The INSPIRE-ASP UTI Trial

December 13, 2024 updated by: Richard Platt, Harvard Pilgrim Health Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • 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
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80113
        • Swedish Medical Center
      • Denver, Colorado, United States, 80124
        • Sky Ridge Medical Center
    • Florida
      • Brandon, Florida, United States, 33511
        • Brandon Hospital
      • 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
      • Lake City, Florida, United States, 32055
        • Lake City Medical Center
      • Largo, Florida, United States, 33770
        • Largo Medical Center
      • Margate, Florida, United States, 33063
        • Northwest Medical Center
      • Miami, Florida, United States, 33175
        • Kendall Regional Medical Center
      • Niceville, Florida, United States, 32578
        • Twin Cities Hospital
      • Palatka, Florida, United States, 80218
        • Putnam Community Medical Center
      • Panama City, Florida, United States, 32405
        • Gulf Coast Medical Center
      • Plantation, Florida, United States, 33324
        • Westside Regional Medical Center
      • Port Charlotte, Florida, United States, 33952
        • Fawcett Memorial Hospital
      • Port Saint Lucie, Florida, United States, 34952
        • St. Lucie Medical Center
      • Sanford, Florida, United States, 32771
        • Central Florida Regional Hospital
      • Sarasota, Florida, United States, 34233
        • Doctor's Hospital Sarasota
      • Tallahassee, Florida, United States, 32308
        • Capital Regional Medical Center
      • Trinity, Florida, United States, 34655
        • Medical Center of Trinity
    • Georgia
      • Cartersville, Georgia, United States, 30120
        • Cartersville Medical Center
      • Dublin, Georgia, United States, 31021
        • Fairview Park
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Idaho
      • Caldwell, Idaho, United States, 83605
        • West Valley Medical Center
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Terre Haute Regional Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital & Clinic
    • Missouri
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Southern Hills Hospital - Vegas
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • TriStar Horizon Medical Center
      • Nashville, Tennessee, United States, 37167
        • Stonecrest Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • St. David's Medical Center
      • Austin, Texas, United States, 78704
        • South Austin Hospital
      • Brownsville, Texas, United States, 78526
        • Valley Regional Medical Center
      • Conroe, Texas, United States, 77304
        • Conroe Regional Medical Center
      • Corpus Christi, Texas, United States, 78411
        • Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
      • Denton, Texas, United States, 76210
        • Medical City Denton
      • Fort Worth, Texas, United States, 76104
        • Medical City Fort Worth
      • Houston, Texas, United States, 77082
        • West Houston Medical Center
      • Kingwood, Texas, United States, 77339
        • Kingwood Medical Center
      • McAllen, Texas, United States, 78503
        • Rio Grande Regional Hospital
      • North Richland Hills, Texas, United States, 76180
        • North Hills Hospital
      • Pasadena, Texas, United States, 77504
        • Bayshore Medical Center
      • Plano, Texas, United States, 75075
        • Medical City Plano
      • Round Rock, Texas, United States, 78681
        • Round Rock Hospital
      • San Antonio, Texas, United States, 78212
        • Metropolitan Methodist Hospital
      • Webster, Texas, United States, 77598
        • Clearlake Regional Medical Center
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • LewisGale Hospital - Montgomery
      • Hopewell, Virginia, United States, 23860
        • John Randolph Medical Center
      • Pulaski, Virginia, United States, 24301
        • LewisGale Hospital - Pulaski
      • Reston, Virginia, United States, 20190
        • Reston Hospital
      • Richmond, Virginia, United States, 23225
        • CJW Medical Center (Chippenham & Johnston Willis Campuses)
      • Richmond, Virginia, United States, 23229
        • Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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. Prisoners were excluded from prompts and analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Routine Care
Continued routine antibiotic stewardship strategies.
Other: Routine Care
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
First 3 days of hospitalization for each patient during 15-month intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vancomycin Days of Antibacterial Therapy Per Empiric Day
Time Frame: First 3 days of hospitalization for each patient during 15-month intervention period
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.
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
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.
First 3 days of hospitalization for each patient during 15-month intervention period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.
15 month intervention
ICU Transfers [Safety Outcome 2]
Time Frame: 15 month intervention
Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.
15 month intervention
Length-of-stay [Safety Outcome 3]
Time Frame: 15 month intervention
Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard Pilgrim Health Care

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brigham and Women's Hospital
Centers for Disease Control and Prevention
University of California, Irvine
University of Massachusetts, Amherst
Hospital Corporation of America

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PH000619B_UTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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