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

Not Applicable

Completed

• Conditions: Antibiotic Stewardship
• Interventions: Other: Opt-Out Protocol

• 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

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-07
• Study Start: 2018-09-12
• Status Verified: 2020-08
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-10
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 762

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.

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Exclusion Criteria

• Adult patients who are located in ICU wards.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opt-Out Protocol	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.

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)

Iredell Health System; 🇺🇸 Statesville, North Carolina, United States

Pennsylvania Presbyterian Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Southeastern Regional Medical Center; 🇺🇸 Lumberton, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Piedmont Fayette Hospital; 🇺🇸 Fayetteville, Georgia, United States

Piedmont Atlanta Hospital; 🇺🇸 Atlanta, Georgia, United States

Piedmont Newnan Hospital; 🇺🇸 Newnan, Georgia, United States

Harvard Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Wilson Medical Center; 🇺🇸 Wilson, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States