The INSPIRE-ASP UTI Trial

Urinary Tract Infection (UTI) Clinical Trial

Official title:

INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI): The INSPIRE-ASP UTI Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03697096
• Other study ID #: PH000619B_UTI
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 a resistant pathogen.

Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infection (UTI)
• Urinary Tract Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The Medical Center of Aurora	Aurora	Colorado
United States	South Austin Hospital	Austin	Texas
United States	St. David's Medical Center	Austin	Texas
United States	LewisGale Hospital - Montgomery	Blacksburg	Virginia
United States	Brandon Hospital	Brandon	Florida
United States	Valley Regional Medical Center	Brownsville	Texas
United States	West Valley Medical Center	Caldwell	Idaho
United States	Cartersville Medical Center	Cartersville	Georgia
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	Rose Medical Center	Denver	Colorado
United States	Sky Ridge Medical Center	Denver	Colorado
United States	Swedish Medical Center	Denver	Colorado
United States	TriStar Horizon Medical Center	Dickson	Tennessee
United States	Fairview Park	Dublin	Georgia
United States	Fort Walton Medical Center	Fort Walton Beach	Florida
United States	Medical City Fort Worth	Fort Worth	Texas
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	John Randolph Medical Center	Hopewell	Virginia
United States	West Houston Medical Center	Houston	Texas
United States	Centerpoint Medical Center	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Kingwood Medical Center	Kingwood	Texas
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	Southern Hills Hospital - Vegas	Las Vegas	Nevada
United States	Northwest Medical Center	Margate	Florida
United States	Rio Grande Regional Hospital	McAllen	Texas
United States	Kendall Regional Medical Center	Miami	Florida
United States	Stonecrest Medical Center	Nashville	Tennessee
United States	Tulane University Hospital & Clinic	New Orleans	Louisiana
United States	Twin Cities Hospital	Niceville	Florida
United States	North Hills Hospital	North Richland Hills	Texas
United States	Putnam Community Medical Center	Palatka	Florida
United States	Gulf Coast Medical Center	Panama City	Florida
United States	Bayshore Medical Center	Pasadena	Texas
United States	Medical City Plano	Plano	Texas
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	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	Riverside Community Hospital	Riverside	California
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Round Rock Hospital	Round Rock	Texas
United States	Metropolitan Methodist Hospital	San Antonio	Texas
United States	Regional Medical Center of San Jose	San Jose	California
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	Terre Haute Regional Hospital	Terre Haute	Indiana
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Medical Center of Trinity	Trinity	Florida
United States	Clearlake Regional Medical Center	Webster	Texas

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibacterial Escalations [Safety Outcome 1]	Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay Note: this outcome is intended for the primary manuscript.	15 month intervention
Other	ICU Transfers [Safety Outcome 2]	Days from start of hospitalization until ICU transfer within hospital stay Note: this outcome is intended for the primary manuscript.	15 month intervention
Other	Length-of-stay [Safety Outcome 3]	Days from hospital admission to discharge. Note: this outcome is intended for the primary manuscript.	15 month intervention
Other	Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period	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
Other	Empiric and Total Antibacterial Costs	Empiric and total antibacterial costs for UTI during hospitalization. Note: this outcome is intended for a secondary manuscript.	15 month intervention
Other	Incidence of Hospital-Onset C. difficile	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
Other	Incidence of Hospital-Onset MDRO-Positive Cultures	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
Other	Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days	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
Primary	Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day	The summed number of different extended-spectrum antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission.	15 month intervention
Secondary	Vancomycin Days of Antibacterial Therapy per Empiric Day	The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission).; Note: this outcome is intended for the primary manuscript.	15 month intervention
Secondary	Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day	The summed number of different antipseudomonal antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission.; Note: this outcome is intended for the primary manuscript.	15 month intervention