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

Sponsor
Universiteit Antwerpen (Other)
Overall Status
Completed
CT.gov ID
NCT01949025
Collaborator
Belgian Federal Public Service, Food Chain Safety and Environment (Other)
69,656
1
2
39
1784.6

Study Details

Study Description

Brief 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 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.

  1. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ALARM intervention
N/A

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

Study Type:
Interventional
Actual Enrollment :
69656 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: ALARM intervention

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
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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. In-hospital unexpected death [Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]

  2. Unplanned ICU admission [Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]

  3. Cardiac arrest [Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All patients admitted to the partaking wards during the study period (October 1st 2013
  • September 30th 2015)
Exclusion Criteria:
  • Age: ≤ 16

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Antwerp Wilrijk Antwerp Belgium 2610

Sponsors and Collaborators

  • Universiteit Antwerpen
  • Belgian Federal Public Service, Food Chain Safety and Environment

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Filip Haegdorens, RN, MScN, PhD Candidate, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01949025
Other Study ID Numbers:
  • ALARM1
First Posted:
Sep 24, 2013
Last Update Posted:
Apr 26, 2017
Last Verified:
Apr 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2017