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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
762
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.
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Piedmont Newnan Hospital
Newnan, Georgia, United States
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
Time frame: 30 days post-randomization
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.
Time frame: 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
Time frame: 30 days post-randomization
Negative outcomes as measured by length of hospital stay
Negative outcomes as measured by length of hospital stay
Time frame: 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
Time frame: 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
Time frame: 30 days post-randomization
percent of eligible patients with antibiotic de-escalation
percent of eligible patients with antibiotic de-escalation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
prescriber type
for prescribers who chose to opt out
Time frame: within 3 days (96 hours) of initial date of suspected sepsis
prescribers' reported rationale for opting out
for prescribers who chose to opt out
Time frame: 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
Time frame: 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
Time frame: 30 days post-randomization