Individual Paediatric Early Warning System (I-PEWS) – Does systematic incorporation of nurses clinical judgment in a Paediatric Early Warning System improve detection of clinical deterioration in hospitalised paediatric patients 

The overall aim is this project is to improve the performance of PEWS and its acceptability among healthcare professionals. The study aims to evaluate a new I-PEWS which involves nurses’ clinical assessment on the number of patients experiencing unplanned transfers to a higher level of care. 

Study I
Study I is a scoping review aiming at identifying the signs and symptoms that trigger nurses’ worry or concern about a paediatric patient’s condition.

Study II Study II aims at identifying and describing the expected pathological picture for hospitalized paediatric patients with high PEWS score  that do not raise concern for the hospital  staff in a Delphi Study.

Study III
Study III aims at investigating if a new I-PEWS incorporating the results from study I and II will  improve the performance in detecting children at risk of clinical deterioration in a prospective cluster randomised, cross-over project.

Study I
The systematic scoping review of quantitative and qualitative studies will be performed using the Joanna Briggs Institute (JBI) methodology for Scoping Reviews 2015 guidelines as guidance to structure the review process. In accordance with the JBI approach , a three-step search strategy will be utilized.

Study II
A modified Delphi process will be used.  After each round, the statements that achieve consensus will be eliminated, and statements that do  not achieve consensus will  carry through to the next round of questioning.  This approach will be taken to maximise participation in the study through minimising responder fatigue.

Study III
This study will be designed as a prospective cluster randomised, cross-over, superiority study.
The project is integrated into the daily workflow, where patients are automatically included when admitted to a participating department. Before the start of the project, each department is randomized to 6½ months with either the current PEWS scoring system or the new I-PEWS scoring system with incorporated clinical assessment. Computer generated numbers will be used for randomization, after which the respective management will be briefed. A crossover takes place at each department, so the project will run 13 months.
The rationale behind the cluster design is that a study such as this is not practically possible at an individual level, where intervention is done on a workflow performed several times daily and by shifting staff.     

Cluster criteria
The following criteria must be meet for a department can be defined as a cluster:

• Systematic use of PEWS
• Admission of acute patients
• Intensive care unit available

Inclusion criteria
All patients (0-19 years) admitted at the participating departments (>24 hours).

Exclusion criteria
Exclusion criteria are: (i) children admitted directly to neonatal wards, (ii) children admitted directly to PICUs, (iii) children who were dead upon arrival at the hospitals, (iv) children admitted because of social interaction problems and (v) children receiving palliative care.

The I-PEWS will continue to apply systematic observation, where patients are evaluated according to basic vital parameters generating a PEWS score of 0-24, as done in the current PEWS. In the new I-PEWS, the nurse can maximize the score by 6 points or maximally downgrade with 4 points. This assessment is based on clinical experience, nursing worry indicators (identified in the scoping review), classical, expected pathological picture for patients in the department, the current clinical picture of the patient, knowledge of the individual patient and the patient's and the relatives' concern and assessment of the condition. The aggregated score continues to interact with the already existing action algorithm. Thus, relevant actions and observation frequency are still ensured, but this is based on an I-PEWS based on the systematic measurement of vital parameters in conjunction with a systematic nursing clinical assessment of the patient.

Primary outcome
The primary outcome is the number of patients experiencing in-hospital clinical deterioration requiring transfer to a higher level of care. Unplanned transfers are defined as transfers that were not elective or planned in advance, or transfers directly from the operating room.

Secondary outcomes
The secondary outcomes are (i) pediatric index of mortality score 3 (PIM3), (ii) severity of illness during the PICU stay based on invasive ventilation and inotropes, Continuous Positive Airway Pressure (CPAP) and Extra Corporal Membran Oxygenation (ECMO); iii) length of hospital stay, iv) length of PICU stay, v)Average PEWS score, number of PEWS scores, number of changes in PEWS scores, vi) Adherence to PEWS re-scoring times. 

The project is closely rooted in clinical practice as PEWS has been introduced as a standard since 2014. However, research have shown that improvement is needed to ensure maximum safety in the ongoing observation and risk assessment of paediatric patients. This project aims to optimize a clinical tool that is used many times daily in all departments nationally and is therefore considered to have major socially relevance, closely related to clinical practice at the included hospitals and of future importance for the other Danish hospitals. The introduction of clinical assessment in I-PEWS is expected to make greater commitment to the use of PEWS among staff. The project will continue the research with the newest evidence available from a PhD project conducted in the Central Denmark Region, which has identified limitations of the current PEWS.
The project will contribute to the existing knowledge of changes in physiological parameters and nurses’ clinical judgment in relation to clinical deterioration of paediatric patients as well as to enhance the evidence for the use of PEWS. Hopefully, providing knowledge that can help improve treatment and safety for all hospitalised paediatric.