Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-31 @ 3:35 AM
Study NCT ID:
NCT00614003
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2008-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Intervention Designed to Enhance the Quality of Decision Support Provided to Patients Making Decisions About End-of-life Place of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2008-01-18', 'studyFirstSubmitQcDate': '2008-01-30', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Knowledge of place of care determinants and decision support concepts; self perceived quality of decision support provision in clinical practice and behavior intention survey; acceptability and utility of intervention components', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['decisional conflict;', 'decision quality;', 'place of end of life care;', 'provider education'], 'conditions': ['Palliative Care']}, 'referencesModule': {'references': [{'pmid': '18447916', 'type': 'DERIVED', 'citation': "Murray MA, O'Connor A, Stacey D, Wilson KG. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol. BMC Palliat Care. 2008 Apr 30;7:4. doi: 10.1186/1472-684X-7-4."}]}, 'descriptionModule': {'briefSummary': 'Most dying cancer patients would prefer a home death yet die in an institution. Patients can experience uncertainty when weighing practical considerations, concern for others, and their personal ratings about the desirability and undesirability of various outcomes related to different locations of care. Health professionals, trained in decision support, can help patients to make decisions that are informed by both relevant information and what outcomes are most valued by patients. Therefore, I will study if an educational intervention can help nurses and case managers to strengthen their skills and confidence in providing patient decision support around place of end of life care.\n\nProject Description:\n\nUsing a two step approach I will study if the quality of providers decision support can be improved with an education. In step one nurses and care coordinators will be interviewed to identify factors that make it easier or more difficult to provide patient decision support. This information will be used to develop an education program. In step two, nurses and care coordinator volunteers will be assigned by a flip of a coin to either receive the decision support education or not. Before and after the education program the quality of the decision support participants provide will be measured and compared. As well, participants receiving the education program will be asked about their satisfaction with the education program.', 'detailedDescription': "Most terminal cancer patients prefer home palliation yet die in an institution. Some experience decisional conflict when weighing options regarding place of care. Community Case Managers and Nurses are well positioned to identify decisional needs and provide decision support; however, they generally lack skills and confidence in doing so. This study aims to determine whether the quality of case managers' and nurses' decision support can be improved with a theory-based skills-building intervention.\n\nIn phase one a needs assessment will be conducted with about 20 key informants. In phase two, nurses will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, is comprised of: an auto-tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach.\n\nParticipants will be assessed: a) at baseline (quality of decision support); b) after the auto-tutorial (knowledge); and six to eight weeks after the other interventions (quality of decision support; confidence and intention to integrate decision support into practice). Between group differences in the primary outcome (quality of decision support scores) will be analyzed using a repeated measures ANOVA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNurses and case coordinators who:\n\n* are members of a regulated health profession\n* care for palliative cancer patients, and/or\n* cancer patients with advanced disease, and\n* work at least 4 shifts per month,\n* in a clinical area where end of life care discussions are likely to be undertaken, and\n* are proficient in written and spoken English.'}, 'identificationModule': {'nctId': 'NCT00614003', 'briefTitle': 'Evaluation of an Intervention Designed to Enhance the Quality of Decision Support Provided to Patients Making Decisions About End-of-life Place of Care', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': "Efficacy of a Training Intervention on the Quality of Case Coordinators and Nurses' Decision Support for Patients Deciding About the Place of Care at the End Of-Life: A Randomized Control Trial", 'orgStudyIdInfo': {'id': 'H-01-07-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'decision support', 'interventionNames': ['Behavioral: Decision support skills building Intervention']}], 'interventions': [{'name': 'Decision support skills building Intervention', 'type': 'BEHAVIORAL', 'description': 'Decision support skills', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'St. Elizabeths Health Care Agency', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Carefor Nursing Services', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SCOHS Regional Palliative Care Community Services', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Community Care Access Center's (CCAC)", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': "Annette O'Connor, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}