Critical IllnessNCT03268967
Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
A study testing Structured admission procedure in people with Critical Illness, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Structured admission procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICU admissions
Who cannot join
- None
- Drop-out are deaths
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Critical Illness
- Being tested
- Structured admission procedure
- Keywords
- intensive care, crisis resource management, simulation training, before and after study
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured admission procedureBehavioural
Also called Standard Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay (LOS)
Days admitted at the ICU using registre data
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Hospital length of stay (LOS)
Days admitted to the hospital using registre data
Measured: 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
Measured: through study completion, an average of 1 year
Ventilated associated pneumonia (VAP)
Number of VAP measured by registre data
Measured: through study completion, an average of 1 year
Re-intubations
Number of re-intubations measured by registre data
Measured: through study completion, an average of 1 year
30-days Mortality
30-days mortality rates after ICU discharge measured by registre data
Measured: 30 days through study completion, an average of 1 year
90-days Mortality
90-days mortality rates after ICU discharge measured by registre data
Measured: 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
Measured: through study completion, an average of 1 year
Sick Leave
Sick leave amongst staff members measured by registre data
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Apr 2014
- Primary completion1 Oct 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and after interventional study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus
- Responsible party
- Principal investigator, Janet Froulund Jensen, Hillerod Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268967
- Sponsor's protocol ID
- 113581
- Other IDs
- 113581
- Status last verified
- Mar 2018
- First submitted
- 28 Aug 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
- ClinicalTrials.gov ID
- NCT03268967
- Acronym / sponsor ID
- 113581
- Conditions
- Critical Illness
- Keywords
- intensive care, crisis resource management, simulation training, before and after study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Holbaek Sygehus
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before and after interventional study
| Arm | Type | Receives |
|---|---|---|
| Structured Admission procedure | Active comparator | Behavioral: Structured admission procedureAfter 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 |
| Standard Care | No intervention | –Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ICU admissions
Key exclusion criteria (2 listed)
- None
- Drop-out are deaths
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured admission procedureAlso: Standard CareA 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. | Behavioural | Structured Admission procedure |
Primary outcome
ICU length of stay (LOS)
Time frame: through study completion, an average of 1 year
Days admitted at the ICU using registre data
8 secondary outcomes
Hospital length of stay (LOS)
Time frame: At Hospital discharge within one-year before and after the intervention implementation
Line Sepsis
Time frame: through study completion, an average of 1 year
Ventilated associated pneumonia (VAP)
Time frame: through study completion, an average of 1 year
Re-intubations
Time frame: through study completion, an average of 1 year
30-days Mortality
Time frame: 30 days through study completion, an average of 1 year
90-days Mortality
Time frame: 90 days through study completion, an average of 1 year
Staff turn-over
Time frame: through study completion, an average of 1 year
Sick Leave
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured admission procedure in people with Critical Illness, run by Hillerod Hospital, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay (LOS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.