Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
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| First Received Date ICMJE | May 4, 2011 | ||||||||
| Last Updated Date | May 10, 2013 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Time to Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ] The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement. |
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| Original Primary Outcome Measures ICMJE |
Time to Healing [ Time Frame: 2 years ] [ Designated as safety issue: No ] The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement. |
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| Change History | Complete list of historical versions of study NCT01348841 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial | ||||||||
| Official Title ICMJE | Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial | ||||||||
| Brief Summary | Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). One or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. Community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds. This study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. In this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed. |
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| Detailed Description | For certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. Wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. Systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. Therefore, the Ontario Health Technology Advisory Committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Wound of Skin | ||||||||
| Intervention ICMJE | Other: Systematic referral to MDWCT and comprehensive primary care
Systematic referral to, and follow up, by Multi-Disciplinary Wound Care Teams (MDWCTs), co-ordinated by the Case Manager (CM), will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4.
Other Name: systematic expedited referral to MDWCTs |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 450 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01348841 | ||||||||
| Other Study ID Numbers ICMJE | 25973 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Murray Krahn, University of Toronto | ||||||||
| Study Sponsor ICMJE | University of Toronto | ||||||||
| Collaborators ICMJE | Ontario Ministry of Health and Long Term Care | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Toronto | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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