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Table 3 EPOCH secondary outcomes

From: Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial

Clinical

 

(1) Significant clinical deterioration event

See Table 4

(2) The nature of clinical deterioration events

Clinical deterioration events will be described by using the Children’s Resuscitation Intensity Scale (Table 4). Urgent PICU admissions that are initiated when the patient is in the operating room will not be regarded as clinical deterioration events

(3) Potentially preventable cardiac arrest

Assessment of the potential preventability of cardiac arrest will be determined for all patients who had a cardiac arrest event while in an eligible inpatient ward, without a preceding DNR order (Table 5)

Thus, potential preventability ratings of 4: ‘more than likely (more than 50/50, but “close call”);’ 5: ‘strong evidence of preventability;’ 6: ‘virtually certain evidence of preventability’ will be deemed potentially preventable cardiac arrest events

Preventability will be rated by blinded reviewers reviewing anonymized and delinked clinical data presented in a standardized format. If consensus between the two initial reviewers still cannot be reached then the opinion of the third reviewer will be used as the consensus rating

(4) Unplanned re-admission to the hospital within 48 h of hospital discharge

This outcome will be operationalized as re-admission before midnight of the second day full day after discharge. Thus, re-admission will occur before the 3rd midnight following hospital discharge

(5) Unplanned PICU readmission within 2 days of PICU discharge

This outcome will be operationalized as re-admission before midnight of the second full day after discharge. Thus, re-admission will occur before the 3rd midnight following PICU discharge

(6) PIM score predicted the risk of mortality

 

(7) PICU mortality.

 

(8) The PELOD score for PICU stay and the first 24 h in PICU

This score will be determined for both the entire PICU stay and the first 24 h in the PICU

(9) Ventilator-free days

Days alive and without invasive mechanical ventilation in the 28 days beginning at PICU admission will be recorded for the first PICU admission during each of the baseline and the post-randomization periods

Process of care

 

(1) ‘Stat’ calls to physicians

Requests for immediate specific physician attendance to provide patient care to a patient admitted to an inpatient ward

(2) Code Blue calls

Immediate medical assistance of the resuscitation team and equipment

(3) Urgent consultations to the ICU or MET-RRT

The total number of new consultation episodes will be counted. Patients who have been previously consulted on will be regarded as having a new consult if an urgent call is made that results in an unplanned or earlier than planned review. Planned review involves visits by the ICU team or the MET-RRT

(4) Documentation

The frequency with which each of the ‘vital’ signs (HR, RR, SBP, temperature) and the other four signs of the Bedside PEWS score (transcutaneous oxygen saturation, respiratory effort, oxygen therapy, capillary refill) is documented in 24 h will be recorded from five randomly selected patients each week

Resource utilization

 

Hospital length of stay

Will be assessed as the number of patient discharges divided by the number of patient days

following urgent ICU admission

 

ICU length of stay

This will be expressed as the number of whole or part study days (00:00:00 – 23:59:59) a given patient was in the ICU

Ventilator days

This is the number of whole or part study days of invasive mechanical ventilation

Dialysis

‘Dialysis’ will include hemo-filtration and hemodialysis techniques used either intermittently and continuously (or both), peritoneal dialysis, plasmaphersis and red-cell exchange

ECMO (days)

This is the number of whole or part study days of extracorporeal membrane oxygenation therapy provided during the ICU stay

Days with nitric oxide

This is the number of whole or part study days of inhaled nitric oxide therapy provided during the ICU stay

Perceptions of healthcare professionals

 

Documentation and interaction survey

A 10-min survey of frontline healthcare professionals to describe their perceptions of the utility of the current documentation system, the nature of inter-professional interactions and their background

Decision Maker Study exit survey

Eligible decision-makers will include: hospital chief executive officers (CEOs), chief nursing officers (CNOs), vice presidents and heads of a clinical department, divisions or services. Eligible services include senior nursing administrators for inpatient ward areas, resuscitation committee heads and medical emergency team leaders. At each hospital a maximum of ten eligible leaders will be selected by the EPOCH study team

A minimum of four decision-makers will be identified: the CEO, CNO, clinical head of pediatric surgery and clinical head of pediatric medicine. Hospitals with more than 80 beds will identify 2 additional decision-makers; hospitals with more than 120 beds will identify 4 additional decision-makers, and hospitals with more than 180 beds will identify an additional 6 decision-makers