Urinary Tract Infection (UTI)NCT03697096
The INSPIRE-ASP UTI Trial
A study testing Routine Care and INSPIRE CPOE Smart Prompt in people with Urinary Tract Infection (UTI), run by Harvard Pilgrim Health Care at 59 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection (UTI)
- What is being tested?
- Routine Care and INSPIRE CPOE Smart Prompt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55,412 participants
- Where
- 59 sitesUnited States
- Study dates
- 1 Oct 2018to 16 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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. Prisoners were excluded from prompts and analysis.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
The Medical Center of Aurora
Aurora, Colorado, 80012
South Austin Hospital
Austin, Texas, 78704
St. David's Medical Center
Austin, Texas, 78705
LewisGale Hospital - Montgomery
Blacksburg, Virginia, 24060
Brandon Hospital
Brandon, Florida, 33511
Valley Regional Medical Center
Brownsville, Texas, 78526
West Valley Medical Center
Caldwell, Idaho, 83605
Cartersville Medical Center
Cartersville, Georgia, 30120
Conroe Regional Medical Center
Conroe, Texas, 77304
Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
Corpus Christi, Texas, 78411
Medical City Denton
Denton, Texas, 76210
Swedish Medical Center
Denver, Colorado, 80113
Sky Ridge Medical Center
Denver, Colorado, 80124
Rose Medical Center
Denver, Colorado, 80220
TriStar Horizon Medical Center
Dickson, Tennessee, 37055
Fairview Park
Dublin, Georgia, 31021
Fort Walton Medical Center
Fort Walton Beach, Florida, 32547
Medical City Fort Worth
Fort Worth, Texas, 76104
North Florida Regional Medical Center
Gainesville, Florida, 32605
John Randolph Medical Center
Hopewell, Virginia, 23860
West Houston Medical Center
Houston, Texas, 77082
Centerpoint Medical Center
Independence, Missouri, 64057
Research Medical Center
Kansas City, Missouri, 64132
Kingwood Medical Center
Kingwood, Texas, 77339
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Poinciana Medical Center
Kissimmee, Florida, 34758
Lake City Medical Center
Lake City, Florida, 32055
Largo Medical Center
Largo, Florida, 33770
Southern Hills Hospital - Vegas
Las Vegas, Nevada, 89148
Northwest Medical Center
Margate, Florida, 33063
Rio Grande Regional Hospital
McAllen, Texas, 78503
Kendall Regional Medical Center
Miami, Florida, 33175
Stonecrest Medical Center
Nashville, Tennessee, 37167
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112
Twin Cities Hospital
Niceville, Florida, 32578
North Hills Hospital
North Richland Hills, Texas, 76180
Putnam Community Medical Center
Palatka, Florida, 80218
Gulf Coast Medical Center
Panama City, Florida, 32405
Bayshore Medical Center
Pasadena, Texas, 77504
Medical City Plano
Plano, Texas, 75075
Westside Regional Medical Center
Plantation, Florida, 33324
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952
LewisGale Hospital - Pulaski
Pulaski, Virginia, 24301
Reston Hospital
Reston, Virginia, 20190
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, 23225
Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
Richmond, Virginia, 23229
Riverside Community Hospital
Riverside, California, 92501
Redmond Regional Medical Center
Rome, Georgia, 30165
Round Rock Hospital
Round Rock, Texas, 78681
Metropolitan Methodist Hospital
San Antonio, Texas, 78212
Regional Medical Center of San Jose
San Jose, California, 95116
Central Florida Regional Hospital
Sanford, Florida, 32771
Doctor's Hospital Sarasota
Sarasota, Florida, 34233
Capital Regional Medical Center
Tallahassee, Florida, 32308
Terre Haute Regional Hospital
Terre Haute, Indiana, 47802
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Medical Center of Trinity
Trinity, Florida, 34655
Clearlake Regional Medical Center
Webster, Texas, 77598
About this study
Official title: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)
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.
- Conditions
- Urinary Tract Infection (UTI)
- Being tested
- Routine Care, INSPIRE CPOE Smart Prompt
- Keywords
- UTI, CPOE, Empiric Therapy
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareOther
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
INSPIRE CPOE Smart PromptOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Active comparator | Continued routine antibiotic stewardship strategies. Receives: Other: Routine Care |
| INSPIRE CPOE Smart Prompt | Active comparator | 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. Receives: Other: INSPIRE CPOE Smart Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 3 days of hospitalization for each patient during 15-month intervention period
Secondary outcomes (2)
Vancomycin Days of Antibacterial Therapy Per Empiric Day
The number of days that Vancomycin is received by the patient 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.
Measured: First 3 days of hospitalization for each patient during 15-month intervention period
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
The number of different antipseudomonals received by the patient each empiric day of therapy, 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.
Measured: First 3 days of hospitalization for each patient during 15-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Oct 2018
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection (UTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
- Masking
- None (open label)
- Enrolment
- 55,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Corporation of America, University of California, Irvine, University of Massachusetts, Amherst, Brigham and Women's Hospital, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Richard Platt, Harvard Pilgrim Health Care
- Investigators
- Shruti Gohil, MD, MPH, Study director, UC Irvine Div Infectious DiseasesSusan Huang, MD, MPH, Principal investigator, UC Irvine Div Infectious DiseasesRichard Platt, MD, MS, Principal investigator, Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697096
- Sponsor's protocol ID
- PH000619B_UTI
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2018
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38639723Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
PubMed 42268612
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)
- ClinicalTrials.gov ID
- NCT03697096
- Acronym / sponsor ID
- PH000619B_UTI
- Conditions
- Urinary Tract Infection (UTI)
- Keywords
- UTI, CPOE, Empiric Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55,412 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Hospital Corporation of America, University of California, Irvine, University of Massachusetts, Amherst, Brigham and Women's Hospital, Centers for Disease Control and Prevention
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Active comparator | Other: Routine CareContinued routine antibiotic stewardship strategies. |
| INSPIRE CPOE Smart Prompt | Active comparator | Other: INSPIRE CPOE Smart PromptUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine CareRoutine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards. | Other | Routine Care |
| INSPIRE CPOE Smart PromptQuality 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. | Other | INSPIRE CPOE Smart Prompt |
Primary outcome
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day
Time frame: First 3 days of hospitalization for each patient during 15-month intervention period
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.
2 secondary outcomes
Vancomycin Days of Antibacterial Therapy Per Empiric Day
Time frame: First 3 days of hospitalization for each patient during 15-month intervention period
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
Time frame: First 3 days of hospitalization for each patient during 15-month intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38639723Gohil 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.
- Derived from this study: PubMed 42268612Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shruti Gohil, MD, MPH study director
UC Irvine Div Infectious Diseases
Susan Huang, MD, MPH principal investigator
UC Irvine Div Infectious Diseases
Richard Platt, MD, MS principal investigator
Harvard Pilgrim Health Care Institute
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care and INSPIRE CPOE Smart Prompt in people with Urinary Tract Infection (UTI), run by Harvard Pilgrim Health Care at 59 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day (time frame: First 3 days of hospitalization for each patient during 15-month intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.