The INSPIRE-ASP UTI Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03697096

Enrollment

55412

Registered

2018-10-05

Start date

2018-10-01

Completion date

2024-05-16

Last updated

2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection (UTI)

Keywords

UTI, CPOE, Empiric Therapy

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.

Interventions

OTHERRoutine Care

Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.

OTHERINSPIRE 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day	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.

Secondary

Measure	Time frame	Description
Vancomycin Days of Antibacterial Therapy Per Empiric Day	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.
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	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.

Other

Measure	Time frame	Description
Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibacterial Treatment After Empiric Period	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.
Empiric and Total Antibacterial Costs	15 month intervention	Empiric and total antibacterial costs for UTI during hospitalization. Note: this outcome is intended for a secondary manuscript.
Antibacterial Escalations [Safety Outcome 1]	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.
Incidence of Hospital-Onset MDRO-Positive Cultures	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.
Fluoroquinolone (FQ) Days of Therapy Per Empiric and Total At-risk Days	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.
Incidence of Hospital-Onset C. Difficile	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.
ICU Transfers [Safety Outcome 2]	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.
Length-of-stay [Safety Outcome 3]	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.

Countries

United States

Participant flow

Recruitment details

59 out of 143 HCA Healthcare hospitals were recruited for this trial. There was a 15 month intervention period from April 1, 2019 through June 30, 2020.

Pre-assignment details

55,412 patients were involved in the intervention period from the 59 participating hospitals.

Participants by arm

Arm	Count
Arm 1: Routine Care Continued routine antibiotic stewardship strategies. Routine Care: Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.	27,505
Arm 2: CPOE Bundle 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. 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.	27,907
Total	55,412

Baseline characteristics

Characteristic	Arm 1: Routine Care	Arm 2: CPOE Bundle	Total
Age, Continuous	69.5 years STANDARD_DEVIATION 17.7	69.5 years STANDARD_DEVIATION 17.8	69.5 years STANDARD_DEVIATION 17.8
Race/Ethnicity, Customized Race Black	3314 Participants	3455 Participants	6769 Participants
Race/Ethnicity, Customized Race Other	901 Participants	1357 Participants	2258 Participants
Race/Ethnicity, Customized Race White	19477 Participants	21352 Participants	40829 Participants
Sex: Female, Male Female	19013 Participants	19040 Participants	38053 Participants
Sex: Female, Male Male	8398 Participants	8793 Participants	17191 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27,505	0 / 27,907
other Total, other adverse events	0 / 27,505	0 / 27,907
serious Total, serious adverse events	0 / 27,505	0 / 27,907

Outcome results

Primary

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.

Time frame: First 3 days of hospitalization for each patient during 15-month intervention period

Population: The total number of participants analyzed reported here is from the intervention period.

Arm	Measure	Value (NUMBER)
Arm 1: Routine Stewardship	Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day	35023 Extended-Spectrum Days-of-Therapy
Arm 2: CPOE Bundle	Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day	25987 Extended-Spectrum Days-of-Therapy

Secondary

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.

Time frame: First 3 days of hospitalization for each patient during 15-month intervention period

Population: The total number of participants analyzed reported here is from the intervention period.

Arm	Measure	Value (NUMBER)
Arm 1: Routine Stewardship	Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	20792 Antipseudomonal Days-of-Therapy
Arm 2: CPOE Bundle	Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	14186 Antipseudomonal Days-of-Therapy

Secondary

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.

Time frame: First 3 days of hospitalization for each patient during 15-month intervention period

Population: The total number of participants analyzed reported here is from the intervention period.

Arm	Measure	Value (NUMBER)
Arm 1: Routine Stewardship	Vancomycin Days of Antibacterial Therapy Per Empiric Day	9795 Vancomycin Days-of-Therapy
Arm 2: CPOE Bundle	Vancomycin Days of Antibacterial Therapy Per Empiric Day	8071 Vancomycin Days-of-Therapy

Other Pre-specified

Antibacterial Escalations [Safety Outcome 1]

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.