Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
55412 participants
INTERVENTIONAL
2018-10-01
2024-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
NCT06996301
Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
NCT03354598
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
NCT04020341
EHR-integrated rUTI Texting Platform
NCT06035601
Evaluating UTI Outcomes in at Risk Populations
NCT05385536
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Routine Care
Continued routine antibiotic stewardship strategies.
Routine Care
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
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.
INSPIRE CPOE Smart Prompt
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Routine Care
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
INSPIRE CPOE Smart Prompt
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Facility use of MEDITECH as their electronic health record system
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. Prisoners were excluded from prompts and analysis.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Corporation of America
INDUSTRY
University of California, Irvine
OTHER
University of Massachusetts, Amherst
OTHER
Brigham and Women's Hospital
OTHER
Centers for Disease Control and Prevention
FED
Harvard Pilgrim Health Care
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Richard Platt
Professor and Chair, Department of Population Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shruti Gohil, MD, MPH
Role: STUDY_DIRECTOR
UC Irvine Div Infectious Diseases
Susan Huang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UC Irvine Div Infectious Diseases
Richard Platt, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Harvard Pilgrim Health Care Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Riverside Community Hospital
Riverside, California, United States
Regional Medical Center of San Jose
San Jose, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Swedish Medical Center
Denver, Colorado, United States
Sky Ridge Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Brandon Hospital
Brandon, Florida, United States
Fort Walton Medical Center
Fort Walton Beach, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Poinciana Medical Center
Kissimmee, Florida, United States
Lake City Medical Center
Lake City, Florida, United States
Largo Medical Center
Largo, Florida, United States
Northwest Medical Center
Margate, Florida, United States
Kendall Regional Medical Center
Miami, Florida, United States
Twin Cities Hospital
Niceville, Florida, United States
Putnam Community Medical Center
Palatka, Florida, United States
Gulf Coast Medical Center
Panama City, Florida, United States
Westside Regional Medical Center
Plantation, Florida, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, United States
Central Florida Regional Hospital
Sanford, Florida, United States
Doctor's Hospital Sarasota
Sarasota, Florida, United States
Capital Regional Medical Center
Tallahassee, Florida, United States
Medical Center of Trinity
Trinity, Florida, United States
Cartersville Medical Center
Cartersville, Georgia, United States
Fairview Park
Dublin, Georgia, United States
Redmond Regional Medical Center
Rome, Georgia, United States
West Valley Medical Center
Caldwell, Idaho, United States
Terre Haute Regional Hospital
Terre Haute, Indiana, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Southern Hills Hospital - Vegas
Las Vegas, Nevada, United States
TriStar Horizon Medical Center
Dickson, Tennessee, United States
Stonecrest Medical Center
Nashville, Tennessee, United States
South Austin Hospital
Austin, Texas, United States
St. David's Medical Center
Austin, Texas, United States
Valley Regional Medical Center
Brownsville, Texas, United States
Conroe Regional Medical Center
Conroe, Texas, United States
Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
Corpus Christi, Texas, United States
Medical City Denton
Denton, Texas, United States
Medical City Fort Worth
Fort Worth, Texas, United States
West Houston Medical Center
Houston, Texas, United States
Kingwood Medical Center
Kingwood, Texas, United States
Rio Grande Regional Hospital
McAllen, Texas, United States
North Hills Hospital
North Richland Hills, Texas, United States
Bayshore Medical Center
Pasadena, Texas, United States
Medical City Plano
Plano, Texas, United States
Round Rock Hospital
Round Rock, Texas, United States
Metropolitan Methodist Hospital
San Antonio, Texas, United States
Clearlake Regional Medical Center
Webster, Texas, United States
LewisGale Hospital - Montgomery
Blacksburg, Virginia, United States
John Randolph Medical Center
Hopewell, Virginia, United States
LewisGale Hospital - Pulaski
Pulaski, Virginia, United States
Reston Hospital
Reston, Virginia, United States
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, United States
Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PH000619B_UTI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.