跳至主要内容
临床试验/NCT01348841
NCT01348841已完成不适用

Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

University of Toronto1 个研究点 分布在 1 个国家目标入组 451 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
451
试验地点
1
主要终点
Time to Healing

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult (>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the Toronto Central CCAC for wound management.
  • •Client (or substitute decision maker) provides written, informed consent.
  • •Someone in client's home (or substitute decision maker) must be able to speak English.

排除标准

  • •Surgical wounds
  • •Malignant wounds
  • •Clients who are designated palliative on CCAC referral form

研究组 & 干预措施

Control Arm

No Intervention

Usual care is care as currently delivered to clients with chronic wounds in the community.

Intervention Arm

Experimental

Systematic referral to MDWCT and comprehensive primary care:

Intervention consists of systematic referral to MDWCT in conjunction with comprehensive primary care.Systematic referral to, and follow up, by MDWCTs, co-ordinated by the 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.

干预措施: Systematic referral to MDWCT and comprehensive primary care (Other)

结局指标

主要结局

Time to Healing

时间窗: 6 months

The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.

次要结局

  • Wound recurrence(6 months)
  • Health Related Quality of Life (HRQOL)(6 months)
  • cost and resource use(6 months)
  • proportion of wound healed(6 months)
  • time to discontinuation of wound service(1 years)
  • client satisfaction(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murray Krahn

Director, THETA

University of Toronto

研究点 (1)

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