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

Sponsor
University of Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01348841
Collaborator
Ontario Ministry of Health and Long Term Care (Other)
451
1
2
29
15.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Systematic referral to MDWCT and comprehensive primary care
N/A

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
451 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Arm

Usual care is care as currently delivered to clients with chronic wounds in the community.

Experimental: 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.

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.
Other Names:
  • systematic expedited referral to MDWCTs
  • Outcome Measures

    Primary Outcome Measures

    1. Time to Healing [6 months]

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

    Secondary Outcome Measures

    1. proportion of wound healed [6 months]

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

    2. Wound recurrence [6 months]

      Wound recurrence within the study period.

    3. time to discontinuation of wound service [1 years]

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

    4. Health Related Quality of Life (HRQOL) [6 months]

      Health related quality of life.

    5. client satisfaction [6 months]

      Satisfaction with care.

    6. cost and resource use [6 months]

      cost and resource use of wound care provided

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 THETA Collaborative Toronto Ontario Canada M5S 3M2

    Sponsors and Collaborators

    • University of Toronto
    • Ontario Ministry of Health and Long Term Care

    Investigators

    • Principal Investigator: Murray Krahn, PhD, MD, Director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Murray Krahn, Director, THETA, University of Toronto
    ClinicalTrials.gov Identifier:
    NCT01348841
    Other Study ID Numbers:
    • 25973
    First Posted:
    May 5, 2011
    Last Update Posted:
    Oct 25, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Murray Krahn, Director, THETA, University of Toronto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2013