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Completed

NCT Number: NCT01348841

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

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.

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Key information

Conditions

Wound of Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

THETA Collaborative

Toronto, Ontario, M5S 3M2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic referral to MDWCT and comprehensive primary care

Other

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.

Other names: systematic expedited referral to MDWCTs

Primary outcomes

  1. Time to Healing

    Time frame: 6 months

    The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.

Secondary outcomes

  1. proportion of wound healed

    Time frame: 6 months

    proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).

  2. Wound recurrence

    Time frame: 6 months

    Wound recurrence within the study period.

  3. time to discontinuation of wound service

    Time frame: 1 years

    Time to discontinuation of wound services within the CCAC and interdisciplinary teams.

  4. Health Related Quality of Life (HRQOL)

    Time frame: 6 months

    Health related quality of life.

  5. client satisfaction

    Time frame: 6 months

    Satisfaction with care.

  6. cost and resource use

    Time frame: 6 months

    cost and resource use of wound care provided

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Acronym: WIT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 5, 2011
Registry last updated
Oct 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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