NCT01573832

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,999

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

January 13, 2012

Last Update Submit

July 14, 2016

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • percentage of patients whose wound heals within the outcomes benchmark

    percentage of patients whose wound heals within the outcomes benchmark

    1 year

Secondary Outcomes (2)

  • time to wound healing outcomes

    1 year

  • total patient length of stay

    at patient discharge, up to 365 days

Study Arms (4)

Diabetic Foot Ulcer Intervention

EXPERIMENTAL
Other: integrated client care group

Diabetic Foot Ulcer Usual Care

NO INTERVENTION

Pionidal Sinus Ulcer Intervention

EXPERIMENTAL
Other: integrated client care group

Pionidal Sinus Ulcer Usual Care

NO INTERVENTION

Interventions

integrated client care groupOTHER

receives integrated client care for wound treatment

Diabetic Foot Ulcer InterventionPionidal Sinus Ulcer Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28851413DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Merrick F Zwarenstein, MB, PhD

    Sunnybrook and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

April 10, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

July 18, 2016

Record last verified: 2016-07