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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 is not yet open for participant recruitment.
Verified February 2013 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01633606
First received: July 2, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  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 Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • most discriminative NAS cut off for identifying medium care patient versus intensive care patient [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633606

Contacts
Contact: Karen Decock, NRS 003216344065 karen.decock@uzleuven.be
Contact: Michael Casaer, MD 003216348786 michael.casaer@hotmail.com

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

No publications provided

Responsible Party: Greet Van den Berghe, professor, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01633606     History of Changes
Other Study ID Numbers: NAS-ICU-2012
Study First Received: July 2, 2012
Last Updated: February 14, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:
severity of illness
scoring
medium care
intensive care
staffing

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013