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

Sponsor
Hillerod Hospital, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT03268967
Collaborator
Holbaek Sygehus (Other)
1,800
1
2
57
31.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Structured admission procedure
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Before and after interventional studyBefore and after interventional study
Masking:
Single (Outcomes Assessor)
Masking Description:
Data analysis
Primary Purpose:
Health Services Research
Official Title:
Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. ICU length of stay (LOS) [through study completion, an average of 1 year]

      Days admitted at the ICU using registre data

    Secondary Outcome Measures

    1. Hospital length of stay (LOS) [At Hospital discharge within one-year before and after the intervention implementation]

      Days admitted to the hospital using registre data

    2. Line Sepsis [through study completion, an average of 1 year]

      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

    3. Ventilated associated pneumonia (VAP) [through study completion, an average of 1 year]

      Number of VAP measured by registre data

    4. Re-intubations [through study completion, an average of 1 year]

      Number of re-intubations measured by registre data

    5. 30-days Mortality [30 days through study completion, an average of 1 year]

      30-days mortality rates after ICU discharge measured by registre data

    6. 90-days Mortality [90 days through study completion, an average of 1 year]

      90-days mortality rates after ICU discharge measured by registre data

    7. Staff turn-over [through study completion, an average of 1 year]

      Staff turn-over before and after the intervention measured by registre data

    8. Sick Leave [through study completion, an average of 1 year]

      Sick leave amongst staff members measured by registre data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ICU admissions
    Exclusion Criteria:
    • None

    • Drop-out are deaths

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaestesiology Holbæk Denmark 4300

    Sponsors and Collaborators

    • Hillerod Hospital, Denmark
    • Holbaek Sygehus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janet Froulund Jensen, PHD, Principal Investigator, Hillerod Hospital, Denmark
    ClinicalTrials.gov Identifier:
    NCT03268967
    Other Study ID Numbers:
    • 113581
    • 113581
    First Posted:
    Aug 31, 2017
    Last Update Posted:
    Mar 9, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Janet Froulund Jensen, PHD, Principal Investigator, Hillerod Hospital, Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2018