Informing emergency care for all patients: The Registry for Emergency Care (REC) Project protocol.

OBJECTIVE: In Australia, the current ED burden related to COVID-19 is from 'suspected' rather than 'confirmed' cases. The initial aim of the Registry for Emergency Care (REC) Project is to determine the impact of isolation processes on the emergency care of all patients.
METHODS: The REC Project builds on the COVID-19 Emergency Department Quality Improvement (COVED) Project. Outcomes measured include times to critical assessment and management.
RESULTS: Clinical tools will be generated to inform emergency care, both during and beyond the COVID-19 pandemic.
CONCLUSIONS: The REC Project will support ED clinicians in the emergency care of all patients.

Background

The number of patients with suspected COVID‐19 presenting to EDs will fluctuate throughout 2020. Although the current burden of confirmed cases in Australia remains low, the pandemic has prompted important changes to clinical processes in the ED. There has been a widespread increase in the implementation of infection prevention and control (IPC) procedures and the establishment of isolation zones.

The ongoing impact of the pandemic is likely to be substantial, affecting the resource allocation, care pathways and outcomes of all patients, regardless of their COVID‐19 status. Further, the role of EDs in the syndromic surveillance for patients with communicable diseases will continue indefinitely.

Addressing these major and ongoing challenges will require robust systems for monitoring the presenting symptoms, assessment findings, management and outcomes for all patients presenting to the ED. Although efforts to inform the clinical and system‐level care of patients with suspected and confirmed COVID‐19 have been initiated, there is now a greater need for ED clinicians to understand the indirect effects of infection containment strategies, including the impact of IPC and isolation processes, to emergency care provision. The implementation of systems that monitor presentations and outcomes on an ongoing basis will increase resilience, improving the capacity of EDs to care for all patients with acute illness and/or injury, not just those patients with communicable diseases.

Aim

The aim of this manuscript is to introduce the Registry for Emergency Care (REC) study protocol. The first objective of the REC Project is to determine the impact of patient isolation and IPC processes on ED length of stay for adult patients. The complete list of medium‐term and specific objectives of the REC Project is provided in Box 1.

Methods

The REC Project is a prospective cohort study, with a series of nested cohort studies (each with a pre‐determined primary exposure and primary outcome). The current project site is the Alfred Hospital, Melbourne, with the opportunity for other Australian EDs to participate to form a REC network. The Alfred Hospital is a tertiary, adult, level 1 trauma centre with an ED census of approximately 70 000.

All patients presenting to the ED, aged 18 years or more, will be included. Outcomes measured will include ED length of stay, time to emergency procedures, ED disposition destination, ICU admission, the number of ventilator free days, hospital length of stay and hospital admission.

Variables to be collected will cover the spectrum of emergency care: demographics, presenting complaint plus comorbidities, processes of care (including time to emergency procedures), measures of severity (including first vital signs and triage category) and outcomes (including those listed above). The planned initial REC data set is described in Box 2. These variables build on the existing COVED Project and COVED Registry and are mostly consistent with the variables in the World Health Organization International Registry for Trauma and Emergency Care. The International Registry for Trauma and Emergency Care has been developed as an important resource to help deliver the recommendations of last year's World Health Assembly Resolution 72.16 globally, including across the Indo‐Pacific region. The REC list of variables is flexible to change as new data emerges regarding outcome predictors and treatment strategies. Up‐to‐date versions of the case report form and data dictionary will be made available on The Alfred's academic programmes website at www.emergencyeducation.org.au. This will facilitate standardisation of variables across other sites interested in participating.

Administrative data will be automatically exported from the Alfred Hospital's Electronic Medical Record; the data for the additional clinical variables will be captured from the tailored clinician form embedded in the Electronic Medical Record. All data will be entered into the novel REC utilising Research Electronic Data CAPture (REDCap) software (licensed to Monash University). , Analyses will be conducted to meet the objectives listed in Box 1.

The focus of the REC Project is consistent with guidance from the Australasian College for Emergency Medicine regarding research priorities during the COVID‐19 pandemic. Ethics approval for the REC Project was obtained from the Alfred Human Research Ethics Committee (Project No: 282/20) on 12 May 2020 and was registered with the Monash University Human Research Ethics Committee on 15 May 2020 (Project No: 24723).

Impact

The REC Project will inform real‐time improvements in ED care; it will determine the clinical predictors of patient‐centred outcomes for all patients seeking emergency care, and guide systems design, resource allocation and clinical management in order to meet current and future challenges. In the short‐term, it will help mitigate the indirect effects of COVID‐19 and the impact of virus containment strategies.

To monitor ED presentations for presenting complaints consistent with conditions of public health importance (e.g. syndromic surveillance for respiratory infections with epidemic potential).† Among all patients presenting to the ED (P), to determine and regularly monitor the impact of patient isolation (primary exposure variable (E)) during ED presentation versus no isolation (C) on clinical and system outcomes relevant to emergency care (O) (i.e. to use the REC to examine the impact of isolation for all ED presentations).‡ Among clinically identified subgroups of patients presenting to the ED (defined by triage category, presenting complaint, first vital signs and/or ED callout criteria) (P), to determine and regularly monitor the impact of isolation (primary exposure variable (E)) during a patient's ED presentation versus no isolation (C) on clinical and system outcomes relevant to emergency care (O) (i.e. to use the REC to examine the impact of isolation for selected clinical subgroups of ED presentations).† Among all and clinically identified subgroups of patients presenting to the ED (defined by triage category, presenting complaint, first vital signs and/or ED callout criteria) (P), to determine and regularly monitor additional predictors and risk factors (other than isolation in the ED) (E/C) for clinical and system outcomes relevant to emergency care (O) (i.e. to use the REC to guide and improve care for all ED patients).‡ To use the REC to provide useful, timely and regular (minimum of monthly) reports to inform and improve clinical care and system processes in the ED.‡

Phase 1 (0–3 months).

