Title: PUMA - Paediatric early warning system (PEWS): Utilisation and Mortality Avoidance. A prospective, mixed methods, before and after study identifying the evidence base for the core components of an effective PEWS and the development of an implementation package for implementation and use in the UK
Funder: Health and Care Research Wales (Welsh Government)

Abstract: UK paediatric mortality is the highest in Europe(4000/yr) (1). There is evidence suggesting that missed deterioration (2,3) and difference in hospital performance contribute (4). Mandatory Child Death Overview Panels review all paediatric deaths in England to identify preventable factors, but recommendations are largely public health focused. The narrative nature of the hospital data collected limits identification of preventable factors. Feedback loops are required to ensure organisational accountability and compliance with initiatives to improve patient safety and reduce harm. Research in adult care identified that acute in-hospital deterioration is often preceded by a period of physiological instability which, when recognised, provides an opportunity for earlier intervention to improve outcome (5,6). The Royal College of Physicians endorsed the implementation of a National Early Warning system(7) to standardise the assessment of acute illness severity, predicting that 6000 lives will be saved annually. A similar intervention may save lives in hospitalised children (8,9,10) but the evidence base for a national Paediatric Early Warning System is uncertain. Definitions 1) A track and trigger tool (11) is derived from physiological, clinical and observational data recorded by staff. This can include data such as respiratory rate, oxygen requirement, peripheral oxygen saturation, effort of breathing, heart rate, systolic/diastolic blood pressure, capillary refill time and a basic neurology assessment. Each component contributes to the calculation of a score which directs staff to undertake certain actions; including, but not limited to, altered frequency of observation, senior nurse or urgent medical review. 2) A Paediatric Early Waring System (PEWS) describes a multi-faceted organisational process imbedded in paediatric wards which may or may not involve a track and trigger score. Track and trigger tools have developed in the UK in an ad hoc way, many based on consensus opinion, with limited evidence base or evaluation of effectiveness (12). There are several reasons for this: a) Evaluation requires significant resource. Currently hospitals use paper based systems to record paediatric physiological signs and clinical assessment, to judge whether a patient is seriously ill or deteriorating. b) There is significant heterogeneity in the track and trigger tools used (12). There is no consensus of the data points which should be collected or the thresholds where clinicians should be concerned. c) Physiological alteration in respiratory and heart rate from birth to adulthood, make it impossible to develop a single standardised score suitable for all sick children. This combination of factors limits the ability to compare the performance of PEW scores. d) Single studies [13,14,15] have been underpowered for the outcomes they studied, for example rates for in-hospital respiratory or cardiac arrest is low (0.19 to 2.45 /1000 admissions) (9). e) Compliance with the monitoring required to calculate track and trigger scores and escalation of concern is varied , which impacts on the ability to demonstrate effectiveness of the intervention. f) This is a complex intervention which involves the use a tool, underpinned by an organisational safety system/culture to identify and respond to patients flagged as at risk of deterioration. That preparedness includes staff training, human resource, senior supervision and effective communication, which impact on patient outcome. There is 85% track and trigger score utilisation in England and Wales [12]. The current ad hoc utilisation of un-validated track and trigger tools and variance in organisational capacity to respond to deterioration represents a serious clinical risk. Research Questions: What is the evidence for the core components of a national paediatric track and trigger tool? What is the evidence that the implementation of paediatric track and trigger tool in the UK NHS environment will reduce avoidable morbidity and mortality in hospitalised children? What are the (micro, meso and macro) contextual features consequential for its success? What factors are necessary to support successful implementation and normalisation? Study Aims and Objectives: Identify through a systematic review of the literature the evidence for the core components of a paediatric track and trigger tool Develop theories about the mechanisms by which they have their effects Develop a track and trigger tool for use in different contexts Develop an implementation package for prospective evaluation Evaluate the ability of the track and trigger tool to impact on clinical outcomes Identify the contextual factors that are consequential for tool effectiveness Develop evidence-based recommendations for a national PEWS with underpinning programme theories. Identify the key ingredients of successful implementation and normalisation Study design: Work stream 1: Systematic review of the evidence and tool development: The development of a track and trigger tool and an implementation manual based on systematic review and expert consultation. Work steam 2: A prospective mixed method, before-and-after study design in four hospitals, with embedded case studies is proposed. These embedded case studies within the study at each phase will evaluate normal practice, the process of implementation and the use of the track and trigger tool post implementation. 1) Observe outcomes in current practice 2) Implement the system 3) Evaluate the system in use The effectiveness of the implemented system will be assessed by examining the change in the core outcomes using an interrupted time series sampling and analysis method. The quantitative outcomes will be mortality and cardiac and respiratory arrest, unplanned admission to Paediatric Intensive Care (PICU) or Paediatric High Dependency Unit (PHDU), medical emergencies requiring immediate assistance, referrals for PICU review (in tertiary centres) or PICU retrieval (DGHs) and the Critical Deterioration (CD) metric (a composite measure of critical events) (16). Qualitatively, realistic evaluation will be used to assess the mechanisms by which the PEWS has its effects and the factors necessary to successful implementation and normalisation

