Clinical trial NCT03697096: The INSPIRE-ASP UTI Trial
Official title: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection (UTI)
Keywords: UTI
CPOE
Empiric Therapy
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Hospital Corporation of America
name: University of California, Irvine
name: University of Massachusetts, Amherst
name: Brigham and Women's Hospital
name: Centers for Disease Control and Prevention
First posted: 2018-10-05
Enrollment: 55412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Primary purpose: OTHER

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.


Eligibility 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. Prisoners were excluded from prompts and analysis.

Primary outcomes:
measure: Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day
timeFrame: First 3 days of hospitalization for each patient during 15-month intervention period
Secondary outcomes:
measure: Vancomycin Days of Antibacterial Therapy Per Empiric Day
timeFrame: First 3 days of hospitalization for each patient during 15-month intervention period
measure: Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
timeFrame: First 3 days of hospitalization for each patient during 15-month intervention period
Other outcomes:
measure: Antibacterial Escalations [Safety Outcome 1]
timeFrame: 15 month intervention
measure: ICU Transfers [Safety Outcome 2]
timeFrame: 15 month intervention
measure: Length-of-stay [Safety Outcome 3]
timeFrame: 15 month intervention
measure: Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibacterial Treatment After Empiric Period
timeFrame: 15 month intervention
measure: Empiric and Total Antibacterial Costs
timeFrame: 15 month intervention
measure: Incidence of Hospital-Onset C. Difficile
timeFrame: 15 month intervention
measure: Incidence of Hospital-Onset MDRO-Positive Cultures
timeFrame: 15 month intervention
measure: Fluoroquinolone (FQ) Days of Therapy Per Empiric and Total At-risk Days
timeFrame: 15 month intervention
Locations:
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Center of San Jose
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Denver
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Brandon
country: United States
facility: Brandon Hospital
state: Florida
city: Fort Walton Beach
country: United States
facility: Fort Walton Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Poinciana Medical Center
state: Florida
city: Lake City
country: United States
facility: Lake City Medical Center
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Margate
country: United States
facility: Northwest Medical Center
state: Florida
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
city: Niceville
country: United States
facility: Twin Cities Hospital
state: Florida
city: Palatka
country: United States
facility: Putnam Community Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Medical Center
state: Florida
city: Plantation
country: United States
facility: Westside Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: St. Lucie Medical Center
state: Florida
city: Sanford
country: United States
facility: Central Florida Regional Hospital
state: Florida
city: Sarasota
country: United States
facility: Doctor's Hospital Sarasota
state: Florida
city: Tallahassee
country: United States
facility: Capital Regional Medical Center
state: Florida
city: Trinity
country: United States
facility: Medical Center of Trinity
state: Florida
city: Cartersville
country: United States
facility: Cartersville Medical Center
state: Georgia
city: Dublin
country: United States
facility: Fairview Park
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Caldwell
country: United States
facility: West Valley Medical Center
state: Idaho
city: Terre Haute
country: United States
facility: Terre Haute Regional Hospital
state: Indiana
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Southern Hills Hospital - Vegas
state: Nevada
city: Dickson
country: United States
facility: TriStar Horizon Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Stonecrest Medical Center
state: Tennessee
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Brownsville
country: United States
facility: Valley Regional Medical Center
state: Texas
city: Conroe
country: United States
facility: Conroe Regional Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
state: Texas
city: Denton
country: United States
facility: Medical City Denton
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Houston
country: United States
facility: West Houston Medical Center
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Hospital
state: Texas
city: Pasadena
country: United States
facility: Bayshore Medical Center
state: Texas
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: Round Rock
country: United States
facility: Round Rock Hospital
state: Texas
city: San Antonio
country: United States
facility: Metropolitan Methodist Hospital
state: Texas
city: Webster
country: United States
facility: Clearlake Regional Medical Center
state: Texas
city: Blacksburg
country: United States
facility: LewisGale Hospital - Montgomery
state: Virginia
city: Hopewell
country: United States
facility: John Randolph Medical Center
state: Virginia
city: Pulaski
country: United States
facility: LewisGale Hospital - Pulaski
state: Virginia
city: Reston
country: United States
facility: Reston Hospital
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Chippenham & Johnston Willis Campuses)
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
state: Virginia
Study officials:
affiliation: UC Irvine Div Infectious Diseases
name: Shruti Gohil, MD, MPH
role: STUDY_DIRECTOR
affiliation: UC Irvine Div Infectious Diseases
name: Susan Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Pilgrim Health Care Institute
name: Richard Platt, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.