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: Not yet recruiting
• Conditions: Staph Aureus Bacteremia
• Intervention / Treatment: Other: OPTIMUS-SAB clinical care pathway

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin Chen, MD; Phone Number: 780-492-5936; Email: jzchen@ualberta.ca
• Study Contact Backup: Name: Holly Hoang, MD; Phone Number: 780-492-5936; Email: hlhoang@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
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).	Other: OPTIMUS-SAB clinical care pathway; 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	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.	Within 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Acute hospital length of stay	180 days maximum
Hospital re-admission rates	re-admission to acute care rate	90 days
All-cause mortality	death from any cause	180 days
In hospital mortality	death within hospital stay	90 days
Costing evaluation	Cost of SAB treatment related to hospitalization, including physician provision of care, and antibiotics.	One year
Implementation evaluation	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: University of Alberta
• Collaborators: Alberta Health services
• Investigators: Principal Investigator: Justin Chen, MD, University of Alberta

Publications and helpful links

General Publications

• Remtulla S, Zurek K, Cervera C, Hernandez C, Lee MC, Hoang HL. Impact of an Unsolicited, Standardized Form-Based Antimicrobial Stewardship Intervention to Improve Guideline Adherence in the Management of Staphylococcus aureus Bacteremia. Open Forum Infect Dis. 2019 Feb 26;6(4):ofz098. doi: 10.1093/ofid/ofz098. eCollection 2019 Apr.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: care pathway; infectious disease consultation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: Pro00128904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No