Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
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|ClinicalTrials.gov Identifier: NCT00656383|
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Varicose Ulcer||Other: Clients randomized to nurse-led clinic Other: Clients receive leg ulcer care in their homes||Not Applicable|
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.
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.
- 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||March 2005|
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
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
- Proportion in each study arm of ulcerated limbs completely healed at 3 months [ Time Frame: 3 months ]
- Time to complete healing, ulcer size, and ulcer recurrence over 12 months [ Time Frame: 12 months ]
- Client function, pain and health-related quality of life [ Time Frame: 12 months ]
- Client and provider satisfaction [ Time Frame: 12 months ]
- Health services expenditure and utilization [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656383
|Ottawa Carleton Community Care Access Centre|
|Ottawa, Ontario, Canada, K1J 7T2|
|Victorian Order of Nurses, Ottawa-Carleton|
|Ottawa, Ontario, Canada, K1K 3B8|
|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|