- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01348841
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial (WIT)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5S 3M2
- THETA Collaborative
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control Arm
Usual care is care as currently delivered to clients with chronic wounds in the community.
|
|
|
Experimentell: Intervention Arm
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. |
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Healing
Tidsram: 6 months
|
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
proportion of wound healed
Tidsram: 6 months
|
proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
|
6 months
|
|
Wound recurrence
Tidsram: 6 months
|
Wound recurrence within the study period.
|
6 months
|
|
time to discontinuation of wound service
Tidsram: 1 years
|
Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
|
1 years
|
|
Health Related Quality of Life (HRQOL)
Tidsram: 6 months
|
Health related quality of life.
|
6 months
|
|
client satisfaction
Tidsram: 6 months
|
Satisfaction with care.
|
6 months
|
|
cost and resource use
Tidsram: 6 months
|
cost and resource use of wound care provided
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Murray Krahn, PhD, MD, Director
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Torrance 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1093/geront/47.3.378.
- 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. doi: 10.1093/geront/44.5.680.
- 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. doi: 10.1017/s0266462303000424.
- 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. doi: 10.1016/j.jclinepi.2006.08.009. Epub 2007 Jan 18.
- 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. doi: 10.1093/ageing/29.2.165.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25973
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