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

Sponsor
Queen's University (Other)
Overall Status
Completed
CT.gov ID
NCT00656383
Collaborator
The Ottawa Hospital (Other), University of Ottawa (Other)
401
Enrollment
2
Locations
2
Arms
53
Duration (Months)
200.5
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clients randomized to nurse-led clinic
  • Other: Clients receive leg ulcer care in their homes
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
401 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Mar 1, 2004
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion in each study arm of ulcerated limbs completely healed at 3 months [3 months]

    Secondary Outcome Measures

    1. Time to complete healing, ulcer size, and ulcer recurrence over 12 months [12 months]

    2. Client function, pain and health-related quality of life [12 months]

    3. Client and provider satisfaction [12 months]

    4. Health services expenditure and utilization [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ottawa Carleton Community Care Access Centre Ottawa Ontario Canada K1J 7T2
    2 Victorian Order of Nurses, Ottawa-Carleton Ottawa Ontario Canada K1K 3B8

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Margaret Harrison, Principal Investigator, Queen's University
    ClinicalTrials.gov Identifier:
    NCT00656383
    Other Study ID Numbers:
    • MOP-42497
    First Posted:
    Apr 11, 2008
    Last Update Posted:
    Nov 20, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Dr. Margaret Harrison, Principal Investigator, Queen's University
    venous ulcer, leg ulcer, stasis ulcer
    Additional relevant MeSH terms:
    Varicose Ulcer

    Study Results

    No Results Posted as of Nov 20, 2015