Skip to main content
OpenTrials
Completed

NCT Number: NCT00656383

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Carleton Community Care Access Centre, Ottawa, Ontario, Canada

Loading trial locations.

About this study

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?

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.)

Exclusion criteria

  • Treatment is contraindicated
  • The ulcer in question is not venous
  • The client cannot travel outside the home or travel is impeded

Treatment and study plan

Clients randomized to nurse-led clinic

Other

Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol

Other names: Usual Care, Best Practice, Venous Leg Ulcer treatment

Clients receive leg ulcer care in their homes

Other

Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol

Other names: Leg Ulcer Care, Usual Care, Best Practice

Primary outcomes

  1. Proportion in each study arm of ulcerated limbs completely healed at 3 months

    Time frame: 3 months

Secondary outcomes

  1. Time to complete healing, ulcer size, and ulcer recurrence over 12 months

    Time frame: 12 months

  2. Client function, pain and health-related quality of life

    Time frame: 12 months

  3. Client and provider satisfaction

    Time frame: 12 months

  4. Health services expenditure and utilization

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • The Ottawa Hospital
  • University of Ottawa

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2005
First posted
Apr 11, 2008
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.