The INSPIRE-ASP UTI Trial

Sponsor

Harvard Pilgrim Health Care (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03697096

Collaborator

Hospital Corporation of America Healthcare (HCA) (Other), University of California, Irvine (Other), University of Massachusetts, Amherst (Other), Brigham and Women's Hospital (Other), Centers for Disease Control and Prevention (U.S. Fed)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection (UTI)	Other: Routine Care Other: INSPIRE CPOE Smart Prompt	N/A

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Oct 1, 2018

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day [15 month intervention]
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 [15 month intervention]
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 [15 month intervention]
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.

Other Outcome Measures

Antibacterial Escalations [Safety Outcome 1] [15 month intervention]
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.
ICU Transfers [Safety Outcome 2] [15 month intervention]
Days from start of hospitalization until ICU transfer within hospital stay Note: this outcome is intended for the primary manuscript.
Length-of-stay [Safety Outcome 3] [15 month intervention]
Days from hospital admission to discharge. Note: this outcome is intended for the primary manuscript.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside Community Hospital	Riverside	California	United States	92501
2	Regional Medical Center of San Jose	San Jose	California	United States	95116
3	Los Robles Regional Medical Center	Thousand Oaks	California	United States	91360
4	The Medical Center of Aurora	Aurora	Colorado	United States	80012
5	Swedish Medical Center	Denver	Colorado	United States	80113
6	Sky Ridge Medical Center	Denver	Colorado	United States	80124
7	Rose Medical Center	Denver	Colorado	United States	80220
8	Brandon Hospital	Brandon	Florida	United States	33511
9	Fort Walton Medical Center	Fort Walton Beach	Florida	United States	32547
10	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
11	Osceola Regional Medical Center	Kissimmee	Florida	United States	34741
12	Poinciana Medical Center	Kissimmee	Florida	United States	34758
13	Lake City Medical Center	Lake City	Florida	United States	32055
14	Largo Medical Center	Largo	Florida	United States	33770
15	Northwest Medical Center	Margate	Florida	United States	33063
16	Kendall Regional Medical Center	Miami	Florida	United States	33175
17	Twin Cities Hospital	Niceville	Florida	United States	32578
18	Putnam Community Medical Center	Palatka	Florida	United States	80218
19	Gulf Coast Medical Center	Panama City	Florida	United States	32405
20	Westside Regional Medical Center	Plantation	Florida	United States	33324
21	Fawcett Memorial Hospital	Port Charlotte	Florida	United States	33952
22	St. Lucie Medical Center	Port Saint Lucie	Florida	United States	34952
23	Central Florida Regional Hospital	Sanford	Florida	United States	32771
24	Doctor's Hospital Sarasota	Sarasota	Florida	United States	34233
25	Capital Regional Medical Center	Tallahassee	Florida	United States	32308
26	Medical Center of Trinity	Trinity	Florida	United States	34655
27	Cartersville Medical Center	Cartersville	Georgia	United States	30120
28	Fairview Park	Dublin	Georgia	United States	31021
29	Redmond Regional Medical Center	Rome	Georgia	United States	30165
30	West Valley Medical Center	Caldwell	Idaho	United States	83605
31	Terre Haute Regional Hospital	Terre Haute	Indiana	United States	47802
32	Tulane University Hospital & Clinic	New Orleans	Louisiana	United States	70112
33	Centerpoint Medical Center	Independence	Missouri	United States	64057
34	Research Medical Center	Kansas City	Missouri	United States	64132
35	Southern Hills Hospital - Vegas	Las Vegas	Nevada	United States	89148
36	TriStar Horizon Medical Center	Dickson	Tennessee	United States	37055
37	Stonecrest Medical Center	Nashville	Tennessee	United States	37167
38	South Austin Hospital	Austin	Texas	United States	78704
39	St. David's Medical Center	Austin	Texas	United States	78705
40	Valley Regional Medical Center	Brownsville	Texas	United States	78526
41	Conroe Regional Medical Center	Conroe	Texas	United States	77304
42	Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)	Corpus Christi	Texas	United States	78411
43	Medical City Denton	Denton	Texas	United States	76210
44	Medical City Fort Worth	Fort Worth	Texas	United States	76104
45	West Houston Medical Center	Houston	Texas	United States	77082
46	Kingwood Medical Center	Kingwood	Texas	United States	77339
47	Rio Grande Regional Hospital	McAllen	Texas	United States	78503
48	North Hills Hospital	North Richland Hills	Texas	United States	76180
49	Bayshore Medical Center	Pasadena	Texas	United States	77504
50	Medical City Plano	Plano	Texas	United States	75075
51	Round Rock Hospital	Round Rock	Texas	United States	78681
52	Metropolitan Methodist Hospital	San Antonio	Texas	United States	78212
53	Clearlake Regional Medical Center	Webster	Texas	United States	77598
54	LewisGale Hospital - Montgomery	Blacksburg	Virginia	United States	24060
55	John Randolph Medical Center	Hopewell	Virginia	United States	23860
56	LewisGale Hospital - Pulaski	Pulaski	Virginia	United States	24301
57	Reston Hospital	Reston	Virginia	United States	20190
58	CJW Medical Center (Chippenham & Johnston Willis Campuses)	Richmond	Virginia	United States	23225
59	Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)	Richmond	Virginia	United States	23229

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

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