Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-04 @ 3:22 PM
Study NCT ID:
NCT01960556
Status:
COMPLETED
Last Update Posted:
2013-10-10
First Post:
2013-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation-Based Central Venous Line Maintenance Bundle Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CVL scores', 'timeFrame': '12 months', 'description': 'Change in CVL scores with and without simulation based education'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['simulation'], 'conditions': ['Central Line Infection']}, 'referencesModule': {'references': [{'pmid': '25468293', 'type': 'DERIVED', 'citation': 'Hebbar KB, Cunningham C, McCracken C, Kamat P, Fortenberry JD. Simulation-based paediatric intensive care unit central venous line maintenance bundle training. Intensive Crit Care Nurs. 2015 Feb;31(1):44-50. doi: 10.1016/j.iccn.2014.10.003. Epub 2014 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity and mortality in adult and pediatric critical care units. While it has been established that CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training and retention of proper bundle compliance remains a challenge.\n\nThe investigators prospectively compared this simulation-based program to a standard educational approach.\n\nThe investigators hypothesized that implementation of bedside simulation-based training of CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.', 'detailedDescription': 'The 2006 NACHRI Quality Transformation Effort demonstrated that additional reduction in pediatric catheter associated blood stream infection (CA-BSI) rates could be achieved through improving compliance with maintenance bundle care for central lines. The investigators objective was to improve maintenance bundle compliance rates and nursing competency surrounding central venous line (CVL) care in their pediatric intensive care unit (PICU).\n\nA multidisciplinary team developed a bedside simulation-based training program to improve compliance with standard PICU CVL maintenance bundle. The investigators then performed a randomized comparison study comparing a standard CVL bundle education process for bedside PICU nurses in a control group (CG) to an intervention group (IG) receiving bedside training to simulate a CVL dressing change and maintenance bundle followed by intermittent educational refresh. Groups were assessed for compliance with prescribed components of the CVL bundle maintenance (CVL score).\n\nCVL scores will be compared between groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric ICU nurses', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any nurse assigned to the PICU on a regular basis was eligible to participate in the study, including full-time, part-time, and occasional (prn) PICU nursing staff, as well as central staffing office (ICU float nurses) and traveler nurses contracted to the PICU for a minimum of 12 weeks\n\nExclusion Criteria:\n\n* Nurses floating from other units, agency nursing personnel, or traveler nurse contract of \\< 12 week period were excluded. Nurses on orientation were excluded until completion of introductory 6-month probation period'}, 'identificationModule': {'nctId': 'NCT01960556', 'acronym': 'CA-BSI', 'briefTitle': 'Simulation-Based Central Venous Line Maintenance Bundle Education', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Simulation-Based Pediatric Intensive Care Unit Central Venous Line Maintenance Bundle Education', 'orgStudyIdInfo': {'id': 'CA-BSI and Simulation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Simulation', 'description': 'Simulation Training part of education', 'interventionNames': ['Other: Simulation Training']}, {'label': 'Non-Simulation Based Education', 'description': 'Did not receive simulation based education'}], 'interventions': [{'name': 'Simulation Training', 'type': 'OTHER', 'otherNames': ['Education'], 'description': 'Simulation training provided to one group', 'armGroupLabels': ['Simulation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kiran B Hebbar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Pediatric Simulation Center', 'investigatorFullName': 'Kiran Hebbar', 'investigatorAffiliation': "Children's Healthcare of Atlanta"}}}}