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

Primary Purpose

Varicose Ulcer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clients randomized to nurse-led clinic
Clients receive leg ulcer care in their homes
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Ulcer focused on measuring venous ulcer, leg ulcer, stasis ulcer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Carleton Community Care Access Centre
  • Victorian Order of Nurses, Ottawa-Carleton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Client is randomized to receive leg ulcer treatment in the home

Client randomized to receive leg ulcer care in the clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to complete healing, ulcer size, and ulcer recurrence over 12 months
Client function, pain and health-related quality of life
Client and provider satisfaction
Health services expenditure and utilization

Full Information

First Posted
April 7, 2008
Last Updated
November 18, 2015
Sponsor
Queen's University
Collaborators
The Ottawa Hospital, University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT00656383
Brief Title
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Official Title
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
The Ottawa Hospital, University of Ottawa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
Keywords
venous ulcer, leg ulcer, stasis ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Client is randomized to receive leg ulcer treatment in the home
Arm Title
2
Arm Type
Active Comparator
Arm Description
Client randomized to receive leg ulcer care in the clinic
Intervention Type
Other
Intervention Name(s)
Clients randomized to nurse-led clinic
Other Intervention Name(s)
Usual Care, Best Practice, Venous Leg Ulcer treatment
Intervention Description
Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
Intervention Type
Other
Intervention Name(s)
Clients receive leg ulcer care in their homes
Other Intervention Name(s)
Leg Ulcer Care, Usual Care, Best Practice
Intervention Description
Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
Primary Outcome Measure Information:
Title
Proportion in each study arm of ulcerated limbs completely healed at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to complete healing, ulcer size, and ulcer recurrence over 12 months
Time Frame
12 months
Title
Client function, pain and health-related quality of life
Time Frame
12 months
Title
Client and provider satisfaction
Time Frame
12 months
Title
Health services expenditure and utilization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret B Harrison, RN, PhD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian D Graham, PhD
Organizational Affiliation
Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philip S Wells, PhD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan VanDeVelde, PhD
Organizational Affiliation
Victorian Order of Nurses, Ottawa-Carleton Branch
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Judith L Threinen, BSR, MHA
Organizational Affiliation
Ottawa-Carleton Community Care Access Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donna I Nicholson, Dip O&A
Organizational Affiliation
Ottawa Carleton Community Care Access Centre
Official's Role
Study Director
Facility Information:
Facility Name
Ottawa Carleton Community Care Access Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1J 7T2
Country
Canada
Facility Name
Victorian Order of Nurses, Ottawa-Carleton
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K 3B8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19036149
Citation
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.
Results Reference
derived

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

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