Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
WIT
1 other identifier
interventional
451
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 25, 2013
October 1, 2013
2.1 years
May 4, 2011
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Healing
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
6 months
Secondary Outcomes (6)
proportion of wound healed
6 months
Wound recurrence
6 months
time to discontinuation of wound service
1 years
Health Related Quality of Life (HRQOL)
6 months
client satisfaction
6 months
- +1 more secondary outcomes
Study Arms (2)
Control Arm
NO INTERVENTIONUsual care is care as currently delivered to clients with chronic wounds in the community.
Intervention Arm
EXPERIMENTALSystematic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Surgical wounds
- Burns
- Malignant wounds
- Clients who are designated palliative on CCAC referral form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
THETA Collaborative
Toronto, Ontario, M5S 3M2, Canada
Related Publications (10)
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PMID: 21375959BACKGROUNDJeffcoate 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.
PMID: 19922726BACKGROUNDHawes 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.
PMID: 17565102BACKGROUNDFries 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.
PMID: 15498843BACKGROUNDTorrance 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.
PMID: 10155336BACKGROUNDWodchis 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.
PMID: 12962335BACKGROUNDWodchis 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.
PMID: 17419961BACKGROUNDBurrows 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.
PMID: 10791452BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Murray Krahn, PhD, MD
Director
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, THETA
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 5, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2013
Study Completion
October 1, 2013
Last Updated
October 25, 2013
Record last verified: 2013-10