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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03268967
• Other study ID #: 113581
• Secondary ID: 113581
• Status: Active, not recruiting
• Phase: N/A
• First received: August 28, 2017
• Last updated: March 8, 2018
• Start date: April 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ICU admissions

Exclusion Criteria:

• Drop-out are deaths

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Anaestesiology	Holbæk

Sponsors (2)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark	Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU length of stay (LOS)	Days admitted at the ICU using registre data	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Ventilated associated pneumonia (VAP)	Number of VAP measured by registre data	through study completion, an average of 1 year
Secondary	Re-intubations	Number of re-intubations measured by registre data	through study completion, an average of 1 year
Secondary	30-days Mortality	30-days mortality rates after ICU discharge measured by registre data	30 days through study completion, an average of 1 year
Secondary	90-days Mortality	90-days mortality rates after ICU discharge measured by registre data	90 days through study completion, an average of 1 year
Secondary	Staff turn-over	Staff turn-over before and after the intervention measured by registre data	through study completion, an average of 1 year
Secondary	Sick Leave	Sick leave amongst staff members measured by registre data	through study completion, an average of 1 year