Clinical trial NCT00656383: 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
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Ulcer
Keywords: venous ulcer, leg ulcer, stasis ulcer
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: University of Ottawa
First posted: 2008-04-11
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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

Primary outcomes:
measure: Proportion in each study arm of ulcerated limbs completely healed at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Time to complete healing, ulcer size, and ulcer recurrence over 12 months
timeFrame: 12 months
measure: Client function, pain and health-related quality of life
timeFrame: 12 months
measure: Client and provider satisfaction
timeFrame: 12 months
measure: Health services expenditure and utilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Carleton Community Care Access Centre
state: Ontario
city: Ottawa
country: Canada
facility: Victorian Order of Nurses, Ottawa-Carleton
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Margaret B Harrison, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
name: Ian D Graham, PhD
role: STUDY_DIRECTOR
affiliation: The Ottawa Hospital
name: Philip S Wells, PhD
role: STUDY_DIRECTOR
affiliation: Victorian Order of Nurses, Ottawa-Carleton Branch
name: Susan VanDeVelde, PhD
role: STUDY_DIRECTOR
affiliation: Ottawa-Carleton Community Care Access Centre
name: Judith L Threinen, BSR, MHA
role: STUDY_DIRECTOR
affiliation: Ottawa Carleton Community Care Access Centre
name: Donna I Nicholson, Dip O&A
role: STUDY_DIRECTOR
References:
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.