Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
ALARM
1 other identifier
interventional
69,656
1 country
1
Brief Summary
- 1.Summary
- 2.Study hypothesis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedApril 26, 2017
April 1, 2017
1.9 years
September 17, 2013
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
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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
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: 24011975BACKGROUNDHaegdorens 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.
PMID: 31012124DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Haegdorens, RN, MScN, PhD Candidate
Universiteit Antwerpen
- STUDY CHAIR
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 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