Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-02 @ 2:31 AM
Study NCT ID:
NCT01573832
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Client Care Project Trial: Wound Care Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13999}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2012-01-13', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients whose wound heals within the outcomes benchmark', 'timeFrame': '1 year', 'description': 'percentage of patients whose wound heals within the outcomes benchmark'}], 'secondaryOutcomes': [{'measure': 'time to wound healing outcomes', 'timeFrame': '1 year', 'description': 'time to wound healing outcomes'}, {'measure': 'total patient length of stay', 'timeFrame': 'at patient discharge, up to 365 days', 'description': 'total patient length of stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound']}, 'referencesModule': {'references': [{'pmid': '28851413', 'type': 'DERIVED', 'citation': 'Zwarenstein M, Shariff S, Mittmann N, Stern A, Dainty KN. A large cluster randomized trial of outcome-based pathways to improve home-based wound care. Trials. 2017 Aug 29;18(1):393. doi: 10.1186/s13063-017-2082-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will use a randomized control trial design to compare wound care clients who receive "integrated care" versus "usual care" in Community Care Access Centres (CCAC) in Ontario. Data will be collected by existing administrative databases and linked by the Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these databases and report findings.', 'detailedDescription': 'The researchers are interested in finding out whether the intervention ("integrated care") helps to improve patient outcomes. A randomized control trial of wound care clients in Ontario CCACs will show the effects of the intervention (integrated care) versus "usual care" clients. The researchers will also examine the financial system costs associated with providing "integrated care" to clients versus "usual care".\n\nThe researchers expect to answer the research question of whether there is difference in patient outcomes between "integrated care" versus "usual care clients." The researchers also would like to formulate a response for whether there will be financial system cost difference between "integrated care" and "usual care" clients.\n\nThe goal of this evaluation is to help decision-makers in the Ministry of Health and Long Term Care (MOHLTC), in the Community Care Access Centres (CCACs) and among provider organizations to improve the quality of care and patient outcomes for wound care clients, by evaluating innovations in the delivery of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receives wound care from Community Care Access Centre provider\n* adults over age 18 in Ontario\n\nExclusion Criteria:\n\n* patients who do not receive wound care from Ontario Community Care Access Centres'}, 'identificationModule': {'nctId': 'NCT01573832', 'acronym': 'ICCP-WC', 'briefTitle': 'Integrated Client Care Project Trial: Wound Care Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Integrated Client Care Project Randomized Control Trial: Wound Care Evaluation', 'orgStudyIdInfo': {'id': '11-289c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetic Foot Ulcer Intervention', 'interventionNames': ['Other: integrated client care group']}, {'type': 'NO_INTERVENTION', 'label': 'Diabetic Foot Ulcer Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'Pionidal Sinus Ulcer Intervention', 'interventionNames': ['Other: integrated client care group']}, {'type': 'NO_INTERVENTION', 'label': 'Pionidal Sinus Ulcer Usual Care'}], 'interventions': [{'name': 'integrated client care group', 'type': 'OTHER', 'description': 'receives integrated client care for wound treatment', 'armGroupLabels': ['Diabetic Foot Ulcer Intervention', 'Pionidal Sinus Ulcer Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Merrick F Zwarenstein, MB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sunnybrook and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}