The INSPIRE-ASP UTI Trial
INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)
1 other identifier
interventional
55,412
1 country
59
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2024
CompletedResults Posted
Study results publicly available
January 30, 2025
CompletedJanuary 30, 2025
December 1, 2024
5.6 years
October 3, 2018
May 16, 2024
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day
The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
First 3 days of hospitalization for each patient during 15-month intervention period
Secondary Outcomes (2)
Vancomycin Days of Antibacterial Therapy Per Empiric Day
First 3 days of hospitalization for each patient during 15-month intervention period
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
First 3 days of hospitalization for each patient during 15-month intervention period
Other Outcomes (8)
Antibacterial Escalations [Safety Outcome 1]
15 month intervention
ICU Transfers [Safety Outcome 2]
15 month intervention
Length-of-stay [Safety Outcome 3]
15 month intervention
- +5 more other outcomes
Study Arms (2)
Routine Care
ACTIVE COMPARATORContinued routine antibiotic stewardship strategies.
INSPIRE CPOE Smart Prompt
ACTIVE COMPARATORUse 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.
Interventions
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
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.
Eligibility Criteria
You may qualify if:
- HCA hospitals admitting adults for UTI
- Facility use of MEDITECH as their electronic health record system
You may not qualify if:
- 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. Prisoners were excluded from prompts and analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard Pilgrim Health Carelead
- Hospital Corporation of Americacollaborator
- University of California, Irvinecollaborator
- University of Massachusetts, Amherstcollaborator
- Brigham and Women's Hospitalcollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (59)
Riverside Community Hospital
Riverside, California, 92501, United States
Regional Medical Center of San Jose
San Jose, California, 95116, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Swedish Medical Center
Denver, Colorado, 80113, United States
Sky Ridge Medical Center
Denver, Colorado, 80124, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Brandon Hospital
Brandon, Florida, 33511, United States
Fort Walton Medical Center
Fort Walton Beach, Florida, 32547, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Poinciana Medical Center
Kissimmee, Florida, 34758, United States
Lake City Medical Center
Lake City, Florida, 32055, United States
Largo Medical Center
Largo, Florida, 33770, United States
Northwest Medical Center
Margate, Florida, 33063, United States
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Twin Cities Hospital
Niceville, Florida, 32578, United States
Putnam Community Medical Center
Palatka, Florida, 80218, United States
Gulf Coast Medical Center
Panama City, Florida, 32405, United States
Westside Regional Medical Center
Plantation, Florida, 33324, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952, United States
Central Florida Regional Hospital
Sanford, Florida, 32771, United States
Doctor's Hospital Sarasota
Sarasota, Florida, 34233, United States
Capital Regional Medical Center
Tallahassee, Florida, 32308, United States
Medical Center of Trinity
Trinity, Florida, 34655, United States
Cartersville Medical Center
Cartersville, Georgia, 30120, United States
Fairview Park
Dublin, Georgia, 31021, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
West Valley Medical Center
Caldwell, Idaho, 83605, United States
Terre Haute Regional Hospital
Terre Haute, Indiana, 47802, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112, United States
Centerpoint Medical Center
Independence, Missouri, 64057, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Southern Hills Hospital - Vegas
Las Vegas, Nevada, 89148, United States
TriStar Horizon Medical Center
Dickson, Tennessee, 37055, United States
Stonecrest Medical Center
Nashville, Tennessee, 37167, United States
South Austin Hospital
Austin, Texas, 78704, United States
St. David's Medical Center
Austin, Texas, 78705, United States
Valley Regional Medical Center
Brownsville, Texas, 78526, United States
Conroe Regional Medical Center
Conroe, Texas, 77304, United States
Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
Corpus Christi, Texas, 78411, United States
Medical City Denton
Denton, Texas, 76210, United States
Medical City Fort Worth
Fort Worth, Texas, 76104, United States
West Houston Medical Center
Houston, Texas, 77082, United States
Kingwood Medical Center
Kingwood, Texas, 77339, United States
Rio Grande Regional Hospital
McAllen, Texas, 78503, United States
North Hills Hospital
North Richland Hills, Texas, 76180, United States
Bayshore Medical Center
Pasadena, Texas, 77504, United States
Medical City Plano
Plano, Texas, 75075, United States
Round Rock Hospital
Round Rock, Texas, 78681, United States
Metropolitan Methodist Hospital
San Antonio, Texas, 78212, United States
Clearlake Regional Medical Center
Webster, Texas, 77598, United States
LewisGale Hospital - Montgomery
Blacksburg, Virginia, 24060, United States
John Randolph Medical Center
Hopewell, Virginia, 23860, United States
LewisGale Hospital - Pulaski
Pulaski, Virginia, 24301, United States
Reston Hospital
Reston, Virginia, 20190, United States
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, 23225, United States
Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
Richmond, Virginia, 23229, United States
Related Publications (1)
Gohil SK, Septimus E, Kleinman K, Varma N, Avery TR, Heim L, Rahm R, Cooper WS, Cooper M, McLean LE, Nickolay NG, Weinstein RA, Burgess LH, Coady MH, Rosen E, Sljivo S, Sands KE, Moody J, Vigeant J, Rashid S, Gilbert RF, Smith KN, Carver B, Poland RE, Hickok J, Sturdevant SG, Calderwood MS, Weiland A, Kubiak DW, Reddy S, Neuhauser MM, Srinivasan A, Jernigan JA, Hayden MK, Gowda A, Eibensteiner K, Wolf R, Perlin JB, Platt R, Huang SS. Stewardship Prompts to Improve Antibiotic Selection for Urinary Tract Infection: The INSPIRE Randomized Clinical Trial. JAMA. 2024 Jun 18;331(23):2018-2028. doi: 10.1001/jama.2024.6259.
PMID: 38639723RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
\[Not Specified\]
Results Point of Contact
- Title
- Dr. Shruti Gohil, MD, MPH
- Organization
- Division of Infectious Diseases, University of California Irvine School of Medicine
Study Officials
- STUDY DIRECTOR
Shruti Gohil, MD, MPH
UC Irvine Div Infectious Diseases
- PRINCIPAL INVESTIGATOR
Susan Huang, MD, MPH
UC Irvine Div Infectious Diseases
- PRINCIPAL INVESTIGATOR
Richard Platt, MD, MS
Harvard Pilgrim Health Care Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair, Department of Population Medicine
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 5, 2018
Study Start
October 1, 2018
Primary Completion
May 16, 2024
Study Completion
May 16, 2024
Last Updated
January 30, 2025
Results First Posted
January 30, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share