The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Opt-Out Protocol 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
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.
|
| No Intervention: Standard of Care Provider continues routine, standard of care on the patient. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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 length of hospital stay [30 days post-randomization]
Negative outcomes as measured by length of hospital stay
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Piedmont Atlanta Hospital | Atlanta | Georgia | United States | 30309 |
| 2 | Piedmont Fayette Hospital | Fayetteville | Georgia | United States | 30214 |
| 3 | Piedmont Newnan Hospital | Newnan | Georgia | United States | 30265 |
| 4 | Harvard Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 5 | Duke University | Durham | North Carolina | United States | 27710 |
| 6 | Southeastern Regional Medical Center | Lumberton | North Carolina | United States | 28358 |
| 7 | Iredell Health System | Statesville | North Carolina | United States | 28677 |
| 8 | Wilson Medical Center | Wilson | North Carolina | United States | 27893 |
| 9 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | Pennsylvania Presbyterian Hospital | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Rebekah Moehring, MD, MPH, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00092813