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Status unknownNCT03268967Updated Mar 9, 2018

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

An interventional study of Structured admission procedure in Critical Illness, sponsored by Hillerod Hospital, Denmark. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Hillerod Hospital, Denmark · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Apr 2014, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
1,800
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Critical Illness

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Keywords

  • intensive care
  • crisis resource management
  • simulation training
  • before and after study
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 90 across 926 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hillerod Hospital, Denmark is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ICU admissions

Exclusion criteria

Exclusion Criteria:

  • None
  • Drop-out are deaths
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
1,800 participants (estimated)

Study arms

  • 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

  • No intervention
    Standard Care

    Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention.

Interventions

  • BehavioralStructured 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.

    Also known as: Standard Care

06

What researchers measure

Primary outcomes

  1. ICU length of stay (LOS)

    Days admitted at the ICU using registre data

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Hospital length of stay (LOS)

    Days admitted to the hospital using registre data

    Time frame: At Hospital discharge within one-year before and after the intervention implementation

  2. 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

    Time frame: through study completion, an average of 1 year

  3. Ventilated associated pneumonia (VAP)

    Number of VAP measured by registre data

    Time frame: through study completion, an average of 1 year

  4. Re-intubations

    Number of re-intubations measured by registre data

    Time frame: through study completion, an average of 1 year

  5. 30-days Mortality

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

    Time frame: 30 days through study completion, an average of 1 year

  6. 90-days Mortality

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

    Time frame: 90 days through study completion, an average of 1 year

  7. Staff turn-over

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

    Time frame: through study completion, an average of 1 year

  8. Sick Leave

    Sick leave amongst staff members measured by registre data

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Department of Anaestesiology
    Holbæk, 4300, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03268967
Lead sponsor
Hillerod Hospital, Denmark
Collaborators
Holbaek Sygehus
Responsible party
Janet Froulund Jensen (PHD, Principal Investigator, Hillerod Hospital, Denmark) — Principal investigator
First posted
Aug 31, 2017
Start date
Apr 1, 2014
Primary completion
Oct 1, 2017
Completion
Dec 31, 2018 (estimated)
Last update
Mar 9, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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