The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
- Conditions
- Antibiotic Stewardship
- Registration Number
- NCT03517007
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 762
- 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.
- Adult patients who are located in ICU wards.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection 30 days post-randomization Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
- Secondary Outcome Measures
Name Time Method Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention 30 days post-randomization .Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention
Negative outcomes as measured by individual clinical outcome components in the DOOR 30 days post-randomization Negative outcomes as measured by individual clinical outcome components in the DOOR
Negative outcomes as measured by number of days patient has a central line 30 days post-randomization Negative outcomes as measured by number of days patient has a central line
percent of eligible patients with antibiotic de-escalation 5 days from initial date of suspected sepsis percent of eligible patients with antibiotic de-escalation
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 re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics
prescriber type within 3 days (96 hours) of initial date of suspected sepsis for prescribers who chose to opt out
prescribers' reported rationale for opting out within 3 days (96 hours) of initial date of suspected sepsis for prescribers who chose to opt out
Distributions of DOOR up to 2 years 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.
number of eligible patients in whom the prescriber chose to opt-out within 3 days (96 hours) of initial date of suspected sepsis for patients eligible for assessment of de-escalation
Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol 30 days post-randomization Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol
Negative outcomes as measured by length of hospital stay 30 days post-randomization Negative outcomes as measured by length of hospital stay
Number of patients in whom the safety screen was applied within 3 days (96 hours) of initial date of suspected sepsis for patients eligible for assessment of de-escalation
Number of patients the safety screen excluded from the opt-out procedure within 3 days (96 hours) of initial date of suspected sepsis for patients eligible for assessment of de-escalation
number of eligible patients in whom the opt-out procedure was applied within 3 days (96 hours) of initial date of suspected sepsis for patients eligible for assessment of de-escalation
Trial Locations
- Locations (10)
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Piedmont Fayette Hospital
🇺🇸Fayetteville, Georgia, United States
Piedmont Newnan Hospital
🇺🇸Newnan, Georgia, United States
Harvard Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States
Southeastern Regional Medical Center
🇺🇸Lumberton, North Carolina, United States
Iredell Health System
🇺🇸Statesville, North Carolina, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Presbyterian Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Piedmont Atlanta Hospital🇺🇸Atlanta, Georgia, United States