Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT01633606
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2012-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'most discriminative NAS cut off for identifying medium care patient versus intensive care patient', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severity of illness', 'scoring', 'medium care', 'intensive care', 'staffing'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main study question is: What is the most discriminative NAS cut off for medium care patient?\n\nEach nursing shift the NAS and TISS 28 scores will be calculated for each patient who is admitted to the 8 participating units.\n\nNurses 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.\n\nEach morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward.\n\nIn 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.\n\nSecondary study questions are:\n\n* Can NAS score based on one nursing shift predict the severity of care in the subsequent nursing shift?\n* Is there a difference in appreciation of severity of care between nurses, head nurses and medical staff?\n* Which variables influence the perception of severity of care?\n* How does NAS relate to TISS28, APACHE and NEMS?', 'detailedDescription': "Nursing questionnaire:\n\n1. How many beds were appointed to you?\n\n 1. 1\n 2. 2\n 3. 3\n 4. 4\n 5. 5\n 6. 6\n2. For how many of such patients you could care for maximally?\n\n 1. 1\n 2. 2\n 3. 3\n 4. 4\n 5. \\>4\n3. This patients' burden of care corresponds to:\n\n 1. An intensive care patient who requires more than standard intensive care\n 2. An intensive care patient who requires standard intensive care\n 3. A medium care patient\n\nmedical staff and head nurse questionaire:\n\n1. For how many of such patients you could care for maximally?\n\n 1. 1\n 2. 2\n 3. 3\n 4. 4\n 5. \\>4\n2. This patients' burden of care corresponds to?\n\n 1. An intensive care patient who requires more than standard intensive care\n 2. An intensive care patient who requires standard intensive care\n 3. A medium care patient"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'acute patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* admission to one of the 9 critical area's"}, 'identificationModule': {'nctId': 'NCT01633606', 'briefTitle': 'Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score', 'orgStudyIdInfo': {'id': 'NAS-ICU-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute patients', 'description': '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'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Greet Van den Berghe, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catholic University Leuven'}, {'name': 'Karen Decock, RS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Greet Van den Berghe', 'investigatorAffiliation': 'KU Leuven'}}}}