- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06338176
Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB)
Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB): A Stepped Wedge Clinical Trial Evaluating the Effectiveness of a Centralized S. Aureus Management Model
Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.
Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.
The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
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Athabasca, Alberta, Canada
- Athabasca Healthcare Centre
-
Banff, Alberta, Canada
- Mineral Springs Hospital
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Barrhead, Alberta, Canada
- Barrhead Healthcare Centre
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Bassano, Alberta, Canada
- Bassano Health Centre
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Beaverlodge, Alberta, Canada
- Beaverlodge Municipal Hospital
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Black Diamond, Alberta, Canada
- Oilfields General Hospital
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Bonnyville, Alberta, Canada
- Bonnyville Healthcare Centre
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Bow Island, Alberta, Canada
- Bow Island Health Centre
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Boyle, Alberta, Canada
- Boyle Healthcare Centre
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Brooks, Alberta, Canada
- Brooks Health Centre
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Calgary, Alberta, Canada
- Foothills Medical Centre
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Calgary, Alberta, Canada
- Tom Baker Cancer Centre
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Calgary, Alberta, Canada
- South Health Campus
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Calgary, Alberta, Canada
- Peter Lougheed Centre
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Calgary, Alberta, Canada
- Arthur J.E. Child Comprehensive Cancer Centre
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Camrose, Alberta, Canada
- St. Mary's Hospital
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Canmore, Alberta, Canada
- Canmore General Hospital
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Cardston, Alberta, Canada
- Cardston Health Centre
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Castor, Alberta, Canada
- Our Lady of the Rosary Hospital
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Claresholm, Alberta, Canada
- Claresholm General Hospital
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Coaldale, Alberta, Canada
- Coaldale Health Centre
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Cold Lake, Alberta, Canada
- Cold Lake Healthcare Centre
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Consort, Alberta, Canada
- Consort Hospital and Care Centre
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Coronation, Alberta, Canada
- Coronation Hospital and Care Centre
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Crowsnest Pass, Alberta, Canada
- Crowsnest Pass Health Centre
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Daysland, Alberta, Canada
- Daysland Health Centre
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Devon, Alberta, Canada
- Devon General Hospital
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Didsbury, Alberta, Canada
- Didsbury District Health Services
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Drayton Valley, Alberta, Canada
- Drayton Valley Hospital and Care Centre
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Drumheller, Alberta, Canada
- Drumheller Health Centre
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Edmonton, Alberta, Canada
- Royal Alexandra Hospital
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Edmonton, Alberta, Canada
- University of Alberta Hospital
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Edmonton, Alberta, Canada
- Cross Cancer Institute
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Edmonton, Alberta, Canada
- Grey Nuns Community Hospital
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Edmonton, Alberta, Canada
- Glenrose Rehabilitation Hospital
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Edmonton, Alberta, Canada
- Misericordia Community Hospital
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Edson, Alberta, Canada
- Edson Healthcare Centre
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Elk Point, Alberta, Canada
- Elk Point Healthcare Centre
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Fairview, Alberta, Canada
- Fairview Health Complex
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Fort McMurray, Alberta, Canada
- Northern Lights Regional Health Centre
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Fort Vermilion, Alberta, Canada
- St. Theresa General Hospital
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Fox Creek, Alberta, Canada
- Fox Creek Healthcare Centre
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Ft Saskatchewan, Alberta, Canada
- Fort Saskatchewan Community Hospital
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Grande Cache, Alberta, Canada
- Grande Cache Community Health Complex
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Grande Prairie, Alberta, Canada
- Grande Prairie Regional Hospital
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Grimshaw, Alberta, Canada
- Grimshaw / Berwyn and District Community Health Centre
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Hanna, Alberta, Canada
- Hanna Health Centre
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Hardisty, Alberta, Canada
- Hardisty Health Centre
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High Level, Alberta, Canada
- Northwest Health Centre
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High Prairie, Alberta, Canada
- High Prairie Health Complex
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High River, Alberta, Canada
- High River General Hospital
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Hinton, Alberta, Canada
- Hinton Healthcare Centre
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Innisfail, Alberta, Canada
- Innisfail Health Centre
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Jasper, Alberta, Canada
- Seton - Jasper Healthcare Centre
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Killam, Alberta, Canada
- Killam Health Centre
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Lac La Biche, Alberta, Canada
- William J Cadzow - Lac La Biche Health Care Centre
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Lacombe, Alberta, Canada
- Lacombe Hospital
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Lamont, Alberta, Canada
- Lamont Health Centre
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Leduc, Alberta, Canada
- Leduc Community Hospital
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Lethbridge, Alberta, Canada
- Chinook Regional Hospital
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Lloydminster, Alberta, Canada
- Lloydminster Hospital
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Manning, Alberta, Canada
- Manning Community Health Centre
