Wound of SkinWITNCT01348841
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
A study testing Systematic referral to MDWCT and comprehensive primary care in people with Wound of Skin, run by University of Toronto at 1 site in Canada.
Trial summary
Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- Systematic referral to MDWCT and comprehensive primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Oct 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the Toronto Central CCAC for wound management.
- Client (or substitute decision maker) provides written, informed consent.
- Someone in client's home (or substitute decision maker) must be able to speak English.
Who cannot join
- Surgical wounds
- Burns
- Malignant wounds
- Clients who are designated palliative on CCAC referral form
Trial locations and contacts
1 site in 1 country.
About this study
Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). One or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. Community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds.
This study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. In this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed.
Read the detailed description
For certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. Wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. Systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. Therefore, the Ontario Health Technology Advisory Committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital
- Conditions
- Wound of Skin
- Being tested
- Systematic referral to MDWCT and comprehensive primary care
- Keywords
- community wound care, systematic wound team referral, Advanced in-home nurse wound training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic referral to MDWCT and comprehensive primary careOther
Also called systematic expedited referral to MDWCTs
Systematic referral to, and follow up, by Multi-Disciplinary Wound Care Teams (MDWCTs), co-ordinated by the Case Manager (CM), will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Usual care is care as currently delivered to clients with chronic wounds in the community. |
| Intervention Arm | Experimental | Systematic referral to MDWCT and comprehensive primary care:
Intervention consists of systematic referral to MDWCT in conjunction with comprehensive primary care.Systematic referral to, and follow up, by MDWCTs, co-ordinated by the CM, will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4. Receives: Other: Systematic referral to MDWCT and comprehensive primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Healing
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
Measured: 6 months
Secondary outcomes (6)
proportion of wound healed
proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
Measured: 6 months
Wound recurrence
Wound recurrence within the study period.
Measured: 6 months
time to discontinuation of wound service
Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
Measured: 1 years
Health Related Quality of Life (HRQOL)
Health related quality of life.
Measured: 6 months
client satisfaction
Satisfaction with care.
Measured: 6 months
cost and resource use
cost and resource use of wound care provided
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Wound of SkinStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Murray Krahn, University of Toronto
- Investigators
- Murray Krahn, PhD, MD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348841
- Sponsor's protocol ID
- 25973
- Acronym
- WIT
- Status last verified
- Oct 2013
- First submitted
- 4 May 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.
PubMed 15082426Xakellis GC, Frantz R. The cost of healing pressure ulcers across multiple health care settings. Adv Wound Care. 1996 Nov-Dec;9(6):18-22.
PubMed 9069752Watson JM, Kang'ombe AR, Soares MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson D, Nelson EA; VenUS III team. VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers. Health Technol Assess. 2011 Mar;15(13):1-192. doi: 10.3310/hta15130.
PubMed 21375959Jeffcoate WJ, Price PE, Phillips CJ, Game FL, Mudge E, Davies S, Amery CM, Edmonds ME, Gibby OM, Johnson AB, Jones GR, Masson E, Patmore JE, Price D, Rayman G, Harding KG. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess. 2009 Nov;13(54):1-86, iii-iv. doi: 10.3310/hta13540.
PubMed 19922726Hawes C, Fries BE, James ML, Guihan M. Prospects and pitfalls: use of the RAI-HC assessment by the Department of Veterans Affairs for home care clients. Gerontologist. 2007 Jun;47(3):378-87. doi: 10.1093/geront/47.3.378.
PubMed 17565102Fries BE, James M, Hammer SS, Shugarman LR, Morris JN. Is telephone screening feasible? Accuracy and cost-effectiveness of identifying people medically eligible for home- and community-based services. Gerontologist. 2004 Oct;44(5):680-8. doi: 10.1093/geront/44.5.680.
PubMed 15498843Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):503-20. doi: 10.2165/00019053-199507060-00005.
PubMed 10155336Wodchis WP, Hirdes JP, Feeny DH. Health-related quality of life measure based on the minimum data set. Int J Technol Assess Health Care. 2003 Summer;19(3):490-506. doi: 10.1017/s0266462303000424.
PubMed 12962335Wodchis WP, Maxwell CJ, Venturini A, Walker JD, Zhang J, Hogan DB, Feeny DF. Study of observed and self-reported HRQL in older frail adults found group-level congruence and individual-level differences. J Clin Epidemiol. 2007 May;60(5):502-11. doi: 10.1016/j.jclinepi.2006.08.009. Epub 2007 Jan 18.
PubMed 17419961Burrows AB, Morris JN, Simon SE, Hirdes JP, Phillips C. Development of a minimum data set-based depression rating scale for use in nursing homes. Age Ageing. 2000 Mar;29(2):165-72. doi: 10.1093/ageing/29.2.165.
