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Trial record 59 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

The INSPIRE-ASP UTI Trial

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ClinicalTrials.gov Identifier: NCT03697096
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
Hospital Corporation of America Healthcare (HCA)
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infection (UTI) Other: Routine Care Other: INSPIRE CPOE Smart Prompt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI): The INSPIRE-ASP UTI Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Proportion of Days with Empiric Extended-Spectrum (ES) Antibacterial Treatment for UTI [ Time Frame: 15 month intervention ]

    Proportions of days with empiric ES antibacterial treatment for UTI per at-risk day, (first 3 days of admission).

    Note: this outcome is intended for the primary manuscript.



Secondary Outcome Measures :
  1. Proportion of Days with Empiric Vancomycin Treatment for UTI [ Time Frame: 15 month intervention ]

    Proportion of days with empiric Vancomycin treatment for UTI per at-risk-day (first 3 days of admission).

    Note: this outcome is intended for the primary manuscript.


  2. Proportion of Days with Empiric Antipseudomonal Treatment for UTI [ Time Frame: 15 month intervention ]

    Proportion of days with empiric antipseudomonal antibacterial treatment for UTI per at-risk-day (first 3 days of admission).

    Note: this outcome is intended for the primary manuscript.



Other Outcome Measures:
  1. Days from Start of Standard-Spectrum Until Switch to Extended-Spectrum Antibacterial for UTI [ Time Frame: 15 month intervention ]

    Safety Outcome 1: Days from start of standard-spectrum antibacterial for UTI until switch to extended-spectrum antibacterial for UTI during hospital stay.

    Note: this outcome is intended for the primary manuscript.


  2. Days from Start of Hospitalization Until ICU transfer Within Hospital Stay [ Time Frame: 15 month intervention ]

    Safety Outcome 2: Days from start of hospitalization until ICU transfer within hospital stay.

    Note: this outcome is intended for the primary manuscript.


  3. Length of Stay [ Time Frame: 15 month intervention ]
    Safety Outcome 3: Days from hospital admission to discharge. Note: this outcome is intended for the primary manuscript.

  4. Proportions of Days with Inpatient Extended-Spectrum (ES) Antibacterial Treatment for UTI After Empiric Period [ Time Frame: 15 month intervention ]

    Proportions of days with inpatient ES antibacterial treatment for UTI on or after 4 calendar days of admission per at-risk day (hospital day 4 through discharge).

    Note: this outcome is intended for a secondary manuscript.


  5. Empiric and Total Antibacterial Costs for UTI During Hospitalization [ Time Frame: 15 month intervention ]
    Empiric and total antibacterial costs for UTI during hospitalization. Note: this outcome is intended for a secondary manuscript.

  6. Incidence of Hospital-Onset C. difficile [ Time Frame: 15 month intervention ]

    Hospital-onset C. difficile positive tests (on or after 3 calendar days of admission) per at-risk day.

    Note: this outcome is intended for a secondary manuscript.


  7. 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) per at-risk day. Includes total MDRO and specific MDRO subsets.

    Note: this outcome is intended for a secondary manuscript.


  8. Proportion of Days with Empiric and Total Fluoroquinolone (FQ) Treatment for UTI [ Time Frame: 15 month intervention ]

    Proportion of days with empiric (within 3 days of admission) and total FQ treatment for UTI per at-risk day.

    Note: this outcome is intended for a secondary manuscript.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697096


Contacts
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Contact: Micaela Coady, MS 617-867-4880 micaela_coady@hphc.org
Contact: Shruti K Gohil, MD, MPH 347-675-0571 skgohil@uci.edu

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Sponsors and Collaborators
Harvard Pilgrim Health Care
Hospital Corporation of America Healthcare (HCA)
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Investigators
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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

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Responsible Party: Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT03697096     History of Changes
Other Study ID Numbers: PH000619B_UTI
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
UTI
CPOE
Empiric Therapy

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents