IDEAS-CRXO: Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis
Study Details
Study Description
Brief Summary
As antibiotic resistance increases globally, it becomes more difficult to select empiric antibiotic therapy, particularly in patients with sepsis who stand to benefit from early adequate treatment. In particular it is difficult for clinicians to balance antibiotic stewardship principles (the need to avoid unnecessary prescribing of antibiotics that have an excessively broad spectrum of activity that favour resistance development) and under treatment. The integration of multiple risk variables for resistance are hard for clinicians to translate into clinical action, and is seemingly at odds with the natural inclination to provide heuristic/emotion-based antibiotic selection. The inappropriate treatment of sepsis is not uniformly too broad, or too narrow, and there is a need to optimize and tailor selection of antibiotic therapy to each patient, such that those that are at risk for resistant organisms receive broad therapy, and those that are not at risk, receive narrower antibiotic agents.
Clinicians need support picking the right antibiotic for each patient, and from this they can potentially drive reduction of unnecessarily broad antibiotic prescribing while preserving adequacy of treatment. Individualized clinical prediction models and decision support interventions are promising approaches that meet these needs by improving the classification of patient risk for antibiotic resistant or susceptible infections in sepsis. Unfortunately, few have been validated in the clinical setting and larger rigorous studies are needed to provide the evidence to support broader clinical adoption.
The investigators will perform a cluster randomized cross-over trial of an individualized antibiotic prescribing decision support intervention for providers treating hospitalized patients with suspected sepsis. The aim of this trial is to determine whether a stewardship led clinical decision support intervention can improve antibiotic de-escalation in patients with sepsis while maintaining or improving adequacy of antibiotic coverage. This decision support intervention will be based on a combination of proven decision heuristics (for Gram-positive organisms) and modelled predicted susceptibilities (for Gram-negative organisms) that are individualized to the patient. The primary outcome will be the proportion of patients de-escalated from their initial empiric regimen within 48 hours.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis The planned intervention consists of a pharmacist-facilitated clinical decision support intervention, where pharmacists provide options and recommendations on empiric sepsis antibiotic selection to hospital providers. |
Other: Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis
A clinical decision support algorithm for empiric antibiotic selection in suspected infection.
Other Names:
|
| No Intervention: Standard of Care Non-intervention group. No decision support is provided. Patient care is routine. |
Outcome Measures
Primary Outcome Measures
- Number of Patients De-escalated [48 hours]
De-escalation from empiric antibiotic regimen within 48 hours of receipt of antibiotics [Binary].
Secondary Outcome Measures
- Time to adequate therapy [0-7 days]
Time to adequate therapy for patients with positive blood cultures (hours from time of blood culture collection to first dose of agent(s) active against all pathogen(s) in the positive culture).
- Number of Patients Receiving Adequate Therapy at 48 hours [48 hours]
Receipt of adequate antibiotic therapy within 48 hours from blood culture collection for patients with positive cultures.
- Mortality [90 days]
In-hospital mortality, during index admission, and within 90 days of index event.
- Length of stay [0-90 days]
Hospital length of stay on index admission (days).
- De-escalation extent [48 hours]
Extent of antibiotic de-escalation (ordinal value up or down the de-escalation cascade)
- Antibiotic spectrum at completion [Completion of therapy, up to 90 days]
Antibiotic spectrum ranking on the last day of antibiotic treatment.
- C.difficile Infection [90 days]
Positive stool testing for C. difficile during index admission, and within 90 days of index.
- Dialysis [90 days]
New requirement for dialysis during index admission, and within 90 days of index.
- Days of antibiotic therapy [End of index admission, up to 90 days]
Total antibiotic days of therapy (DOT) during index admission, including by spectrum-level.
- Escalation [48hrs]
Newly started Gram-positive or Gram-negative coverage, or increases in spectrum of antibiotic therapy, as part of the intervention recommendation.
- Recommended change in Gram-negative coverage [At time of assessment]
Recommended change in antibiotic therapy by Gram-negative model.
- Accepted change in Gram-negative coverage [At time of assessment]
Recommended change in antibiotic therapy by Gram-negative model was accepted and ordered.
- Recommended change in Gram-positive coverage [at time of assessment]
Recommended change in antibiotic therapy by Gram-positive algorithm.
- Accepted change in Gram-positive coverage [At 48 hrs]
Recommended change in antibiotic therapy by Gram-positive algorithm was accepted and ordered.
- Non-recommended escalation at 7 days [7 days]
Escalation of antibiotic therapy (apart from recommended escalation) within 7 days of receipt of initial antibiotics
- ICU admit or mortality [7 days]
ICU admission or death at 7 days from receipt of initial antibiotics
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Admitted
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Age >18 years old
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Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):
- Vancomycin II. Linezolid III. Daptomycin IV. Cefazolin V. Cloxacillin VI. Ceftriaxone VII. Ceftazidime VIII. Piperacillin-Tazobactam IX. Meropenem (or Imipenem or Ertapenem) X. Ciprofloxacin (or Moxifloxacin or Levofloxacin) XI. Gentamicin (or Tobramycin).
- Blood cultures ordered (within 12 hours before or after initiation of antibiotics).
Exclusion Criteria:
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Documented end-of-life (palliative) care.
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Already enrolled in the trial.
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Positive clinical culture results for the index infection already available prior to giving advice.
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Receipt of antimicrobials (not chronic suppression) in the prior 24-72 hours.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ottawa Hospital Research Institute
- Canadian Institutes of Health Research (CIHR)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230322-01T