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| Name | Class |
|---|---|
| The Ottawa Hospital | OTHER |
| University of Ottawa | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Client is randomized to receive leg ulcer treatment in the home |
|
| 2 | Active Comparator | Client randomized to receive leg ulcer care in the clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion in each study arm of ulcerated limbs completely healed at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete healing, ulcer size, and ulcer recurrence over 12 months | 12 months | |
| Client function, pain and health-related quality of life | 12 months | |
| Client and provider satisfaction |
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Inclusion Criteria:
The client:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret B Harrison, RN, PhD | The Ottawa Hospital | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Carleton Community Care Access Centre | Ottawa | Ontario | K1J 7T2 | Canada | ||
| Victorian Order of Nurses, Ottawa-Carleton |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19036149 | Derived | Harrison MB, Graham ID, Lorimer K, Vandenkerkhof E, Buchanan M, Wells PS, Brandys T, Pierscianowski T. Nurse clinic versus home delivery of evidence-based community leg ulcer care: a randomized health services trial. BMC Health Serv Res. 2008 Nov 26;8:243. doi: 10.1186/1472-6963-8-243. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| 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 |
|
|
| 12 months |
| Health services expenditure and utilization | 12 months |
| Ottawa |
| Ontario |
| K1K 3B8 |
| Canada |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |