NCT01949025

Brief Summary

  1. 1.Summary
  2. 2.Study hypothesis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69,656

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

September 17, 2013

Last Update Submit

April 24, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • In-hospital unexpected death

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Unplanned ICU admission

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Cardiac arrest

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

ALARM intervention

EXPERIMENTAL

The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.

Other: ALARM intervention

Control group

NO INTERVENTION

Interventions

The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.

ALARM intervention

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to the partaking wards during the study period (October 1st 2013 - September 30th 2015)

You may not qualify if:

  • Age: ≤ 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Antwerp

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (2)

  • De Meester K, Haegdorens F, Monsieurs KG, Verpooten GA, Holvoet A, Van Bogaert P. Six-day postoperative impact of a standardized nurse observation and escalation protocol: a preintervention and postintervention study. J Crit Care. 2013 Dec;28(6):1068-74. doi: 10.1016/j.jcrc.2013.07.061. Epub 2013 Sep 6.

    PMID: 24011975BACKGROUND
  • Haegdorens F, Monsieurs KG, De Meester K, Van Bogaert P. An intervention including the national early warning score improves patient monitoring practice and reduces mortality: A cluster randomized controlled trial. J Adv Nurs. 2019 Sep;75(9):1996-2005. doi: 10.1111/jan.14034. Epub 2019 Jun 6.

Related Links

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Filip Haegdorens, RN, MScN, PhD Candidate

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR
  • Peter Van Bogaert, RN, MA, PhD

    Universiteit Antwerpen

    STUDY CHAIR
  • Koenraad G. Monsieurs, MD, PhD

    Universiteit Antwerpen

    STUDY CHAIR
  • Koen De Meester, RN, MScN, PhD

    Universiteit Antwerpen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MScN, PhD Candidate

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 24, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

January 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations