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

This study has been completed.
Sponsor:
Collaborators:
The Ottawa Hospital
University of Ottawa
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00656383
First received: April 7, 2008
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Varicose Ulcer
Other: Clients randomized to nurse-led clinic
Other: Clients receive leg ulcer care in their homes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Proportion in each study arm of ulcerated limbs completely healed at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to complete healing, ulcer size, and ulcer recurrence over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Client function, pain and health-related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Client and provider satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health services expenditure and utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 401
Study Start Date: October 2000
Study Completion Date: March 2005
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Client is randomized to receive leg ulcer treatment in the home
Other: 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
Other Names:
  • Leg Ulcer Care
  • Usual Care
  • Best Practice
Active Comparator: 2
Client randomized to receive leg ulcer care in the clinic
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
Other Names:
  • Usual Care
  • Best Practice
  • Venous Leg Ulcer treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656383

Locations
Canada, Ontario
Victorian Order of Nurses, Ottawa-Carleton
Ottawa, Ontario, Canada, K1K 3B8
Ottawa Carleton Community Care Access Centre
Ottawa, Ontario, Canada, K1J 7T2
Sponsors and Collaborators
Queen's University
The Ottawa Hospital
University of Ottawa
Investigators
Principal Investigator: Margaret B Harrison, RN, PhD The Ottawa Hospital
Study Director: Ian D Graham, PhD Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
Study Director: Philip S Wells, PhD The Ottawa Hospital
Study Director: Susan VanDeVelde, PhD Victorian Order of Nurses, Ottawa-Carleton Branch
Study Director: Judith L Threinen, BSR, MHA Ottawa-Carleton Community Care Access Centre
Study Director: Donna I Nicholson, Dip O&A Ottawa Carleton Community Care Access Centre
  More Information

No publications provided by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Margaret B. Harrison, Loeb Health Research Institute
ClinicalTrials.gov Identifier: NCT00656383     History of Changes
Other Study ID Numbers: MOP-42497
Study First Received: April 7, 2008
Last Updated: April 16, 2008
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
venous ulcer, leg ulcer, stasis ulcer

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014