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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Universiteit Antwerpen
Sponsor:
Collaborator:
Belgian Federal Public Service, Food Chain Safety and Environment
Information provided by (Responsible Party):
Filip Haegdorens, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01949025
First received: September 17, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose
  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.


Condition Intervention
Unexpected Hospital Mortality
Death, Sudden, Cardiac
Unplanned Intensive Care Unit Admission
Other: ALARM intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • In-hospital unexpected death [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]
  • Unplanned ICU admission [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]
  • Cardiac arrest [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100000
Study Start Date: October 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949025

Contacts
Contact: Filip Haegdorens, RN, MScN, PhD Candidate 0032497769040 filip.haegdorens@student.uantwerpen.be
Contact: Peter Van Bogaert, RN, MA, PhD 003232652504 peter.vanbogaert@uantwerpen.be

Locations
Belgium
University of Antwerp Recruiting
Wilrijk, Antwerp, Belgium, 2610
Contact: Peter Van Bogaert, RN, MA, PhD    003232652504    peter.vanbogaert@uantwerpen.be   
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
  More Information

Additional Information:
Publications:
Responsible Party: Filip Haegdorens, RN, MScN, PhD Candidate, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01949025     History of Changes
Other Study ID Numbers: ALARM1
Study First Received: September 17, 2013
Last Updated: July 15, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Additional relevant MeSH terms:
Death, Sudden
Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014