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

Primary Purpose

Antibiotic Stewardship

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opt-Out Protocol
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic Stewardship focused on measuring antibiotic de-escalation, sepsis, antimicrobial stewardship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Piedmont Atlanta Hospital
  • Piedmont Fayette Hospital
  • Piedmont Newnan Hospital
  • Harvard Brigham and Women's Hospital
  • Duke University
  • Southeastern Regional Medical Center
  • Iredell Health System
  • Wilson Medical Center
  • Hospital of the University of Pennsylvania
  • Pennsylvania Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Opt-Out Protocol

Standard of Care

Arm Description

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.

Provider continues routine, standard of care on the patient.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Negative outcomes as measured by individual clinical outcome components in the DOOR
Negative outcomes as measured by individual clinical outcome components in the DOOR
Negative outcomes as measured by length of hospital stay
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
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
Negative outcomes as measured by number of days patient has a central line
percent of eligible patients with antibiotic de-escalation
percent of eligible patients with antibiotic de-escalation
Number of patients in whom the safety screen was applied
for patients eligible for assessment of de-escalation
Number of patients the safety screen excluded from the opt-out procedure
for patients eligible for assessment of de-escalation
number of eligible patients in whom the opt-out procedure was applied
for patients eligible for assessment of de-escalation
number of eligible patients in whom the prescriber chose to opt-out
for patients eligible for assessment of de-escalation
prescriber type
for prescribers who chose to opt out
prescribers' reported rationale for opting out
for prescribers who chose to opt out
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
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

Full Information

First Posted
May 3, 2018
Last Updated
August 11, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03517007
Brief Title
The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Official Title
The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Stewardship
Keywords
antibiotic de-escalation, sepsis, antimicrobial stewardship

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
762 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opt-Out Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Provider continues routine, standard of care on the patient.
Intervention Type
Other
Intervention Name(s)
Opt-Out Protocol
Intervention Description
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 Measure Information:
Title
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
Description
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
Time Frame
30 days post-randomization
Secondary Outcome Measure Information:
Title
Distributions of DOOR
Description
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
Title
Negative outcomes as measured by individual clinical outcome components in the DOOR
Description
Negative outcomes as measured by individual clinical outcome components in the DOOR
Time Frame
30 days post-randomization
Title
Negative outcomes as measured by length of hospital stay
Description
Negative outcomes as measured by length of hospital stay
Time Frame
30 days post-randomization
Title
Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics
Description
Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics
Time Frame
30 days post-randomization
Title
Negative outcomes as measured by number of days patient has a central line
Description
Negative outcomes as measured by number of days patient has a central line
Time Frame
30 days post-randomization
Title
percent of eligible patients with antibiotic de-escalation
Description
percent of eligible patients with antibiotic de-escalation
Time Frame
5 days from initial date of suspected sepsis
Title
Number of patients in whom the safety screen was applied
Description
for patients eligible for assessment of de-escalation
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
Number of patients the safety screen excluded from the opt-out procedure
Description
for patients eligible for assessment of de-escalation
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
number of eligible patients in whom the opt-out procedure was applied
Description
for patients eligible for assessment of de-escalation
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
number of eligible patients in whom the prescriber chose to opt-out
Description
for patients eligible for assessment of de-escalation
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
prescriber type
Description
for prescribers who chose to opt out
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
prescribers' reported rationale for opting out
Description
for prescribers who chose to opt out
Time Frame
within 3 days (96 hours) of initial date of suspected sepsis
Title
Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol
Description
Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol
Time Frame
30 days post-randomization
Title
Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention
Description
.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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebekah Moehring, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Piedmont Newnan Hospital
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Harvard Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Southeastern Regional Medical Center
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Facility Name
Iredell Health System
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Presbyterian Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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