The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial

Study Overview
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Brief Summary
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The objective of this study is to implement an opt-out protocol to guide appropriate de-escalation of antibiotics in qualifying patients. The protocol, determined over the course a year with the help of a large, well-rounded expert panel, will be used by pharmacists to recommend de-escalation of antibiotics to hospital providers. Providers can then decide whether or not to follow the recommendation in determining the best treatment pathway for his or her patient.

Official Title
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The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial

Conditions
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Antibiotic Stewardship

Intervention / Treatment
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* Other: Opt-Out Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood culture preliminary results that indicate no growth as of 48-96 hours. (Exception: Patients with a single positive blood culture for coagulase negative Staphylococcus and no central line in place will also be included). Still on broad spectrum antibiotic therapy after 48-96 hours. Exclusion Criteria: Adult patients who are located in ICU wards.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opt-Out Protocol<br>Should an eligible patient pass the safety screen and be randomized to the intervention arm of the trial, the designated pharmacist will approach the patient's primary provider in charge of antibiotic decision-making The pharmacist will inform the provider the patient's antibiotics can be de-escalated unless the provider opts out. | Other: Opt-Out Protocol<br>* Should an eligible patient pass the safety screen and be randomized to the intervention arm of the trial, the designated pharmacist will approach the patient's primary provider in charge of antibiotic decision-making The pharmacist will inform the provider the patient's antibiotics can be de-escalated unless the provider opts out.<br>|
| No Intervention: Standard of Care<br>Provider continues routine, standard of care on the patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection | Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection | 30 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distributions of DOOR | DOOR is defined as Desirability of Outcome Ranking, from Alive being a rank of 1 to Death being a rank of 6. DOOR will be applied to collected patient data. | up to 2 years | 
| Negative outcomes as measured by individual clinical outcome components in the DOOR | Negative outcomes as measured by individual clinical outcome components in the DOOR | 30 days post-randomization | 
| Negative outcomes as measured by length of hospital stay | Negative outcomes as measured by length of hospital stay | 30 days post-randomization | 
| Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics | Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics | 30 days post-randomization | 
| Negative outcomes as measured by number of days patient has a central line | Negative outcomes as measured by number of days patient has a central line | 30 days post-randomization | 
| percent of eligible patients with antibiotic de-escalation | percent of eligible patients with antibiotic de-escalation | 5 days from initial date of suspected sepsis | 
| Number of patients in whom the safety screen was applied | for patients eligible for assessment of de-escalation | within 3 days (96 hours) of initial date of suspected sepsis | 
| Number of patients the safety screen excluded from the opt-out procedure | for patients eligible for assessment of de-escalation | within 3 days (96 hours) of initial date of suspected sepsis | 
| number of eligible patients in whom the opt-out procedure was applied | for patients eligible for assessment of de-escalation | within 3 days (96 hours) of initial date of suspected sepsis | 
| number of eligible patients in whom the prescriber chose to opt-out | for patients eligible for assessment of de-escalation | within 3 days (96 hours) of initial date of suspected sepsis | 
| prescriber type | for prescribers who chose to opt out | within 3 days (96 hours) of initial date of suspected sepsis | 
| prescribers' reported rationale for opting out | for prescribers who chose to opt out | within 3 days (96 hours) of initial date of suspected sepsis | 
| Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol | Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol | 30 days post-randomization | 
| Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention | .Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention | 30 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic de-escalation, sepsis, antimicrobial stewardship