NCT01633606

Brief 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. 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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

July 2, 2012

Last Update Submit

January 28, 2014

Conditions

Keywords

severity of illnessscoringmedium careintensive carestaffing

Outcome Measures

Primary Outcomes (1)

  • most discriminative NAS cut off for identifying medium care patient versus intensive care patient

    1 year

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

acute patients

You may qualify if:

  • admission to one of the 9 critical area's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Greet Van den Berghe, MD PhD

    Catholic University Leuven

    STUDY DIRECTOR
  • Karen Decock, RS

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 4, 2012

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01