Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

Wound of Skin Clinical Trial

— WIT  

Official title:

Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348841
• Other study ID #: 25973
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: October 24, 2013
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical 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). 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Surgical wounds

• Burns

• Malignant wounds

• Clients who are designated palliative on CCAC referral form

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Wound of Skin

Intervention

Other:
• Systematic referral to MDWCT and comprehensive primary care
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.

Locations

Country	Name	City	State
Canada	THETA Collaborative	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. — View Citation

Burrows 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. — View Citation

Fries 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. — View Citation

Hawes 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. — View Citation

Jeffcoate 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. — View Citation

Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):503-20. Review. — View Citation

Watson 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. — View Citation

Wodchis 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. — View Citation

Wodchis 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. Epub 2007 Jan 18. — View Citation

Xakellis GC, Frantz R. The cost of healing pressure ulcers across multiple health care settings. Adv Wound Care. 1996 Nov-Dec;9(6):18-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	proportion of wound healed	proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).	6 months	No
Secondary	Wound recurrence	Wound recurrence within the study period.	6 months	No
Secondary	time to discontinuation of wound service	Time to discontinuation of wound services within the CCAC and interdisciplinary teams.	1 years	No
Secondary	Health Related Quality of Life (HRQOL)	Health related quality of life.	6 months	No
Secondary	client satisfaction	Satisfaction with care.	6 months	No
Secondary	cost and resource use	cost and resource use of wound care provided	6 months	No

External Links

•   Medical Advisory Secretariat. Multidisciplinary Care Community-Based Care for Chronic Wound Management: An Evidence-Based Analysis Ontario Ministry of Health and Long-Term Care, 2009.
•   Ontario Health Technology Advisory Committee (OHTAC) Recommendation: Specialized Multidisciplinary Community-Based Care, 2009.