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CompletedNCT01573832ICCP-WCUpdated Jul 18, 2016

Integrated Client Care Project Trial: Wound Care Evaluation

An interventional study of integrated client care group in Wound, sponsored by Sunnybrook Health Sciences Centre. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-18.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
13,999
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wound

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 859 are open to participants now.

This study's enrollment of 13,999 is above the median of 52 across 3,240 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 133 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients who do not receive wound care from Ontario Community Care Access Centres
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
13,999 participants (actual)

Study arms

  • Experimental
    Diabetic Foot Ulcer Intervention

    Other: integrated client care group

  • No intervention
    Diabetic Foot Ulcer Usual Care
  • Experimental
    Pionidal Sinus Ulcer Intervention

    Other: integrated client care group

  • No intervention
    Pionidal Sinus Ulcer Usual Care

Interventions

  • Otherintegrated client care group

    receives integrated client care for wound treatment

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What researchers measure

Primary outcomes

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

    percentage of patients whose wound heals within the outcomes benchmark

    Time frame: 1 year

Secondary outcomes

  1. time to wound healing outcomes

    time to wound healing outcomes

    Time frame: 1 year

  2. total patient length of stay

    total patient length of stay

    Time frame: at patient discharge, up to 365 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 28851413 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01573832
Lead sponsor
Sunnybrook Health Sciences Centre
Responsible party
Sponsor
First posted
Apr 10, 2012
Start date
Jun 2012
Primary completion
Jun 2014
Completion
Jan 2015
Last update
Jul 18, 2016

Study contacts

Merrick F Zwarenstein, MB, PhD
principal investigator · Sunnybrook and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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