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
About this trial
This is an interventional health services research trial for Wound
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
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
NCT ID
NCT01573832
First Posted
January 13, 2012
Last Updated
July 14, 2016
Sponsor
Sunnybrook Health Sciences Centre
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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