Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: Structured admission procedure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holbæk, Denmark, 4300
    • Department of Anaestesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ICU admissions

Exclusion Criteria:

• None
• Drop-out are deaths

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Structured Admission procedure; 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	Behavioral: Structured admission procedure; 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.; Other Names: Standard Care
NO_INTERVENTION: Standard Care; Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay (LOS)	Days admitted at the ICU using registre data	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay (LOS)	Days admitted to the hospital using registre data	At Hospital discharge within one-year before and after the intervention implementation
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	through study completion, an average of 1 year
Ventilated associated pneumonia (VAP)	Number of VAP measured by registre data	through study completion, an average of 1 year
Re-intubations	Number of re-intubations measured by registre data	through study completion, an average of 1 year
30-days Mortality	30-days mortality rates after ICU discharge measured by registre data	30 days through study completion, an average of 1 year
90-days Mortality	90-days mortality rates after ICU discharge measured by registre data	90 days through study completion, an average of 1 year
Staff turn-over	Staff turn-over before and after the intervention measured by registre data	through study completion, an average of 1 year
Sick Leave	Sick leave amongst staff members measured by registre data	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hillerod Hospital, Denmark
• Collaborators: Holbaek Sygehus

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): August 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: intensive care; simulation training; crisis resource management; before and after study
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 113581 (OTHER_GRANT: Trygfonden)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No