Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT01796756
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Improvement in Handover of General Internal Medicine In-patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients the resident on-call did not receive information on that would have been useful', 'timeFrame': '5 months'}, {'measure': 'Frequency of patients transferred to the ICU', 'timeFrame': '5 months'}, {'measure': 'Frequency of patients referred to the Critical Care Outreach Team', 'timeFrame': '5 months'}, {'measure': 'Frequency of inappropriate code blue calls for patients with a "do not resuscitate" order', 'timeFrame': '5 months'}, {'measure': 'Aggregate length of stay of patients admitted to the Clinical Teaching Unit', 'timeFrame': '5 months'}, {'measure': 'Aggregate rate of death of patients admitted to the Clinical Teaching Unit', 'timeFrame': '5 months'}, {'measure': 'Resource Utilization for patients assessed by the resident on-call overnight', 'timeFrame': '5 months', 'description': 'Resource utilization will be defined by the ordering of: radiological imaging, blood work, electrocardiogram, blood transfusions, IV fluid administration, and antibiotics.'}], 'primaryOutcomes': [{'measure': 'Proportion of patients handed over to the on-call resident/Clinical Associate (CA)', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Handover', 'Handoff', 'Signout', 'Quality Improvement', 'General Internal Medicine'], 'conditions': ['Quality Improvement in Patient Handoff']}, 'referencesModule': {'references': [{'pmid': '29672526', 'type': 'DERIVED', 'citation': 'Tam P, Nijjar AP, Fok M, Little C, Shingina A, Bittman J, Raghavan R, Khan NA. Structured patient handoff on an internal medicine ward: A cluster randomized control trial. PLoS One. 2018 Apr 19;13(4):e0195216. doi: 10.1371/journal.pone.0195216. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Miscommunication during patient handover can jeopardize patient safety and is the focus of Quality Improvement initiatives by many organizations. It is widely recognized that such miscommunication is preventable using a number of strategies identified in the literature.\n\nCurrently, there is no formal handover process of General Internal Medicine in-patients, otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is a major patient safety concern. This project will implement a formal handover program and evaluate whether there are changes in resident satisfaction with handover, but more importantly, whether the investigators can improve patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents, medical students, and patients\n* Residents and medical students will be any rotating through General Internal Medicine at Vancouver General Hospital\n* Patients will be any admitted to General Internal Medicine and cared for during on-call hours (defined as 18:00 - 07:00)\n\nExclusion Criteria:\n\n* None for residents and medical students\n* Patients who are not being cared for during on-call hours (defined as 18:00 - 07:00)'}, 'identificationModule': {'nctId': 'NCT01796756', 'briefTitle': 'Quality Improvement in Handover of General Internal Medicine In-patients', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Quality Improvement in Handover of General Internal Medicine In-patients', 'orgStudyIdInfo': {'id': 'H11-03542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Handover program', 'description': 'Standardized handover program Dedicated place and time Template Face-to-face communication Evidence-based education session Feedback and audit', 'interventionNames': ['Other: Handover program']}, {'type': 'NO_INTERVENTION', 'label': 'Usual handover practice'}], 'interventions': [{'name': 'Handover program', 'type': 'OTHER', 'armGroupLabels': ['Handover program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Penny Tam, BSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vancouver General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Medical Protective Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}