Critical IllnessNCT01633606
Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score
An observational study of Critical Illness, run by KU Leuven.
Trial summary
The aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Sep 2013
- Phase
- Observational
- 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
Study population: acute patients
Who may be able to join
- admission to one of the 9 critical area's
Who cannot join
None listed.
About this study
The aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing.
The main study question is: What is the most discriminative NAS cut off for medium care patient?
Read more
Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is admitted to the 8 participating units.
Nurses will be asked to answer 3 questions (see detailed description here under)at the end of their working shift concerning each patient appointed to them.
Each morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward.
In order to determine the NAS cut off for medium care patient, all morning questionnaire scores will be compared to the NAS an TISS28 scores of that same morning.
Secondary study questions are:
- Can NAS score based on one nursing shift predict the severity of care in the subsequent nursing shift?
- Is there a difference in appreciation of severity of care between nurses, head nurses and medical staff?
- Which variables influence the perception of severity of care?
- How does NAS relate to TISS28, APACHE and NEMS?
Read the detailed description
Nursing questionnaire:
- How many beds were appointed to you?
- 1
- 2
- 3
- 4
- 5
- 6
- For how many of such patients you could care for maximally?
- 1
- 2
- 3
- 4
- >4
- This patients' burden of care corresponds to:
- An intensive care patient who requires more than standard intensive care
- An intensive care patient who requires standard intensive care
- A medium care patient medical staff and head nurse questionaire:
- For how many of such patients you could care for maximally?
- 1
- 2
- 3
- 4
- >4
- This patients' burden of care corresponds to?
- An intensive care patient who requires more than standard intensive care
- An intensive care patient who requires standard intensive care
- A medium care patient
- Conditions
- Critical Illness
- Keywords
- severity of illness, scoring, medium care, intensive care, staffing
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute patients | Patients admitted to the surgical and general ICU (including burn unit), to the coronary care unit, to the emergency department high care zone, to the medical ICU, to the medical medium care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
most discriminative NAS cut off for identifying medium care patient versus intensive care patient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
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.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greet Van den Berghe, KU Leuven
- Investigators
- Greet Van den Berghe, MD PhD, Study director, Catholic University LeuvenKaren Decock, RS, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633606
- Sponsor's protocol ID
- NAS-ICU-2012
- Status last verified
- Jan 2014
- First submitted
- 2 Jul 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score
- ClinicalTrials.gov ID
- NCT01633606
- Acronym / sponsor ID
- NAS-ICU-2012
- Conditions
- Critical Illness
- Keywords
- severity of illness, scoring, medium care, intensive care, staffing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Jul 2012 (estimated)
- 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.
The aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing.
The main study question is: What is the most discriminative NAS cut off for medium care patient?
Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is admitted to the 8 participating units.
Nurses will be asked to answer 3 questions (see detailed description here under)at the end of their working shift concerning each patient appointed to them.
Each morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward.
In order to determine the NAS cut off for medium care patient, all morning questionnaire scores will be compared to the NAS an TISS28 scores of that same morning.
Secondary study questions are:
- Can NAS score based on one nursing shift predict the severity of care in the subsequent nursing shift?
- Is there a difference in appreciation of severity of care between nurses, head nurses and medical staff?
- Which variables influence the perception of severity of care?
- How does NAS relate to TISS28, APACHE and NEMS?
Detailed description
Nursing questionnaire:
- How many beds were appointed to you?
- 1
- 2
- 3
- 4
- 5
- 6
- For how many of such patients you could care for maximally?
- 1
- 2
- 3
- 4
- >4
- This patients' burden of care corresponds to:
- An intensive care patient who requires more than standard intensive care
- An intensive care patient who requires standard intensive care
- A medium care patient medical staff and head nurse questionaire:
- For how many of such patients you could care for maximally?
- 1
- 2
- 3
- 4
- >4
- This patients' burden of care corresponds to?
- An intensive care patient who requires more than standard intensive care
- An intensive care patient who requires standard intensive care
- A medium care patient
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute patients | – | –Patients admitted to the surgical and general ICU (including burn unit), to the coronary care unit, to the emergency department high care zone, to the medical ICU, to the medical medium care unit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute patients
Key inclusion criteria (1 listed)
- admission to one of the 9 critical area's
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
most discriminative NAS cut off for identifying medium care patient versus intensive care patient
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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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.
Greet Van den Berghe, MD PhD study director
Catholic University Leuven
Karen Decock, RS principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by KU Leuven.
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 0 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: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
most discriminative NAS cut off for identifying medium care patient versus intensive care patient (time frame: 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 29 Jan 2014.