NCT03268967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

3.5 years

First QC Date

August 28, 2017

Last Update Submit

March 8, 2018

Conditions

Keywords

intensive carecrisis resource managementsimulation trainingbefore and after study

Outcome Measures

Primary Outcomes (1)

  • ICU length of stay (LOS)

    Days admitted at the ICU using registre data

    through study completion, an average of 1 year

Secondary Outcomes (8)

  • Hospital length of stay (LOS)

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

  • Line Sepsis

    through study completion, an average of 1 year

  • Ventilated associated pneumonia (VAP)

    through study completion, an average of 1 year

  • Re-intubations

    through study completion, an average of 1 year

  • 30-days Mortality

    30 days through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (2)

Structured Admission procedure

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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

Interventions

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
Structured Admission procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ICU admissions

You may not qualify if:

  • None
  • Drop-out are deaths

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaestesiology

Holbæk, 4300, Denmark

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysis
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Before and after interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, Principal Investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 31, 2017

Study Start

April 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 31, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations