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Integrated Client Care Project Trial: Wound Care Evaluation (ICCP-WC)

Primary Purpose

Wound

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
integrated client care group
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wound

Eligibility Criteria

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

Inclusion Criteria:

  • receives wound care from Community Care Access Centre provider
  • adults over age 18 in Ontario

Exclusion Criteria:

  • patients who do not receive wound care from Ontario Community Care Access Centres

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    No Intervention

    Experimental

    No Intervention

    Arm Label

    Diabetic Foot Ulcer Intervention

    Diabetic Foot Ulcer Usual Care

    Pionidal Sinus Ulcer Intervention

    Pionidal Sinus Ulcer Usual Care

    Arm Description

    Outcomes

    Primary Outcome Measures

    percentage of patients whose wound heals within the outcomes benchmark
    percentage of patients whose wound heals within the outcomes benchmark

    Secondary Outcome Measures

    time to wound healing outcomes
    time to wound healing outcomes
    total patient length of stay
    total patient length of stay

    Full Information

    First Posted
    January 13, 2012
    Last Updated
    July 14, 2016
    Sponsor
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01573832
    Brief Title
    Integrated Client Care Project Trial: Wound Care Evaluation
    Acronym
    ICCP-WC
    Official Title
    Integrated Client Care Project Randomized Control Trial: Wound Care Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will use a randomized control trial design to compare wound care clients who receive "integrated care" versus "usual care" in Community Care Access Centres (CCAC) in Ontario. Data will be collected by existing administrative databases and linked by the Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these databases and report findings.
    Detailed Description
    The researchers are interested in finding out whether the intervention ("integrated care") helps to improve patient outcomes. A randomized control trial of wound care clients in Ontario CCACs will show the effects of the intervention (integrated care) versus "usual care" clients. The researchers will also examine the financial system costs associated with providing "integrated care" to clients versus "usual care". The researchers expect to answer the research question of whether there is difference in patient outcomes between "integrated care" versus "usual care clients." The researchers also would like to formulate a response for whether there will be financial system cost difference between "integrated care" and "usual care" clients. The goal of this evaluation is to help decision-makers in the Ministry of Health and Long Term Care (MOHLTC), in the Community Care Access Centres (CCACs) and among provider organizations to improve the quality of care and patient outcomes for wound care clients, by evaluating innovations in the delivery of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    13999 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diabetic Foot Ulcer Intervention
    Arm Type
    Experimental
    Arm Title
    Diabetic Foot Ulcer Usual Care
    Arm Type
    No Intervention
    Arm Title
    Pionidal Sinus Ulcer Intervention
    Arm Type
    Experimental
    Arm Title
    Pionidal Sinus Ulcer Usual Care
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    integrated client care group
    Intervention Description
    receives integrated client care for wound treatment
    Primary Outcome Measure Information:
    Title
    percentage of patients whose wound heals within the outcomes benchmark
    Description
    percentage of patients whose wound heals within the outcomes benchmark
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    time to wound healing outcomes
    Description
    time to wound healing outcomes
    Time Frame
    1 year
    Title
    total patient length of stay
    Description
    total patient length of stay
    Time Frame
    at patient discharge, up to 365 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: receives wound care from Community Care Access Centre provider adults over age 18 in Ontario Exclusion Criteria: patients who do not receive wound care from Ontario Community Care Access Centres
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merrick F Zwarenstein, MB, PhD
    Organizational Affiliation
    Sunnybrook and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28851413
    Citation
    Zwarenstein M, Shariff S, Mittmann N, Stern A, Dainty KN. A large cluster randomized trial of outcome-based pathways to improve home-based wound care. Trials. 2017 Aug 29;18(1):393. doi: 10.1186/s13063-017-2082-5.
    Results Reference
    derived

    Learn more about this trial

    Integrated Client Care Project Trial: Wound Care Evaluation

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