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

July 14, 2016 updated by: Sunnybrook Health Sciences Centre

Integrated Client Care Project Randomized Control Trial: Wound Care Evaluation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13999

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of patients whose wound heals within the outcomes benchmark
Time Frame: 1 year
percentage of patients whose wound heals within the outcomes benchmark
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to wound healing outcomes
Time Frame: 1 year
time to wound healing outcomes
1 year
total patient length of stay
Time Frame: at patient discharge, up to 365 days
total patient length of stay
at patient discharge, up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Merrick F Zwarenstein, MB, PhD, Sunnybrook and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-289c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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