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

Primary Purpose

Wound of Skin

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Systematic referral to MDWCT and comprehensive primary care
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wound of Skin focused on measuring community wound care, systematic wound team referral, Advanced in-home nurse wound training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • THETA Collaborative

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2011
Last Updated
October 24, 2013
Sponsor
University of Toronto
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT01348841
Brief Title
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
Acronym
WIT
Official Title
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin
Keywords
community wound care, systematic wound team referral, Advanced in-home nurse wound training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Usual care is care as currently delivered to clients with chronic wounds in the community.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Systematic referral to MDWCT and comprehensive primary care
Other Intervention Name(s)
systematic expedited referral to MDWCTs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Healing
Description
The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
proportion of wound healed
Description
proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).
Time Frame
6 months
Title
Wound recurrence
Description
Wound recurrence within the study period.
Time Frame
6 months
Title
time to discontinuation of wound service
Description
Time to discontinuation of wound services within the CCAC and interdisciplinary teams.
Time Frame
1 years
Title
Health Related Quality of Life (HRQOL)
Description
Health related quality of life.
Time Frame
6 months
Title
client satisfaction
Description
Satisfaction with care.
Time Frame
6 months
Title
cost and resource use
Description
cost and resource use of wound care provided
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray Krahn, PhD, MD
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
THETA Collaborative
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3M2
Country
Canada

12. IPD Sharing Statement

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

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