Integrated Client Care Project Trial: Wound Care Evaluation

NCT ID: NCT01573832

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13999 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Diabetic Foot Ulcer Intervention

Group Type: EXPERIMENTAL

integrated client care group

Intervention Type: OTHER

receives integrated client care for wound treatment

Diabetic Foot Ulcer Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pionidal Sinus Ulcer Intervention

Group Type: EXPERIMENTAL

integrated client care group

Intervention Type: OTHER

receives integrated client care for wound treatment

Pionidal Sinus Ulcer Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

integrated client care group

receives integrated client care for wound treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merrick F Zwarenstein, MB, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook and Women's Hospital

References

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.

Reference Type: DERIVED

PMID: 28851413 (View on PubMed)

Other Identifiers

11-289c

Identifier Type: -

Identifier Source: org_study_id