NCT02336828

Brief Summary

This study is to validate the use of the modified early warning score (MEWS) in an adult oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will be associated with an increased risk of death or ICU admission, and should be regarded as a MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and aggressive management of life-threatening complications in oncology patients, results in dramatic improvements in overall survival rates. This is a prospective, single centre, observational, cohort study. Objective of this study is to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day mortality in adult clinical oncology ward patients. The alternate hypothesis of this study is a significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm. The null hypothesis is a no significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm. The primary outcome measure in this study is the number of patients who die within 7 days of a MEWS Alarm (7 day mortality). The secondary outcome measure in this study is the number of patients admitted to ICU within 7 days of a MEWS Alarm.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

January 8, 2015

Last Update Submit

January 23, 2015

Conditions

Keywords

MEWSdeteriorateoncologyICUpredicting outcomesMEWS in predicting outcomes in oncology patients

Outcome Measures

Primary Outcomes (1)

  • The number of patients who die within 7 days of a MEWS Alarm (7 day mortality).

    The 7 day mortality was counted from the on set of reaching the MEWS Alarm

Secondary Outcomes (1)

  • The number of patients admitted to ICU within 7 days of a MEWS Alarm.

    The 7 day ICU admission was counted from the on set of reaching the MEWS Alarm

Study Arms (1)

MEWS alarm and mortality

Reach MEWS Alarm, Not reach MEWS Alarm, With 7 day mortality, Without 7 day mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical oncology ward adult patients

You may qualify if:

  • The patients consecutively admitted to clinical oncology ward from 18 January to 7 February 2015 are included in the study.

You may not qualify if:

  • The patients with incomplete MEWS or discharge data are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

EmergenciesNeoplasms

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AU HANG CHING

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations