The INSPIRE-ASP UTI Trial

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Richard Platt，Harvard Pilgrim Health Care

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Empiric Extended-Spectrum (ES) Antibacterial Use[ Time Frame: 15 month intervention ]

Days of empiric ES antibacterial treatment for UTI per at-risk day, (first 3 days of admission). Note: this outcome is intended for the primary manuscript.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Empiric Vancomycin Use[ Time Frame: 15 month intervention ]
Days of empiric Vancomycin treatment for UTI per at-risk day (first 3 days of admission). Note: this outcome is intended for the primary manuscript.
Empiric Antipseudomonal Use[ Time Frame: 15 month intervention ]
Days of empiric antipseudomonal antibacterial treatment for UTI per at-risk day (first 3 days of admission). Note: this outcome is intended for the primary manuscript.

Descriptive Information

Brief Title ^ICMJE

The INSPIRE-ASP UTI Trial

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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.
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Active Comparator: Routine Care
Continued routine antibiotic stewardship strategies.
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 the first 3 days of hospitalization.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2024

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: Facility inclusion criteria includes HCA hospitals admitting adults for UTI and use MEDITECH as their electronic health record system. 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. Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Richard Platt，Harvard Pilgrim Health Care

Study Sponsor ^ICMJE

Harvard Pilgrim Health Care

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Harvard Pilgrim Health Care

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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