Phase 2 (>3 months). C, comparator variable; E, exposure variable; O, outcome variable; P, study population.

Variable	Type	Domain
Demographics and history
Age (years)	Continuous	18 to 120
Sex	Binary	Male or Female
Overseas travel†	Binary	Yes or No
Close contact with confirmed COVID‐19 case†	Binary	Yes or No
Residential care facility resident	Binary	Yes or No
Healthcare worker†	Binary	Yes or No
Pregnancy†	Binary	Yes or No
Comorbidities   Chronic respiratory disease   Chronic cardiac disease   Chronic hypertension   Diabetes mellitus   Smoker or ex‐smoker   Obesity   Current known cancer   Immunosuppression   Psychiatric illness‡   Other	Binary Binary Binary Binary Binary Binary Binary Binary Binary Free text	Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No
ED arrival
Interhospital transfer	Binary	Yes or No
Mode of arrival	Nominal	Types of transport
Triage category	Ordinal	1 to 5
Team callout‡   Trauma   Shocked trauma   Cardiac arrest   STEMI   Stroke   Sepsis   Behaviour of concern	Binary Binary Binary Binary Binary Binary Binary Binary	Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No Yes or No
First pain score‡	Ordinal	0 to 10
Isolation precautions in ED‡   Contact   Droplet   Airborne	Binary Binary Binary	Yes or No Yes or No Yes or No
Duration of time in isolation in ED‡	Continuous	0 to Maximum
Presenting complaint
Coryza†	Binary	Yes or No
Fever	Binary	Yes or No
Cough	Binary	Yes or No
Sore throat†	Binary	Yes or No
Acute dyspnoea	Binary	Yes or No
Acute diarrhoea	Binary	Yes or No
Acute muscle aches†	Binary	Yes or No
Acute fatigue†	Binary	Yes or No
Anosmia and/or dysgeusia†	Binary	Yes or No
Acute chest pain‡	Binary	Yes or No
Acute limb weakness‡	Binary	Yes or No
Acute injury‡	Binary	Yes or No
Acute altered conscious state (non‐injury)‡	Binary	Yes or No
Acute syncope‡	Binary	Yes or No
Acute abdominal pain‡	Binary	Yes or No
Acute anaphylaxis‡	Binary	Yes or No
Number of days since onset of first symptom	Continuous	0 to 28
Signs
Vital signs   Systolic blood pressure (mmHg)   Heart rate (beats/min)   Respiratory rate (breaths/min)   Temperature (degrees Celsius)   GCS   AVPU	Continuous Continuous Continuous Continuous Ordinal Ordinal	0–300 0–300 0–50 20–50 3–15 A, V, P or U
Pupil size‡	Continuous	0 to 20 mm
Pupil reactivity‡	Binary	Yes or No
Abnormalities on chest auscultation	Binary	Yes or No
Investigations
Time to first chest X‐ray (minutes)‡	Continuous	0 to Maximum
Abnormalities on chest X‐ray	Nominal	Abnormality and Type
Time to first CT scan (minutes)‡	Continuous	0 to Maximum
Abnormalities on chest CT†	Nominal	Abnormality and Type
Blood test results (ED)	Numerical	Test specific
SARS‐CoV‐2 test result in ED	Binary	Positive or negative
SARS‐CoV‐2 test result – subsequent as inpatient	Binary	Positive or negative
Management in the ED
Clinical impression (Severity)†	Ordinal	Mild to Extreme
Goals of care	Ordinal	A, B, C or D
Oxygen delivery methods in the ED   Nasal prongs†   Mask†   High flow nasal†   Non‐invasive ventilation   Invasive ventilation	Binary Binary Binary Binary Binary	Yes or No Yes or No Yes or No Yes or No Yes or No
Time of ETT in ED (minutes)‡	Continuous	0 to Maximum
Time NIV commenced in ED (minutes)‡	Continuous	0 to Maximum
Thoracostomy in ED‡	Binary	Yes or No
Time of thoracostomy in ED (minutes)‡	Continuous	0 to Maximum
Blood products in ED‡	Binary	Yes or No
Time blood product transfusion commenced in ED‡	Continuous	0 to Maximum
Antibiotics in ED‡	Binary	Yes or No
Time of first ED antibiotics‡	Continuous	0 to Maximum
Inotropes/vasopressors in ED‡	Binary	Yes or No
Time inotropes/vasopressors commenced in ED‡	Continuous	0 to Maximum
Time of first analgesia in ED‡	Continuous	0 to Maximum
Disposition
ED disposition	Nominal	Disposition destinations
Length of stay in ED (minutes)	Continuous	0 to Maximum
Mechanical ventilation during admission	Binary	Yes or No
Number of ventilation free days (days)	Continuous	0 to Maximum
Hospital length of stay (days)	Continuous	0 to Maximum
Death in hospital	Binary	Yes or No

For COVED Project only (i.e. patients where COVID‐19 swab is performed in ED).

For REC Project only (i.e. additional to COVED Project variables).