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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Murray Krahn, University of Toronto
ClinicalTrials.gov Identifier:
NCT01348841
First received: May 4, 2011
Last updated: October 24, 2013
Last verified: October 2013

May 4, 2011
October 24, 2013
May 2011
June 2013   (final data collection date for primary outcome measure)
Time to Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
Time to Healing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
Complete list of historical versions of study NCT01348841 on ClinicalTrials.gov Archive Site
  • proportion of wound healed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
  • Wound recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Wound recurrence within the study period.
  • time to discontinuation of wound service [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
  • Health Related Quality of Life (HRQOL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Health related quality of life.
  • client satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Satisfaction with care.
  • cost and resource use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cost and resource use of wound care provided
  • proportion of wound healed [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
  • Wound recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Wound recurrence within the study period.
  • time to discontinuation of wound service [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
  • HRQOL [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Health related quality of life.
  • client satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Satisfaction with care.
  • cost and resource use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    cost and resource use of wound care provided
Not Provided
Not Provided
 
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Wound of Skin
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 Name: systematic expedited referral to MDWCTs
  • 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.

    Intervention: Other: Systematic referral to MDWCT and comprehensive primary care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
451
October 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01348841
25973
No
Murray Krahn, University of Toronto
University of Toronto
Ontario Ministry of Health and Long Term Care
Principal Investigator: Murray Krahn, PhD, MD Director
University of Toronto
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP