Death, Sudden, Cardiac Clinical Trial
Official title:
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention 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.
- 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.
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