- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633606
Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score
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?
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- admission to one of the 9 critical area's
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
most discriminative NAS cut off for identifying medium care patient versus intensive care patient
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Greet Van den Berghe, MD PhD, Catholic University Leuven
- Principal Investigator: Karen Decock, RS, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAS-ICU-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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