Early Warning Score Combined With Bedside Assessments: Accelerating Emergency Care To Improve Prognosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-09-16

Brief Summary

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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)

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Optimized ED Bedside Nursing Protocol

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.

Group Type EXPERIMENTAL

Optimized ED Bedside Nursing Protocol

Intervention Type PROCEDURE

A 3-minute standardized emergency nursing assessment exclusively performed by frontline ED nurses, integrating modified National Early Warning Score (mNEWS) and structured bedside checks. Implemented immediately after patient admission (pre-treatment initiation), it includes 2-minute evaluations of systolic BP, HR, RR, SpO₂, respiratory status, and GCS score, followed by 1-minute mNEWS calculation to stratify into low/medium/high risk-directly guiding care prioritization. Distinct from unstructured experience-based assessments or physician-led scoring tools, it's tailored for 24/7 shift-based cluster settings across multiple hospitals.

Control Arm: Conventional Emergency Assessment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Optimized ED Bedside Nursing Protocol

A 3-minute standardized emergency nursing assessment exclusively performed by frontline ED nurses, integrating modified National Early Warning Score (mNEWS) and structured bedside checks. Implemented immediately after patient admission (pre-treatment initiation), it includes 2-minute evaluations of systolic BP, HR, RR, SpO₂, respiratory status, and GCS score, followed by 1-minute mNEWS calculation to stratify into low/medium/high risk-directly guiding care prioritization. Distinct from unstructured experience-based assessments or physician-led scoring tools, it's tailored for 24/7 shift-based cluster settings across multiple hospitals.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No