Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

Varicose Ulcer Clinical Trial

Official title:

Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656383
• Other study ID #: MOP-42497
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: November 18, 2015
• Start date: October 2000
• Est. completion date: March 2005

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: March 2005
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Ulcer

Intervention

Other:
• Clients randomized to nurse-led clinic
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 their homes
Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol

Locations

Country	Name	City	State
Canada	Ottawa Carleton Community Care Access Centre	Ottawa	Ontario
Canada	Victorian Order of Nurses, Ottawa-Carleton	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	The Ottawa Hospital, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion in each study arm of ulcerated limbs completely healed at 3 months		3 months	No
Secondary	Time to complete healing, ulcer size, and ulcer recurrence over 12 months		12 months	No
Secondary	Client function, pain and health-related quality of life		12 months	No
Secondary	Client and provider satisfaction		12 months	No
Secondary	Health services expenditure and utilization		12 months	No