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.
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
- Conditions the study is for
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- 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.
About this study
- 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.
- 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.
- Conditions
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ALARM intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital unexpected death
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Unplanned ICU admission
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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.
- First posted24 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unexpected Hospital MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment
- Responsible party
- Principal investigator, Filip Haegdorens, Universiteit Antwerpen
- Investigators
- Filip Haegdorens, RN, MScN, PhD Candidate, Principal investigator, Universiteit AntwerpenPeter Van Bogaert, RN, MA, PhD, Study chair, Universiteit AntwerpenKoenraad G. Monsieurs, MD, PhD, Study chair, Universiteit AntwerpenKoen De Meester, RN, MScN, PhD, Study chair, Universiteit Antwerpen
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 24011975Haegdorens 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
- ClinicalTrials.gov ID
- NCT01949025
- Acronym / sponsor ID
- ALARM / ALARM1
- Conditions
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69,656 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALARM intervention | Experimental | Other: ALARM interventionThe 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 intervention | – |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the partaking wards during the study period (October 1st 2013 - September 30th 2015)
Key exclusion criteria (1 listed)
- Age: ≤ 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALARM interventionThe 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 |
Primary outcome
In-hospital unexpected death
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Unplanned ICU admission
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiac arrest
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 24011975De 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.
- Derived from this study: PubMed 31012124Haegdorens 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 InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Haegdorens, RN, MScN, PhD Candidate principal investigator
Universiteit Antwerpen
Peter Van Bogaert, RN, MA, PhD study chair
Universiteit Antwerpen
Koenraad G. Monsieurs, MD, PhD study chair
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
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.