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OpenTrials
Completed

NCT Number: NCT06338176

Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB)

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.

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Key information

Conditions

Staph Aureus Bacteremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athabasca Healthcare Centre, Athabasca, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OPTIMUS-SAB clinical care pathway

Other

Activation of SAB clinical care pathway within EMR system.

Primary outcomes

  1. Adherence to quality-of-care indicators

    Time frame: Within 90 days

    Defined as:

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

Secondary outcomes

  1. Length of stay

    Time frame: 180 days maximum

    Acute hospital length of stay

  2. Hospital re-admission rates

    Time frame: 90 days

    re-admission to acute care rate

  3. All-cause mortality

    Time frame: 180 days

    death from any cause

  4. In hospital mortality

    Time frame: 90 days

    death within hospital stay

  5. Costing evaluation

    Time frame: One year

    Cost of SAB treatment related to hospitalization, including physician provision of care, and antibiotics.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.