- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697096
The INSPIRE-ASP UTI Trial
INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI): The INSPIRE-ASP UTI Trial
The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen.
Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Riverside, California, United States, 92501
- Riverside Community Hospital
-
San Jose, California, United States, 95116
- Regional Medical Center of San Jose
-
Thousand Oaks, California, United States, 91360
- Los Robles Regional Medical Center
-
-
Colorado
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Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
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Denver, Colorado, United States, 80220
- Rose Medical Center
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Denver, Colorado, United States, 80113
- Swedish Medical Center
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Denver, Colorado, United States, 80124
- Sky Ridge Medical Center
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Florida
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Brandon, Florida, United States, 33511
- Brandon Hospital
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Fort Walton Beach, Florida, United States, 32547
- Fort Walton Medical Center
-
Gainesville, Florida, United States, 32605
- North Florida Regional Medical Center
-
Kissimmee, Florida, United States, 34741
- Osceola Regional Medical Center
-
Kissimmee, Florida, United States, 34758
- Poinciana Medical Center
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Lake City, Florida, United States, 32055
- Lake City Medical Center
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Largo, Florida, United States, 33770
- Largo Medical Center
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Margate, Florida, United States, 33063
- Northwest Medical Center
-
Miami, Florida, United States, 33175
- Kendall Regional Medical Center
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Niceville, Florida, United States, 32578
- Twin Cities Hospital
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Palatka, Florida, United States, 80218
- Putnam Community Medical Center
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Panama City, Florida, United States, 32405
- Gulf Coast Medical Center
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Plantation, Florida, United States, 33324
- Westside Regional Medical Center
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Port Charlotte, Florida, United States, 33952
- Fawcett Memorial Hospital
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Port Saint Lucie, Florida, United States, 34952
- St. Lucie Medical Center
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Sanford, Florida, United States, 32771
- Central Florida Regional Hospital
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Sarasota, Florida, United States, 34233
- Doctor's Hospital Sarasota
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Tallahassee, Florida, United States, 32308
- Capital Regional Medical Center
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Trinity, Florida, United States, 34655
- Medical Center of Trinity
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Georgia
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Cartersville, Georgia, United States, 30120
- Cartersville Medical Center
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Dublin, Georgia, United States, 31021
- Fairview Park
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Rome, Georgia, United States, 30165
- Redmond Regional Medical Center
-
-
Idaho
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Caldwell, Idaho, United States, 83605
- West Valley Medical Center
-
-
Indiana
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Terre Haute, Indiana, United States, 47802
- Terre Haute Regional Hospital
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University Hospital & Clinic
-
-
Missouri
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Independence, Missouri, United States, 64057
- Centerpoint Medical Center
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Kansas City, Missouri, United States, 64132
- Research Medical Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89148
- Southern Hills Hospital - Vegas
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-
Tennessee
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Dickson, Tennessee, United States, 37055
- TriStar Horizon Medical Center
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Nashville, Tennessee, United States, 37167
- Stonecrest Medical Center
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-
Texas
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Austin, Texas, United States, 78705
- St. David's Medical Center
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Austin, Texas, United States, 78704
- South Austin Hospital
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Brownsville, Texas, United States, 78526
- Valley Regional Medical Center
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Conroe, Texas, United States, 77304
- Conroe Regional Medical Center
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Corpus Christi, Texas, United States, 78411
- Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
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Denton, Texas, United States, 76210
- Medical City Denton
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Fort Worth, Texas, United States, 76104
- Medical City Fort Worth
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Houston, Texas, United States, 77082
- West Houston Medical Center
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Kingwood, Texas, United States, 77339
- Kingwood Medical Center
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McAllen, Texas, United States, 78503
- Rio Grande Regional Hospital
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North Richland Hills, Texas, United States, 76180
- North Hills Hospital
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Pasadena, Texas, United States, 77504
- Bayshore Medical Center
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Plano, Texas, United States, 75075
- Medical City Plano
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Round Rock, Texas, United States, 78681
- Round Rock Hospital
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San Antonio, Texas, United States, 78212
- Metropolitan Methodist Hospital
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Webster, Texas, United States, 77598
- Clearlake Regional Medical Center
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Virginia
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Blacksburg, Virginia, United States, 24060
- LewisGale Hospital - Montgomery
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Hopewell, Virginia, United States, 23860
- John Randolph Medical Center
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Pulaski, Virginia, United States, 24301
- LewisGale Hospital - Pulaski
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Reston, Virginia, United States, 20190
- Reston Hospital
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Richmond, Virginia, United States, 23225
- CJW Medical Center (Chippenham & Johnston Willis Campuses)
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Richmond, Virginia, United States, 23229
- Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Facility Inclusion Criteria:
- HCA hospitals admitting adults for UTI
- Facility use of MEDITECH as their electronic health record system
Facility Exclusion Criteria:
-
Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Routine Care
Continued routine antibiotic stewardship strategies.
