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Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department (NEWS-1-TRIPS)

Primary Purpose

Sepsis, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
2018 Surviving Sepsis Campaign Hour-1 Bundle
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, National Early Warning Score, Surviving Sepsis Campaign Hour-1 Bundle, Emergency Department, Implementation Sciences

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ED patients aged ≥ 18 years who fulfil ALL of the following criteria: a clinical diagnosis of infection made by the treating emergency physicians require hospital admission a NEWS2 ≥ 5 Exclusion Criteria: age < 18 years currently pregnant neutropenic or post-chemotherapy fever, for which ED protocols for early antibiotics apply an advanced directive with a ceiling-of-care refusal of consent/pre-existing mental illness rendering consent impossible refusal of hospitalization

Sites / Locations

  • Accident and Emergency Department, Pamela Youde Nethersole Eastern HospitalRecruiting
  • Accident and Emergency Department, Prince of Wales HospitalRecruiting
  • Accident and Emergency Department, Queen Mary HospitalRecruiting
  • Accident and Emergency Department, Tuen Mun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NEWS-1 care

Standard care

Arm Description

During the interventional period, the 2018 Sepsis Hour-1 Bundle will be initiated in the ED if NEWS2 score ≥ 5.

During the standard care period, emergency physicians will assess the patients based on history, physical examination, laboratory tests, chest radiography or other imaging studies, and will offer treatment based on clinical expertise, intuition, and local or international guidelines

Outcomes

Primary Outcome Measures

All-cause 30-day mortality
The number of patients who die over 30 days

Secondary Outcome Measures

All-cause in-hospital mortality
The number of patients who die during the index hospitalization
All-cause 90-day mortality
The number of patients who die over 90 days
Sepsis-related in-hospital mortality
The number of patients who die during the index hospitalization because of sepsis, as judged by an independent emergency physician and an infectious disease specialist based on review of clinical notes and autopsy findings, if available
Intensive care unit admission
Number of participants who require intensive care unit admission during the index hospitalization
Ventilator-free days over 30 days
The number of ventilator-free days over 30 days after recruitment
The need for renal replacement therapy
The number of patients who require renal replacement therapy during the index hospitalization that is not due to pre-existing renal failure
The total length of stay in the emergency department
The total number of hour of patient stay in the emergency department
The total length of stay in the intensive care unit
The total number of days of patient stay in the intensive care unit
The total length of stay in the general ward
The total number of days of patient stay in the general ward
The time to surgery
The number of hours from ED registration to the first surgery for cases who receive surgery during the index hospitalization

Full Information

First Posted
January 26, 2023
Last Updated
August 9, 2023
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Tuen Mun Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05731349
Brief Title
Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department
Acronym
NEWS-1-TRIPS
Official Title
Impact of Early Sepsis Care With the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the Emergency Department: A Hybrid Type 1 Effectiveness-Implementation Pilot Study (NEWS-1 Trial Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Tuen Mun Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are: Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial? Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5? What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings? Participants will receive the following SSC Hour-1 Bundle care during the intervention period: Blood lactate level measurement Blood cultures collection before administering antibiotics Broad-spectrum antibiotics Intravenous fluid Vasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHg Researchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.
Detailed Description
Despite international endorsement and promulgation, the uptake of the sepsis-care bundles remains low across health-care settings. In most cases, clinicians are still offering sepsis care based on individual clinical judgement, intuition, skills, and available time and resources, leading to a variable standard of care at best and a suboptimal patient outcome in many cases. Significant knowledge gaps exist in the real-world effectiveness of sepsis bundles that are objectively triggered by the early warning score and in the best implementation strategy of sepsis bundle in the ED setting. The sepsis care model in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS2 score (≥ 5) (known as "NEWS-1 care" in this study) will be evaluated in this study. This pilot study is a type 1 hybrid effectiveness-implementation study, which contains all the major components of a planned full-scale trial intended to involve a larger sample size from more local EDs. This pilot study has three essential components: First, the effectiveness component will evaluate the effect of the SSC Hour-1 Bundle in reducing 30-day all-cause mortality in adult patients presenting to the ED with a clinical diagnosis of infection and a NEWS2 ≥ 5. A prospective, stepped-wedge, cluster-randomized trial, which combines elements of a standard cluster-randomized design (intervention applied in clusters) and a before-after design (in which each cluster switches to the intervention), will be conducted in four EDs in Hong Kong. All study sites will start with an initial period of standard care; they will then switch in random order at intervals of two months to the NEWS-1 care in a unidirectional fashion until all hospitals have crossed over. Recruitment will continue in all study sites until the end of the trial. Second, the implementation component will use a mixed-methods design to evaluate the uptake of the SSC Hour-1 Bundle using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, and determine the barriers to and facilitators of its implementation in daily practice. Third, the investigators will evaluate the acceptability, feasibility and practicability of a full-scale effectiveness-implementation trial based on the 14 progression criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Sepsis, National Early Warning Score, Surviving Sepsis Campaign Hour-1 Bundle, Emergency Department, Implementation Sciences

