Early Warning Score Combined With Bedside Assessments: Accelerating Emergency Care To Improve Prognosis (EWS-BA)

Jun Liu

Status: Completed

Conditions: Process Optimization of Early Warning &Amp; Assessment for At-risk Emergency Patients; Acute Critical Illnesses in Emergency Settings

Treatments: Procedure: Optimized ED Bedside Nursing Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07249151

82302187 (Other Grant/Funding Number)

AHJN-NURS-20240917

Details and patient eligibility

About

Brief Summary This study, sponsored by the National Natural Science Foundation of China and conducted at the Emergency Department (ED) of Jiangnan University Affiliated Hospital, aims to optimize emergency care for critically ill patients via combining "early warning scoring" and "bedside rapid assessment".

Why the Study? Delayed identification of emergency patients at high risk of deterioration worsens outcomes; traditional assessments often miss subtle deterioration signs. This study seeks a more efficient assessment approach to help clinicians recognize high-risk patients earlier and start targeted treatment faster.

Eligibility 200-300 participants will be recruited from the hospital's ED for acute diseases (e.g., severe infection, heart failure, trauma). Inclusion: aged 18-80, with informed consent (or family consent if unable to communicate). Exclusion: severe mental illness, non-intervenable terminal illness.

Study Process All participants receive routine emergency care. The research team uses a new combined assessment tool: first a 2-minute bedside rapid assessment (vital signs, consciousness, breathing), then early warning scoring to classify risk. Doctors adjust treatment priority based on results. The team records time from admission to treatment initiation and 72-hour condition changes. No additional invasive procedures/experimental drugs are used, and no extra cost for assessments.

Potential Benefits Participants may get more timely, targeted emergency care (reducing deterioration risk and hospital stay). Study results will improve emergency care at this and other hospitals, benefiting more emergency patients.

Study Leadership Principal Investigator: Dr. Jun Liu (Attending Physician, ED of Jiangnan University Affiliated Hospital) Responsible Party: Jiangnan University Affiliated Hospital (Sponsor) Ethical Approval: Approved by the hospital's Medical Ethics Committee (Approval No.: To be filled with actual number)

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients will be eligible for enrollment if they meet all of the following conditions:

1. Age between 18 and 80 years at the time of presentation.
2. Presentation to the emergency department (ED) for acute medical evaluation.
3. Completion of at least one documented Early Warning Score (EWS) assessment upon ED admission or during the ED stay.

Exclusion criteria

Patients will be excluded if they meet any of the following criteria:

1. Do-not-resuscitate (DNR) orders or enrollment in a palliative/comfort care pathway at the time of presentation.

2. Cardiac arrest upon arrival to the ED (unresponsive, pulseless, requiring resuscitation without return of spontaneous circulation).

3. Transfer out of the hospital (to another institution or to the operating room for immediate surgery) within 24 hours of ED admission.

4. History of major cardiac surgery (e.g., coronary artery bypass grafting, valve replacement) or heart transplantation, as these conditions may alter baseline hemodynamics and limit EWS applicability.

5. Severe chronic organ dysfunction, including:

   End-stage renal disease requiring maintenance dialysis; Severe hepatic insufficiency (Child-Pugh class C or equivalent); Advanced heart failure (New York Heart Association class IV).

6. Known allergy or contraindication to iodinated contrast media (if relevant laboratory or imaging assessments are required for outcome evaluation).

7. Pregnancy, due to altered physiological parameters and ethical considerations.

8. Incomplete or missing clinical records, preventing calculation of EWS or confirmation of study endpoints.

9. Duplicate enrollment due to repeated ED visits or readmissions during the study period (only the first eligible admission will be included).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Optimized ED Bedside Nursing Protocol

Experimental group

Description:

Arm 1 (Intervention: Optimized ED Assessment) 12 clusters (3 hospitals × 6 depts, day/night shifts) randomized to intervention in 10 phases. Participants get "mNEWS + structured bedside rapid assessment" at triage: 3-min standard assessment (2-min checks: BP, HR, RR, SpO₂, GCS, respiratory status; 1-min mNEWS for risk stratification). Staff prioritize treatment via results. Optimized protocol replaces conventional post-randomization.

Treatment:

Procedure: Optimized ED Bedside Nursing Protocol

Control Arm: Conventional Emergency Assessment

No Intervention group

Description:

Control: Conventional ED Assessment Waitlist clusters keep routine assessment pre-randomization. Conventional process: vital sign recording (BP, HR, RR) + subjective severity judgment, no structured scoring/risk stratification. Clusters switch to optimized post-wait, but control data collected only during conventional implementation.