|
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
|
Active Comparator: INSPIRE CPOE Smart Prompt
Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for UTI in non-ICU patients in the first 3 days of hospitalization.
|
Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having a UTI due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day
Time Frame: 15 month intervention
|
The summed number of different extended-spectrum antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission.
An empiric day is a day within the first three days of an admission.
|
15 month intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vancomycin Days of Antibacterial Therapy per Empiric Day
Time Frame: 15 month intervention
|
The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission). Note: this outcome is intended for the primary manuscript. |
15 month intervention
|
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day
Time Frame: 15 month intervention
|
The summed number of different antipseudomonal antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission. Note: this outcome is intended for the primary manuscript. |
15 month intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period
Time Frame: 15 month intervention
|
The summed number of different ES antibacterials received each day, measured repeatedly on or after 4 calendar days of admission and divided by the number of days from hospital day 4 through discharge. Note: this outcome is intended for a secondary manuscript. |
15 month intervention
|
Incidence of Hospital-Onset C. difficile
Time Frame: 15 month intervention
|
Hospital-onset C. difficile positive tests (specimen obtained) after 3 calendar days of admission during hospitalization. Note: this outcome is intended for a secondary manuscript. |
15 month intervention
|
Incidence of Hospital-Onset MDRO-Positive Cultures
Time Frame: 15 month intervention
|
Newly-detected hospital-onset MDRO-positive cultures (on or after 3 calendar days of admission). Includes total MDRO and specific MDRO subsets. Note: this outcome is intended for a secondary manuscript. |
15 month intervention
|
Antibacterial Escalations [Safety Outcome 1]
Time Frame: 15 month intervention
|
Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay Note: this outcome is intended for the primary manuscript.
|
15 month intervention
|
ICU Transfers [Safety Outcome 2]
Time Frame: 15 month intervention
|
Days from start of hospitalization until ICU transfer within hospital stay Note: this outcome is intended for the primary manuscript.
|
15 month intervention
|
Length-of-stay [Safety Outcome 3]
Time Frame: 15 month intervention
|
Days from hospital admission to discharge.
Note: this outcome is intended for the primary manuscript.
|
15 month intervention
|
Empiric and Total Antibacterial Costs
Time Frame: 15 month intervention
|
Empiric and total antibacterial costs for UTI during hospitalization.
Note: this outcome is intended for a secondary manuscript.
|
15 month intervention
|
Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days
Time Frame: 15 month intervention
|
The summed number of different fluoroquinolone antibacterials received each day, measured repeatedly over (1) the first three days (empiric) of an admission and divided by the number of days of the admission) and (2) all days of an admission divided by the total number of admission days. Note: this outcome is intended for a secondary manuscript. |
15 month intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Platt, MD, MS, Harvard Pilgrim Health Care Institute
- Study Director: Shruti Gohil, MD, MPH, UC Irvine Div Infectious Diseases
- Principal Investigator: Susan Huang, MD, MPH, UC Irvine Div Infectious Diseases
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH000619B_UTI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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