Varicose Ulcer Clinical Trial
Official title:
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
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.
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:
1. 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?
2. What are health services utilization and expenditures associated with the two models of
care?
3. What is client and provider satisfaction with the nurse-run neighbourhood clinics and
home nursing care?
4. What are the barriers and supports to implementing neighbourhood leg ulcer clinics?
Study Design and Method:
A randomized health services controlled trial of nurse-run neighbourhood leg ulcer clinics
(intervention) and home care (current practice) with a cost-effectiveness analysis. A
repeated measures design will be used to assess healing and ulcer improvement, quality of
life and patient satisfaction over time.
Outcome measures:
The primary outcome measure is the proportion of limbs healed by three months. Secondary
outcome measures are: time to complete healing, ulcer size, ulcer recurrence, function,
pain, quality of life, client and provider satisfaction.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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