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Clinical Trials/NCT06338176
NCT06338176CompletedNot Applicable

Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB): A Stepped Wedge Clinical Trial Evaluating the Effectiveness of a Centralized S. Aureus Management Model

University of Alberta202 sites in 1 country2,542 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,542
Locations
202
Primary Endpoint
Adherence to quality-of-care indicators

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Standard of care

No Intervention

OPTIMUS-SAB care pathway

Experimental

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).

Intervention: OPTIMUS-SAB clinical care pathway (Other)

Outcomes

Primary Outcomes

Adherence to quality-of-care indicators

Time Frame: Within 90 days

Defined as: 1. ID involvement and time to ID involvement, defined by the presence of an ID consult note and/or recommendations in the chart. 2. Repeat blood cultures, to document clearance of bacteremia, within 72 hours from the last positive blood culture. 3. Guideline-concordant empiric antibiotic administered and time to receipt. 4. Guideline concordant definitive antibiotic administered and time to receipt. 5. Therapeutic drug monitoring of patents treatments with vancomycin. 6. Appropriate dose adjustment of antimicrobials based on renal function according to local guidelines. 7. Echocardiogram (transthoracic or transesophageal) performed within 72 hours of diagnosis. 8. Source control achieved. 9. Appropriate duration of antibiotic therapy ordered and delivered.

Secondary Outcomes

  • In hospital mortality(90 days)
  • Costing evaluation(One year)
  • Implementation evaluation(3 years)
  • Hospital re-admission rates(90 days)
  • All-cause mortality(180 days)
  • Length of stay(180 days maximum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (202)

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