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

24. oktober 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

451

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3M2
        • THETA Collaborative

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control Arm
Usual care is care as currently delivered to clients with chronic wounds in the community.
Eksperimentell: 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.
Annen: 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.
Andre navn:
  • systematic expedited referral to MDWCTs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Healing
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
proportion of wound healed
Tidsramme: 6 months
proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
6 months
Wound recurrence
Tidsramme: 6 months
Wound recurrence within the study period.
6 months
time to discontinuation of wound service
Tidsramme: 1 years
Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
1 years
Health Related Quality of Life (HRQOL)
Tidsramme: 6 months
Health related quality of life.
6 months
client satisfaction
Tidsramme: 6 months
Satisfaction with care.
6 months
cost and resource use
Tidsramme: 6 months
cost and resource use of wound care provided
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Toronto

Samarbeidspartnere

Ontario Ministry of Health and Long Term Care

Etterforskere

  • Hovedetterforsker: Murray Krahn, PhD, MD, Director

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Primær fullføring (Faktiske)

1. juni 2013

Studiet fullført (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først innsendt

4. mai 2011

Først innsendt som oppfylte QC-kriteriene

4. mai 2011

Først lagt ut (Anslag)

5. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2013

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25973

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