Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial (WIT)
24 octobre 2013 mis à jour par: Murray Krahn, University of Toronto
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Réel)
451
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Ontario
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Toronto, Ontario, Canada, M5S 3M2
- THETA Collaborative
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Arm
Usual care is care as currently delivered to clients with chronic wounds in the community.
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|
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time to Healing
Délai: 6 months
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The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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proportion of wound healed
Délai: 6 months
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proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
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6 months
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Wound recurrence
Délai: 6 months
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Wound recurrence within the study period.
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6 months
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time to discontinuation of wound service
Délai: 1 years
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Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
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1 years
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Health Related Quality of Life (HRQOL)
Délai: 6 months
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Health related quality of life.
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6 months
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client satisfaction
Délai: 6 months
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Satisfaction with care.
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6 months
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cost and resource use
Délai: 6 months
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cost and resource use of wound care provided
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Murray Krahn, PhD, MD, Director
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 juin 2013
Achèvement de l'étude (Réel)
1 octobre 2013
Dates d'inscription aux études
Première soumission
4 mai 2011
Première soumission répondant aux critères de contrôle qualité
4 mai 2011
Première publication (Estimation)
5 mai 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 octobre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 octobre 2013
Dernière vérification
1 octobre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25973
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