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

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ClinicalTrials.gov Identifier: NCT01573832
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Wound Other: integrated client care group

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Integrated Client Care Project Randomized Control Trial: Wound Care Evaluation
Study Start Date : June 2012
Primary Completion Date : June 2014
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Diabetic Foot Ulcer Intervention Other: integrated client care group
receives integrated client care for wound treatment
No Intervention: Diabetic Foot Ulcer Usual Care
Experimental: Pionidal Sinus Ulcer Intervention Other: integrated client care group
receives integrated client care for wound treatment
No Intervention: Pionidal Sinus Ulcer Usual Care


Outcome Measures

Primary Outcome Measures :
  1. percentage of patients whose wound heals within the outcomes benchmark [ Time Frame: 1 year ]
    percentage of patients whose wound heals within the outcomes benchmark


Secondary Outcome Measures :
  1. time to wound healing outcomes [ Time Frame: 1 year ]
    time to wound healing outcomes

  2. total patient length of stay [ Time Frame: at patient discharge, up to 365 days ]
    total patient length of stay


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573832


Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Merrick F Zwarenstein, MB, PhD Sunnybrook and Women's Hospital
More Information

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01573832     History of Changes
Other Study ID Numbers: 11-289c
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Wounds and Injuries