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The INSPIRE-ASP UTI Trial

Primary Purpose

Urinary Tract Infection (UTI)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Care
INSPIRE CPOE Smart Prompt
Sponsored by
Harvard Pilgrim Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Tract Infection (UTI) focused on measuring UTI, CPOE, Empiric Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riverside Community Hospital
  • Regional Medical Center of San Jose
  • Los Robles Regional Medical Center
  • The Medical Center of Aurora
  • Swedish Medical Center
  • Sky Ridge Medical Center
  • Rose Medical Center
  • Brandon Hospital
  • Fort Walton Medical Center
  • North Florida Regional Medical Center
  • Osceola Regional Medical Center
  • Poinciana Medical Center
  • Lake City Medical Center
  • Largo Medical Center
  • Northwest Medical Center
  • Kendall Regional Medical Center
  • Twin Cities Hospital
  • Putnam Community Medical Center
  • Gulf Coast Medical Center
  • Westside Regional Medical Center
  • Fawcett Memorial Hospital
  • St. Lucie Medical Center
  • Central Florida Regional Hospital
  • Doctor's Hospital Sarasota
  • Capital Regional Medical Center
  • Medical Center of Trinity
  • Cartersville Medical Center
  • Fairview Park
  • Redmond Regional Medical Center
  • West Valley Medical Center
  • Terre Haute Regional Hospital
  • Tulane University Hospital & Clinic
  • Centerpoint Medical Center
  • Research Medical Center
  • Southern Hills Hospital - Vegas
  • TriStar Horizon Medical Center
  • Stonecrest Medical Center
  • South Austin Hospital
  • St. David's Medical Center
  • Valley Regional Medical Center
  • Conroe Regional Medical Center
  • Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
  • Medical City Denton
  • Medical City Fort Worth
  • West Houston Medical Center
  • Kingwood Medical Center
  • Rio Grande Regional Hospital
  • North Hills Hospital
  • Bayshore Medical Center
  • Medical City Plano
  • Round Rock Hospital
  • Metropolitan Methodist Hospital
  • Clearlake Regional Medical Center
  • LewisGale Hospital - Montgomery
  • John Randolph Medical Center
  • LewisGale Hospital - Pulaski
  • Reston Hospital
  • CJW Medical Center (Chippenham & Johnston Willis Campuses)
  • Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Routine Care

INSPIRE CPOE Smart Prompt

Arm Description

Continued routine antibiotic stewardship strategies.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 3, 2018
Last Updated
September 22, 2023
Sponsor
Harvard Pilgrim Health Care
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
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1. Study Identification

Unique Protocol Identification Number
NCT03697096
Brief Title
The INSPIRE-ASP UTI 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Pilgrim Health Care
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection (UTI)
Keywords
UTI, CPOE, Empiric Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Care
Arm Type
Active Comparator
Arm Description
Continued routine antibiotic stewardship strategies.
Arm Title
INSPIRE CPOE Smart Prompt
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
Intervention Type
Other
Intervention Name(s)
INSPIRE CPOE Smart Prompt
Intervention Description
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 Measure Information:
Title
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day
Description
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.
Time Frame
15 month intervention
Secondary Outcome Measure Information:
Title
Vancomycin Days of Antibacterial Therapy per Empiric Day
Description
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.
Time Frame
15 month intervention
Title
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day
Description
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.
Time Frame
15 month intervention
Other Pre-specified Outcome Measures:
Title
Antibacterial Escalations [Safety Outcome 1]
Description
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.
Time Frame
15 month intervention
Title
ICU Transfers [Safety Outcome 2]
Description
Days from start of hospitalization until ICU transfer within hospital stay Note: this outcome is intended for the primary manuscript.
Time Frame
15 month intervention
Title
Length-of-stay [Safety Outcome 3]
Description
Days from hospital admission to discharge. Note: this outcome is intended for the primary manuscript.
Time Frame
15 month intervention
Title
Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period
Description
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.
Time Frame
15 month intervention
Title
Empiric and Total Antibacterial Costs
Description
Empiric and total antibacterial costs for UTI during hospitalization. Note: this outcome is intended for a secondary manuscript.
Time Frame
15 month intervention
Title
Incidence of Hospital-Onset C. difficile
Description
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.
Time Frame
15 month intervention
Title
Incidence of Hospital-Onset MDRO-Positive Cultures
Description
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.
Time Frame
15 month intervention
Title
Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days
Description
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.
Time Frame
15 month intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shruti Gohil, MD, MPH
Organizational Affiliation
UC Irvine Div Infectious Diseases
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan Huang, MD, MPH
Organizational Affiliation
UC Irvine Div Infectious Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Platt, MD, MS
Organizational Affiliation
Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverside Community Hospital
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Regional Medical Center of San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Swedish Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Sky Ridge Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Brandon Hospital
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Fort Walton Medical Center
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Poinciana Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34758
Country
United States
Facility Name
Lake City Medical Center
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Largo Medical Center
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Northwest Medical Center
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Kendall Regional Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Twin Cities Hospital
City
Niceville
State/Province
Florida
ZIP/Postal Code
32578
Country
United States
Facility Name
Putnam Community Medical Center
City
Palatka
State/Province
Florida
ZIP/Postal Code
80218
Country
United States
Facility Name
Gulf Coast Medical Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Westside Regional Medical Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Fawcett Memorial Hospital
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
St. Lucie Medical Center
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Central Florida Regional Hospital
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Doctor's Hospital Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Capital Regional Medical Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Medical Center of Trinity
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Cartersville Medical Center
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Facility Name
Fairview Park
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Redmond Regional Medical Center
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
West Valley Medical Center
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Terre Haute Regional Hospital
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Tulane University Hospital & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Centerpoint Medical Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Southern Hills Hospital - Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
TriStar Horizon Medical Center
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Stonecrest Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
South Austin Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Valley Regional Medical Center
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
Conroe Regional Medical Center
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Denton
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Medical City Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
West Houston Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77082
Country
United States
Facility Name
Kingwood Medical Center
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Rio Grande Regional Hospital
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
North Hills Hospital
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Bayshore Medical Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Medical City Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Round Rock Hospital
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Metropolitan Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Clearlake Regional Medical Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
LewisGale Hospital - Montgomery
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
John Randolph Medical Center
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
Facility Name
LewisGale Hospital - Pulaski
City
Pulaski
State/Province
Virginia
ZIP/Postal Code
24301
Country
United States
Facility Name
Reston Hospital
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
CJW Medical Center (Chippenham & Johnston Willis Campuses)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States

12. IPD Sharing Statement

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The INSPIRE-ASP UTI Trial

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