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-wedge, cluster-randomized trial
Masking
None (Open Label)
Masking Description
Masking is not feasible given the study design
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEWS-1 care
Arm Type
Experimental
Arm Description
During the interventional period, the 2018 Sepsis Hour-1 Bundle will be initiated in the ED if NEWS2 score ≥ 5.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
During the standard care period, emergency physicians will assess the patients based on history, physical examination, laboratory tests, chest radiography or other imaging studies, and will offer treatment based on clinical expertise, intuition, and local or international guidelines
Intervention Type
Other
Intervention Name(s)
2018 Surviving Sepsis Campaign Hour-1 Bundle
Intervention Description
Measure lactate Obtain blood cultures before administering antibiotics Administer broad-spectrum antibiotics based on local guidelines Begin fluid resuscitation with up to 30 mL/kg crystalloid for hypotension or lactate level ≥ 4 mmol/L. Apply vasopressors if hypotensive during or after fluid resuscitation to maintain the MAP ≥ 65 mm Hg
Primary Outcome Measure Information:
Title
All-cause 30-day mortality
Description
The number of patients who die over 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All-cause in-hospital mortality
Description
The number of patients who die during the index hospitalization
Time Frame
From the date of recruitment until the date of death from any cause or date of hospital discharge, whichever comes first, assessed up to 90 days
Title
All-cause 90-day mortality
Description
The number of patients who die over 90 days
Time Frame
90 days
Title
Sepsis-related in-hospital mortality
Description
The number of patients who die during the index hospitalization because of sepsis, as judged by an independent emergency physician and an infectious disease specialist based on review of clinical notes and autopsy findings, if available
Time Frame
From the date of recruitment until the date of death from sepsis or date of hospital discharge, whichever comes first, assessed up to 90 days
Title
Intensive care unit admission
Description
Number of participants who require intensive care unit admission during the index hospitalization
Time Frame
From the date of recruitment until the date of first documented intensive care unit admission or date of hospital discharge or date of death, whichever comes first, assessed up to 90 days
Title
Ventilator-free days over 30 days
Description
The number of ventilator-free days over 30 days after recruitment
Time Frame
Over 30 days following recruitment
Title
The need for renal replacement therapy
Description
The number of patients who require renal replacement therapy during the index hospitalization that is not due to pre-existing renal failure
Time Frame
From the date of recruitment until the date of first documented renal replacement therapy or date of hospital discharge or date of death, whichever comes first, assessed up to 90 days
Title
The total length of stay in the emergency department
Description
The total number of hour of patient stay in the emergency department
Time Frame
From the time of emergency department registration to the time of check out from the emergency department or time of death in the emergency department, whichever comes first, assessed up to 7 days
Title
The total length of stay in the intensive care unit
Description
The total number of days of patient stay in the intensive care unit
Time Frame
From the date of intensive care unit admission until the date of discharge from the intensive care unit or date of death, whichever comes first, assessed up to 90 days
Title
The total length of stay in the general ward
Description
The total number of days of patient stay in the general ward
Time Frame
From the date of hospital admission to general ward until the date of hospital discharge or date of transfer out of general ward or date of death, whichever comes first, assessed up to 90 days
Title
The time to surgery
Description
The number of hours from ED registration to the first surgery for cases who receive surgery during the index hospitalization
Time Frame
From the of emergency department registration until the first documented time of surgery or time of hospital discharge or time of death, whichever comes first, assessed up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ED patients aged ≥ 18 years who fulfil ALL of the following criteria: a clinical diagnosis of infection made by the treating emergency physicians require hospital admission a NEWS2 ≥ 5 Exclusion Criteria: age < 18 years currently pregnant neutropenic or post-chemotherapy fever, for which ED protocols for early antibiotics apply an advanced directive with a ceiling-of-care refusal of consent/pre-existing mental illness rendering consent impossible refusal of hospitalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Kin Lam, MBBS, MPH
Phone
852 3917 9413
Email
lampkrex@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pui Kin Lam, MBBS, MPH
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Accident and Emergency Department, Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rex Pui Kin Lam, MBBS, MPH
Facility Name
Accident and Emergency Department, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rex Pui Kin Lam, MBBS, MPH
Facility Name
Accident and Emergency Department, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rex Pui Kin Lam, MBBS, MPH
Facility Name
Accident and Emergency Department, Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rex Pui Kin Lam, MBBS, MPH

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators will need to seek additional approval from the Institutional Review Boards of all study hospitals for release of de-identified data.

Learn more about this trial

Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department

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