Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Condition: Varicose Ulcer
MeSH terms: Varicose Ulcer
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Clients randomized to nurse-led clinic; Clients receive leg ulcer care in their homes
Intervention type(s): Other; Other
Intervention description(s): Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol; Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
Other intervention name(s): Usual Care; Best Practice; Venous Leg Ulcer treatment; Leg Ulcer Care; Usual Care; Best Practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: venous ulcer, leg ulcer, stasis ulcer