Varicose UlcerNCT00656383
Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
A study testing Clients randomized to nurse-led clinic and Clients receive leg ulcer care in their homes in people with Varicose Ulcer, run by Queen's University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Clients randomized to nurse-led clinic and Clients receive leg ulcer care in their homes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2000to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Treatment is contraindicated
- The ulcer in question is not venous
- The client cannot travel outside the home or travel is impeded
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ottawa Carleton Community Care Access Centre
Ottawa, Ontario, K1J 7T2
Victorian Order of Nurses, Ottawa-Carleton
Ottawa, Ontario, K1K 3B8
About this study
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.
Read the 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.
- Conditions
- Varicose Ulcer
- Being tested
- Clients randomized to nurse-led clinic, Clients receive leg ulcer care in their homes
- Keywords
- venous ulcer, leg ulcer, stasis ulcer
- Medical subject headings
- Varicose Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clients randomized to nurse-led clinicOther
Also called Usual Care, Best Practice, Venous Leg Ulcer treatment
Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
Clients receive leg ulcer care in their homesOther
Also called Leg Ulcer Care, Usual Care, Best Practice
Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Client is randomized to receive leg ulcer treatment in the home Receives: Other: Clients receive leg ulcer care in their homes |
| 2 | Active comparator | Client randomized to receive leg ulcer care in the clinic Receives: Other: Clients randomized to nurse-led clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion in each study arm of ulcerated limbs completely healed at 3 months
Measured: 3 months
Secondary outcomes (4)
Time to complete healing, ulcer size, and ulcer recurrence over 12 months
Measured: 12 months
Client function, pain and health-related quality of life
Measured: 12 months
Client and provider satisfaction
Measured: 12 months
Health services expenditure and utilization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startOct 2000
- Primary completionMar 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa
- Responsible party
- Principal investigator, Dr. Margaret Harrison, Queen's University
- Investigators
- Margaret B Harrison, RN, PhD, Principal investigator, The Ottawa HospitalIan D Graham, PhD, Study director, Clinical Epidemiology Unit, Ottawa Hospital-Civic CampusPhilip S Wells, PhD, Study director, The Ottawa HospitalSusan VanDeVelde, PhD, Study director, Victorian Order of Nurses, Ottawa-Carleton BranchJudith L Threinen, BSR, MHA, Study director, Ottawa-Carleton Community Care Access CentreDonna I Nicholson, Dip O&A, Study director, Ottawa Carleton Community Care Access Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656383
- Sponsor's protocol ID
- MOP-42497
- Status last verified
- Nov 2015
- First submitted
- 7 Apr 2008
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19036149
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
- ClinicalTrials.gov ID
- NCT00656383
- Acronym / sponsor ID
- MOP-42497
- Conditions
- Varicose Ulcer
- Keywords
- venous ulcer, leg ulcer, stasis ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, University of Ottawa
- Study start
- Oct 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Clients receive leg ulcer care in their homesClient is randomized to receive leg ulcer treatment in the home |
| 2 | Active comparator | Other: Clients randomized to nurse-led clinicClient randomized to receive leg ulcer care in the clinic |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (3 listed)
- Treatment is contraindicated
- The ulcer in question is not venous
- The client cannot travel outside the home or travel is impeded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clients randomized to nurse-led clinicAlso: Usual Care, Best Practice, Venous Leg Ulcer treatmentClients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol | Other | 2 |
| Clients receive leg ulcer care in their homesAlso: Leg Ulcer Care, Usual Care, Best PracticeClients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol | Other | 1 |
Primary outcome
Proportion in each study arm of ulcerated limbs completely healed at 3 months
Time frame: 3 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 19036149Harrison 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.
Related trials for Varicose Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret B Harrison, RN, PhD principal investigator
The Ottawa Hospital
Ian D Graham, PhD study director
Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
Philip S Wells, PhD study director
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clients randomized to nurse-led clinic and Clients receive leg ulcer care in their homes in people with Varicose Ulcer, run by Queen's University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion in each study arm of ulcerated limbs completely healed at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.