PubMed 10791452
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01348841
- Acronym / sponsor ID
- WIT / 25973
- Conditions
- Wound of Skin
- Keywords
- community wound care, systematic wound team referral, Advanced in-home nurse wound training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 May 2011 (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.
Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). One or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. Community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds.
This study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. In this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed.
Detailed description
For certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. Wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. Systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. Therefore, the Ontario Health Technology Advisory Committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Usual care is care as currently delivered to clients with chronic wounds in the community. |
| Intervention Arm | Experimental | Other: Systematic referral to MDWCT and comprehensive primary careSystematic referral to MDWCT and comprehensive primary care: Intervention consists of systematic referral to MDWCT in conjunction with comprehensive primary care.Systematic referral to, and follow up, by MDWCTs, co-ordinated by the CM, will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the Toronto Central CCAC for wound management.
- Client (or substitute decision maker) provides written, informed consent.
- Someone in client's home (or substitute decision maker) must be able to speak English.
Key exclusion criteria (4 listed)
- Surgical wounds
- Burns
- Malignant wounds
- Clients who are designated palliative on CCAC referral form
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 |
|---|---|---|
| Systematic referral to MDWCT and comprehensive primary careAlso: systematic expedited referral to MDWCTsSystematic referral to, and follow up, by Multi-Disciplinary Wound Care Teams (MDWCTs), co-ordinated by the Case Manager (CM), will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4. | Other | Intervention Arm |
Primary outcome
Time to Healing
Time frame: 6 months
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
6 secondary outcomes
proportion of wound healed
Time frame: 6 months
Wound recurrence
Time frame: 6 months
time to discontinuation of wound service
Time frame: 1 years
Health Related Quality of Life (HRQOL)
Time frame: 6 months
client satisfaction
Time frame: 6 months
cost and resource use
Time frame: 6 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 25 Oct 2013.
- Background: PubMed 15082426Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.
- Background: PubMed 9069752Xakellis GC, Frantz R. The cost of healing pressure ulcers across multiple health care settings. Adv Wound Care. 1996 Nov-Dec;9(6):18-22.
- Background: PubMed 21375959Watson JM, Kang'ombe AR, Soares MO, Chuang LH, Worthy G, Bland JM, Iglesias C, Cullum N, Torgerson D, Nelson EA; VenUS III team. VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers. Health Technol Assess. 2011 Mar;15(13):1-192. doi: 10.3310/hta15130.
- Background: PubMed 19922726Jeffcoate WJ, Price PE, Phillips CJ, Game FL, Mudge E, Davies S, Amery CM, Edmonds ME, Gibby OM, Johnson AB, Jones GR, Masson E, Patmore JE, Price D, Rayman G, Harding KG. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technol Assess. 2009 Nov;13(54):1-86, iii-iv. doi: 10.3310/hta13540.
- Background: PubMed 17565102Hawes C, Fries BE, James ML, Guihan M. Prospects and pitfalls: use of the RAI-HC assessment by the Department of Veterans Affairs for home care clients. Gerontologist. 2007 Jun;47(3):378-87. doi: 10.1093/geront/47.3.378.
- Background: PubMed 15498843Fries BE, James M, Hammer SS, Shugarman LR, Morris JN. Is telephone screening feasible? Accuracy and cost-effectiveness of identifying people medically eligible for home- and community-based services. Gerontologist. 2004 Oct;44(5):680-8. doi: 10.1093/geront/44.5.680.
- Background: PubMed 10155336Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):503-20. doi: 10.2165/00019053-199507060-00005.
- Background: PubMed 12962335Wodchis WP, Hirdes JP, Feeny DH. Health-related quality of life measure based on the minimum data set. Int J Technol Assess Health Care. 2003 Summer;19(3):490-506. doi: 10.1017/s0266462303000424.
- Background: PubMed 17419961Wodchis WP, Maxwell CJ, Venturini A, Walker JD, Zhang J, Hogan DB, Feeny DF. Study of observed and self-reported HRQL in older frail adults found group-level congruence and individual-level differences. J Clin Epidemiol. 2007 May;60(5):502-11. doi: 10.1016/j.jclinepi.2006.08.009. Epub 2007 Jan 18.
- Background: PubMed 10791452Burrows AB, Morris JN, Simon SE, Hirdes JP, Phillips C. Development of a minimum data set-based depression rating scale for use in nursing homes. Age Ageing. 2000 Mar;29(2):165-72. doi: 10.1093/ageing/29.2.165.
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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.
Murray Krahn, PhD, MD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic referral to MDWCT and comprehensive primary care in people with Wound of Skin, run by University of Toronto at 1 site 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 3 inclusion and 4 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 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to Healing (time frame: 6 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 NCT01348841, which also lists 10 linked publications.
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 25 Oct 2013.