Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- Proportion in each study arm of ulcerated limbs completely healed at 3 months
研究概览
简要总结
Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months. Secondary outcomes are: time to healing of all ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the number of weeks patients were free from ulcers, function, pain, and health related quality of life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics result in better healing rates, more cost-effective care, and improved client and provider satisfaction than the home visiting model.
详细描述
The management of chronic wounds in the community is a pressing issue for home care authorities. The care of leg ulcers represents a considerable expense to the health care system. It has been estimated that the care of venous leg ulcers alone consumes 1% of the national health care budgets of the UK and France. A one-month prevalence study in the Ottawa Carleton region (pop. 750,000) revealed that 126 Community Care Access Centre Clients (CCAC - the regional health care authority) received over 1500 home nursing visits. During the course of a year this represents more than $600,000 in home nursing visits for this condition in just one Ontario region. There is evidence supporting effective wound management but this is not necessarily what patients receive. As well, appropriate evidence-based, efficient, community-based care must be supported by ready access to specialized facilities. Research from other countries suggest that reorganization of services which includes nurse-run clinic care near to home, evidence-based protocols, and enhanced linkages with secondary and tertiary services may result in improvements in healing rates and reductions in expenditures. These international studies provide optimism that with reorganization of care within the Canadian context we can deliver community services for improved outcomes. However, only with a rigorous evaluation of the effectiveness and efficiency can we understand if such changes in the Canadian context are beneficial.
Objective:
To evaluate the effectiveness and efficiency of two models of service delivery: traditional single service delivery model (home visiting) compared to nurse-led community clinics.
Research Questions:
- What are the health outcomes (healing, function, plain and quality of life) for two models of care (nurse-run neighbourhood clinics vs. home care) for the population with leg ulcers?
- What are health services utilization and expenditures associated with the two models of care?
- What is client and provider satisfaction with the nurse-run neighbourhood clinics and home nursing care?
- What are the barriers and supports to implementing neighbourhood leg ulcer clinics?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The client:
- •Admission to home care for care of a venous leg ulcer (below the knee to the foot)
- •Ability to travel to clinic
- •No major contraindication for clinic care (eg not being able to leave an ill spouse, refusal, etc.)
排除标准
- •Treatment is contraindicated
- •The ulcer in question is not venous
- •The client cannot travel outside the home or travel is impeded
研究组 & 干预措施
1
Client is randomized to receive leg ulcer treatment in the home
干预措施: Clients receive leg ulcer care in their homes (Other)
2
Client randomized to receive leg ulcer care in the clinic
干预措施: Clients randomized to nurse-led clinic (Other)
结局指标
主要结局
Proportion in each study arm of ulcerated limbs completely healed at 3 months
时间窗: 3 months
次要结局
- Client function, pain and health-related quality of life(12 months)
- Health services expenditure and utilization(12 months)
- Time to complete healing, ulcer size, and ulcer recurrence over 12 months(12 months)
- Client and provider satisfaction(12 months)
研究者
Dr. Margaret Harrison
Principal Investigator
Queen's University