AzTrials
AzTrials

Unexpected Hospital MortalityALARMNCT01949025

Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.

A study testing ALARM intervention in people with Unexpected Hospital Mortality and Death, Sudden, Cardiac, run by Universiteit Antwerpen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

1. Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's). Concerns have been raised that too often patients' acute deteriorations, particularly on surgical and medical wards outside critical care settings, are identified too late and… Read more about this study

Who is it for?
Ages 17 years and olderHealthy volunteers can take part
What is being tested?
ALARM intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69,656 participants
Where
1 siteBelgium
Study dates
Oct 2013to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age: ≤ 16

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • University of Antwerp

    Wilrijk, Antwerp, 2610

Other trials in Belgium

About this study

  1. Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's). Concerns have been raised that too often patients' acute deteriorations, particularly on surgical and medical wards outside critical care settings, are identified too late and corrective actions taken too slowly. Many initiatives have been taken to prevent unexpected death by timely recognition, intervention and resuscitation efforts such as Rapid Response Systems (RRS's). RRS's have been introduced with the intention to prevent SAE's and to improve patient outcome by facilitating early detection of warning signs for clinical deterioration. These systems have four components (1) an afferent limb for detection and response triggering, (2) an efferent limb with medical or nursing response to prevent deterioration (3) a process improvement limb and (4) a governance and administrative structure. It remains uncertain which elements of RRS's contribute most to patient outcomes such as unplanned (re-) admission to the intensive care unit, shock, cardiac arrest and unexpected death. In addition, previous studies found that nurse observation, assessment and communication (afferent limb) are crucial to achieve better patient outcomes, but how to achieve afferent limb sustainability in hospitals is not clear. A previous study investigated 23 hospitals in Flanders (Belgium) about how nurses observe, assess, detect and communicate deteriorating and critical patients in surgical, medical and geriatric wards. Wide variation between hospitals was identified about critical patient intervention procedures, strategies and Do Not Attempt Resuscitation (DNAR) orders as well as between nurses about the use and knowledge of critical vital signs and call criteria for physician clinical advice and support. Nurses of hospitals with structured observation and communication protocols were better informed and perceived their communication and collaboration with physicians more favorable in compared to other hospitals. Based on these results conclusions and recommendations for further initiatives were formulated. The proposed Afferent Limb and Response Method intervention study will implement these recommendations guided by a robust scientific research approach to offer evidence to the nursing and medical practice community. The aim of this study is to evaluate the effect of the Afferent Limb Ascertainment and Response Method intervention or ALARM intervention in medical and surgical nursing wards of acute care hospitals on the prevention of SAE's such as in-hospital unexpected death, unplanned ICU-admission and cardiac arrest.
  2. Study hypothesis

Optimizing and supporting the process of observation, use and interpretation of vital signs, detection, assessment, escalation and communication with a higher level of care in deteriorating patients can prevent serious adverse events (in-hospital unexpected death, unplanned ICU admission and cardiac arrest) in acute care hospitals.

Read the detailed description
  • What does the study involve?

The study is based on the application of training and tools: 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 (tools). A training team will offer standardized training sessions.

  • When does the study take place?

From October 1st 2013 till September 30th 2015.

  • Where does the study take place?

Belgium.

  • What are the risks to participants?

Patients will not be exposed to complementary risks if they partake in this study. No additional investigations will be performed for the purpose of this study since the aim of the intervention is to optimize existing processes that are already used in a hospital.

Being tested
ALARM intervention
Medical subject headings
Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALARM interventionOther

    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.

Study groups in NCT01949025
Study groupRoleWhat they receive
ALARM interventionExperimentalThe 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.
Receives: Other: ALARM intervention
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital unexpected death

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

  2. Unplanned ICU admission

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

  3. Cardiac arrest

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionSep 2015
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
69,656 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949025
Sponsor's protocol ID
ALARM1
Acronym
ALARM
Status last verified
Apr 2017
First submitted
17 Sep 2013
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24011975
  • 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.

    PubMed 31012124

Questions about this trial

What is this clinical trial studying?

A study testing ALARM intervention in people with Unexpected Hospital Mortality and Death, Sudden, Cardiac, run by Universiteit Antwerpen at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital unexpected death (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949025, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in