Lay abstract: In 2011 a research study [1] compared the child health outcomes and death rate in the UK with other European countries. It was worrying that UK measures of child health were amongst the worst in Europe. It is not clear why that is and further work needs to be done to understand this better. In hospital staff try to quickly identify the children who are seriously ill or getting sicker, so that they receive rapid treatment to improve their condition. Despite training, sometimes children become sicker in hospital without staff noticing or they underestimate the severity of illness, or do not treat deterioration quickly enough, or get extra help. In these cases the very sick child might require emergency transfer to intensive care, or stop breathing, or die unexpectedly. This study aims to develop and understanding of a number of key pieces of information that could help to standardise monitoring of children in hospital, help to identify deterioration quickly so there is an urgent response to save the patient from harm and reduce premature death in hospitalised children across the United Kingdom. This research study will be completed over 4 years in four hospitals and aims to examine what key components should be included in a track and trigger score and early warning system, to help identify the children who are sicker and prevent them becoming more unwell, having a serious complication or dying. We will be able to make recommendations about safety processes that should be established in every hospital treating paediatric in-patients across the NHS. Research Questions: a) What are the core components for an evidence based national Paediatric Early Warning System (PEWS)? b) What is the evidence that the implementation of PEWS in the UK NHS environment will reduce avoidable morbidity and mortality in hospitalised children? c) How does it work in real life and what processes and systems need to be in place for success? d) What factors are necessary to support successful implementation and continued use? Using two work streams, we will be focusing on: 1) The development of a track and trigger tool and an implementation package and manual for use in hospitals, based on the best research evidence available. This will help hospital staff identify the sicker children at risk of deterioration. Using a systematic review we will examine the published evidence concerning the most effective and validated track and trigger tool and the processes and support needed around the use of the tool. We will make recommendations based on the best research about the organisation of hospital resources so that seriously ill or deteriorating children get the most appropriate help. The systematic review will also inform the development of an implementation package and manual for use in implementation of the system and the second work stream. 2) We will look at existing practice in two big specialist children’s hospitals, and in two district general hospitals with paediatric wards. There will be three parts to this a) We will try to understand the size of the problem of deterioration of unwell children in these hospitals and what opportunities exist to prevent deterioration. a) We will then introduce the PEWS based on the best research available identified in the first work stream, and provide training to the staff about the new system and how it should work. c) We will then evaluate whether the staff use the system as it was intended, and look at whether this makes a difference in preventing children getting seriously ill or dying. This is essentially a before and after study design. We will assess the effectiveness of the new tool in two ways firstly by collecting data on core outcomes over the study period such as death, cardiac and respiratory arrest, unplanned admissions to intensive care and by sampling intermittently over the study duration we will examine the change in these outcomes. Secondly we will also examine the processes of tool use, by case studies to make sure we understand how the track and trigger tool is effective in predicting deterioration and triggering timely interventions, identify the contextual features consequential for success and factors necessary to ensure successful implementation. This research team consists of a mix of experienced clinical researchers, a social scientist, statisticians, doctors and nurses with expertise in working to improve detection of sick or deteriorating children in hospital. Parents have been involved in the design of the study, and in the development of information, so that their opinions are captured. All the work will be analysed so that recommendations can be made which apply to all hospitals treating children. The team will: • Work with major organisations like the Royal College of Nursing, NHS England, NHS Wales, Action for Sick Children and the Royal College of Paediatrics and Child Health from the start of the project, to get their support throughout the project so they will endorse the study recommendations. • Develop information for parents encouraging them to speak up if they're worried that their child getting sicker in hospital. • Define the training required for clinical staff so that they get experienced at looking for deterioration and know exactly what to do if a patient is getting sicker. • Publish the research findings in journals (magazines) aimed at doctors and nurses who look after children in hospital, so that their knowledge can be improved. • Present the research at conferences in the UK and internationally, so that managers and senior clinicians can influence change at their hospitals. There is, as yet, no consensus on the utility of the currently available track and trigger tools and systems and there is variance in monitoring of patients (17), training to aid recognition and response to deterioration. Patients admitted to hospital, and their families should have the expectation of excellent care. Therefore research that aims to reduce missed deterioration and prevent avoidable mortality, as well as limiting un-necessary NHS added cost and litigation (from failure to rescue), is both relevant and timely. There is an urgent national need to develop an evidence based track and trigger tool system for UK practice. This will be the largest, most comprehensive study of PEW scores and systems, with the aim to improve paediatric patient safety and reduce mortality.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE