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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt-Out Protocol | Experimental | 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. |
|
| Standard of Care | No Intervention | Provider continues routine, standard of care on the patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opt-Out Protocol | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebekah Moehring, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States | ||
| Piedmont Fayette Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36167851 | Background | Moehring RW, Yarrington ME, Warren BG, Lokhnygina Y, Atkinson E, Bankston A, Collucio J, David MZ, Davis AE, Davis J, Dionne B, Dyer AP, Jones TM, Klompas M, Kubiak DW, Marsalis J, Omorogbe J, Orajaka P, Parish A, Parker T, Pearson JC, Pearson T, Sarubbi C, Shaw C, Spivey J, Wolf R, Wrenn RH, Dodds Ashley ES, Anderson DJ; Centers for Disease Control and Prevention's Prevention Epicenters Program. Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):433-442. doi: 10.1093/cid/ciac787. | |
| 36168480 |
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|
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 |
| Fayetteville |
| Georgia |
| 30214 |
| United States |
| Piedmont Newnan Hospital | Newnan | Georgia | 30265 | United States |
| Harvard Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Southeastern Regional Medical Center | Lumberton | North Carolina | 28358 | United States |
| Iredell Health System | Statesville | North Carolina | 28677 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Presbyterian Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| Background |
| Yarrington ME, Moehring RW, David MZ, Hamilton KW, Klompas M, Rhee C, Hsueh K, Ashley ED, Sinkowitz-Cochran RL, Ryan M, Anderson DJ; DETOURS Expert Panel of the CDC Prevention Epicenters Program. A modified Delphi approach to develop a trial protocol for antibiotic de-escalation in patients with suspected sepsis. Antimicrob Steward Healthc Epidemiol. 2021 Nov 8;1(1):e44. doi: 10.1017/ash.2021.205. eCollection 2021. |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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