement programme (PUMA Programme) was developed and implemented in two general hospitals (no onsite Paediatric Intensive Care Unit) and two tertiary hospitals (with onsite Paediatric Intensive Care Unit) in the United Kingdom. Designed to harness local expertise to implement contextually appropriate improvement initiatives, the PUMA Programme includes a propositional model of a paediatric early warning system, system assessment tools, guidance to support improvement initiatives and structured facilitation and support. Each hospital was evaluated using interrupted time series and qualitative case studies. The primary quantitative outcome was a composite metric (adverse events), representing the number of children monthly that experienced one of the following: mortality, cardiac arrest, respiratory arrest, unplanned admission to Paediatric Intensive Care Unit, or unplanned admission to Higher Dependency Unit. System changes were assessed qualitatively through observations of clinical practice and interviews with staff and parents. A qualitative evaluation of implementation processes was undertaken. ResultsAll sites assessed their paediatric early warning systems and identified areas for improvement. All made contextually appropriate system changes, despite implementation challenges. There was a decline in the adverse event rate trend in three sites; in one site where system wide changes were organisationally supported, the decline was significant (ß = -0.09 (95% CI: − 0.15, − 0.05); p = ConclusionsSystem level change to improve paediatric early warning systems can bring about positive impacts on clinical outcomes, but in paediatric practice, where the patient population is smaller and clinical outcomes event rates are low, alternative outcome measures are required to support research and quality improvement beyond large specialist centres, and methodological work on rare events is indicated. With investment in the development of alternative outcome measures and methodologies, programmes like PUMA could improve mortality and morbidity in paediatrics and other patient populations.</div