Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
Primary Purpose
Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Structured admission procedure
Sponsored by
About this trial
This is an interventional health services research trial for Critical Illness focused on measuring intensive care, crisis resource management, simulation training, before and after study
Eligibility Criteria
Inclusion Criteria:
- ICU admissions
Exclusion Criteria:
- None
- Drop-out are deaths
Sites / Locations
- Department of Anaestesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Structured Admission procedure
Standard Care
Arm Description
After implementation of a structured admission procedure to all ICU patients inspired by principles of Crisis Resource Management, Closed loop communication, action cards, and staff simulation training
Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.
Outcomes
Primary Outcome Measures
ICU length of stay (LOS)
Days admitted at the ICU using registre data
Secondary Outcome Measures
Hospital length of stay (LOS)
Days admitted to the hospital using registre data
Line Sepsis
Treatment package of number of the line sepsis after ICU admission covering the number of patients with line sepsis using registre data on Lactat <1 hour, bacteria samples ≤1 hour taken, time between diagnosis of sepsis and taken bacteria samples, time between diagnosis and given antibiotics measured by registre data
Ventilated associated pneumonia (VAP)
Number of VAP measured by registre data
Re-intubations
Number of re-intubations measured by registre data
30-days Mortality
30-days mortality rates after ICU discharge measured by registre data
90-days Mortality
90-days mortality rates after ICU discharge measured by registre data
Staff turn-over
Staff turn-over before and after the intervention measured by registre data
Sick Leave
Sick leave amongst staff members measured by registre data
Full Information
NCT ID
NCT03268967
First Posted
August 28, 2017
Last Updated
March 8, 2018
Sponsor
Hillerod Hospital, Denmark
Collaborators
Holbaek Sygehus
1. Study Identification
Unique Protocol Identification Number
NCT03268967
Brief Title
Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
Official Title
Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hillerod Hospital, Denmark
Collaborators
Holbaek Sygehus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Admission to the intensive care unit (ICU) is vital for surviving critical illness. An admission to ICU without having a consistent structure, structured review of the patient and a solid team organization lead to unclear communication and responsibility. Factors that correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was that a structured admission can improve patients safety, reduce delays in treatment, reduce ICU length of stay, and improve mortality rate. The overall objective was to optimize patient safety, and effectively use available resources to reduce admission time, delays in treatment and procedures and mortality by using both quantitative and qualitative methods.
Detailed Description
The quantitative before-data is a one-year observational period prior to the intervention measured by different perspectives; patients and staff outcomes.
After the intervention, was qualititive data collected from participants, who received simulation training.
The quantitative after-data is a one-year observational period post-intervention with same outcomes as before starting the intervention.
Data is already collected registry data from hospital quality assurance board. Data will be compared before and after with assessor blinded analysis. Missing data will not be replaced but reported as missing.
The investigators will try to compare the results with data from an approximately comparative ICU in Denmark due to the implementation of a new patient management system called the Health Portal.
The statistical analysis plan is based on descriptive and comparative analyses of the group before and after the trial. The quantitative results are explained in in-depths description from participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
intensive care, crisis resource management, simulation training, before and after study
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before and after interventional study
Masking
Outcomes Assessor
Masking Description
Data analysis
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured Admission procedure
Arm Type
Active Comparator
Arm Description
After implementation of a structured admission procedure to all ICU patients inspired by principles of Crisis Resource Management, Closed loop communication, action cards, and staff simulation training
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Structured admission procedure
Other Intervention Name(s)
Standard Care
Intervention Description
A structured ICU admission was inspired by principles of Crisis Resource Management and simulation training of ICU staff members. The Principles of Crisis Resource Management consisted of a treatment manual, a learning video, clear precise communication tool based on Identification-Situation-Background-Analysis-Recommendations (ISBAR) and Closed loop, actions cards, and ABCDE-evaluation of the patient including debriefing, and training in the simulation environment.
Primary Outcome Measure Information:
Title
ICU length of stay (LOS)
Description
Days admitted at the ICU using registre data
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Hospital length of stay (LOS)
Description
Days admitted to the hospital using registre data
Time Frame
At Hospital discharge within one-year before and after the intervention implementation
Title
Line Sepsis
Description
Treatment package of number of the line sepsis after ICU admission covering the number of patients with line sepsis using registre data on Lactat <1 hour, bacteria samples ≤1 hour taken, time between diagnosis of sepsis and taken bacteria samples, time between diagnosis and given antibiotics measured by registre data
Time Frame
through study completion, an average of 1 year
Title
Ventilated associated pneumonia (VAP)
Description
Number of VAP measured by registre data
Time Frame
through study completion, an average of 1 year
Title
Re-intubations
Description
Number of re-intubations measured by registre data
Time Frame
through study completion, an average of 1 year
Title
30-days Mortality
Description
30-days mortality rates after ICU discharge measured by registre data
Time Frame
30 days through study completion, an average of 1 year
Title
90-days Mortality
Description
90-days mortality rates after ICU discharge measured by registre data
Time Frame
90 days through study completion, an average of 1 year
Title
Staff turn-over
Description
Staff turn-over before and after the intervention measured by registre data
Time Frame
through study completion, an average of 1 year
Title
Sick Leave
Description
Sick leave amongst staff members measured by registre data
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ICU admissions
Exclusion Criteria:
None
Drop-out are deaths
Facility Information:
Facility Name
Department of Anaestesiology
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
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