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Mayerthorpe, Alberta, Canada
- Mayerthorpe Healthcare Centre
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McLennan, Alberta, Canada
- Sacred Heart Community Healt
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Medicine Hat, Alberta, Canada
- Medicine Hat Regional Hospital
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Olds, Alberta, Canada
- Olds Hospital and Care Centre
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Oyen, Alberta, Canada
- Big Country Hospital
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Peace River, Alberta, Canada
- Peace River Community Health Centre
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Pincher Creek, Alberta, Canada
- Pincher Creek Health Centre
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Ponoka, Alberta, Canada
- Ponoka Hospital
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Provost, Alberta, Canada
- Provost Health Centre
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Raymond, Alberta, Canada
- Raymond Health Centre
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Red Deer, Alberta, Canada
- Red Deer Regional Hospital Centre
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Redwater, Alberta, Canada
- Redwater Health Centre
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Rimbey, Alberta, Canada
- Rimbey Hospital
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Rocky Mountain House, Alberta, Canada
- Rocky Mountain House Health Centre
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Rockyview, Alberta, Canada
- Rockyview General Hospital
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Slave Lake, Alberta, Canada
- Slave Lake Healthcare Centre
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Smoky Lake, Alberta, Canada
- George McDougall - Smoky Lake Healthcare Centre
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Spirit River, Alberta, Canada
- Central Peace Health Complex
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St. Albert, Alberta, Canada
- Sturgeon Community Hospital
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St. Paul, Alberta, Canada
- St. Therese - St. Paul Healthcare Centre
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Stettler, Alberta, Canada
- Stettler Hospital
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Strathmore, Alberta, Canada
- Strathmore District Health Services
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Sundre, Alberta, Canada
- Myron Thompson Health Centre
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Swan Hills, Alberta, Canada
- Swan Hills Healthcare Centre
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Taber, Alberta, Canada
- Taber Health Centre
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Three Hills, Alberta, Canada
- Three Hills Health Centre
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Tofield, Alberta, Canada
- Tofield Health Centre
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Two Hills, Alberta, Canada
- Two Hills Health Centre
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Valleyview, Alberta, Canada
- Valleyview Health Centre
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Vegreville, Alberta, Canada
- St. Joseph's General Hospital
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Vermilion, Alberta, Canada
- Vermilion Health Centre
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Viking, Alberta, Canada
- Viking Health Centre
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Vulcan, Alberta, Canada
- Vulcan Community Health Centre
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Wabasca, Alberta, Canada
- Wabasca/Desmarais Healthcare Centre
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Wainwright, Alberta, Canada
- Wainwright Health Centre
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Westlock, Alberta, Canada
- Westlock Healthcare Centre
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Westview Village, Alberta, Canada
- Westview Health Centre
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Wetaskiwin, Alberta, Canada
- Wetaskiwin Hospital
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Whitecourt, Alberta, Canada
- Whitecourt Healthcare Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age greater than 18 years at the time of hospital admission
- Confirmed S. aureus bacteremia by blood culture performed at a laboratory in Alberta, Canada
- Admitted to a designated acute care site in Alberta, Canada
Exclusion Criteria:
- The treating team believes death is imminent or inevitable .
- GCD are C-level within 48 hours of admission.
- The patient is transferred in from an out-of-province acute care center with a pre-existing SAB diagnosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of care
|
|
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Experimental: OPTIMUS-SAB care pathway
Province-wide real time automated notifications of new SAB cases will be established and delivered to a centralized SAB care team electronically through Connect Care.
The centralized SAB care team consists of a SAB clinical coordinator, ID specialists and other ad hoc representation depending on patient needs.
Following patient chart review, the centralized SAB care team contacts the most responsible physician (MRP) to provide preliminary recommendations to optimize care, both verbally and in written format, facilitated by Connect Care (Alberta Health Services electronic medical record).
|
Activation of SAB clinical care pathway within EMR system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to quality-of-care indicators
Time Frame: Within 90 days
|
Defined as:
|
Within 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: 180 days maximum
|
Acute hospital length of stay
|
180 days maximum
|
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Hospital re-admission rates
Time Frame: 90 days
|
re-admission to acute care rate
|
90 days
|
|
All-cause mortality
Time Frame: 180 days
|
death from any cause
|
180 days
|
|
In hospital mortality
Time Frame: 90 days
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death within hospital stay
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90 days
|
|
Costing evaluation
Time Frame: One year
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Cost of SAB treatment related to hospitalization, including physician provision of care, and antibiotics.
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One year
|
|
Implementation evaluation
Time Frame: 3 years
|
User experience and feedback from patients and providers will be collected at the start and end of each active implementation phase.
This information will be paired with assessments of barriers, facilitators, and contextual factors informed by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory during the pre-implementation phase and at the end of active implementation.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Justin Chen, MD, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00128904
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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