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Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633606
First Posted: July 4, 2012
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
  Purpose

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?

Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score

Further study details as provided by Greet Van den Berghe, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • most discriminative NAS cut off for identifying medium care patient versus intensive care patient [ Time Frame: 1 year ]

Estimated Enrollment: 1000
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Nursing questionnaire:

  1. How many beds were appointed to you?

    1. 1
    2. 2
    3. 3
    4. 4
    5. 5
    6. 6
  2. For how many of such patients you could care for maximally?

    1. 1
    2. 2
    3. 3
    4. 4
    5. >4
  3. This patients' burden of care corresponds to:

    1. An intensive care patient who requires more than standard intensive care
    2. An intensive care patient who requires standard intensive care
    3. A medium care patient

medical staff and head nurse questionaire:

  1. For how many of such patients you could care for maximally?

    1. 1
    2. 2
    3. 3
    4. 4
    5. >4
  2. This patients' burden of care corresponds to?

    1. An intensive care patient who requires more than standard intensive care
    2. An intensive care patient who requires standard intensive care
    3. A medium care patient
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
acute patients
Criteria

Inclusion Criteria:

  • admission to one of the 9 critical area's
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633606


Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Greet Van den Berghe, MD PhD Catholic University Leuven
Principal Investigator: Karen Decock, RS Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: Greet Van den Berghe, professor, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01633606     History of Changes
Other Study ID Numbers: NAS-ICU-2012
First Submitted: July 2, 2012
First Posted: July 4, 2012
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Greet Van den Berghe, Katholieke Universiteit Leuven:
severity of illness
scoring
medium care
intensive care
staffing

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes