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Antibiotic Stewardship
Smart Prompt System vs Routine Care for Urinary Tract Infection
N/A
Waitlist Available
Led By Susan Huang, MD, MPH
Research Sponsored by Harvard Pilgrim Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 month intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effects of two different methods of treating UTIs in adults. One method is the standard antibiotic stewardship practices, and the other is a real-time precision medicine computerized physician order entry smart prompts.
Who is the study for?
The INSPIRE-ASP UTI Trial is for HCA hospitals that use MEDITECH electronic health record systems and admit non-critically ill adults with urinary tract infections. Individual patients are not directly enrolled; instead, the trial involves 59 hospitals.
What is being tested?
This trial compares usual antibiotic stewardship practices against a new approach using smart prompts in the hospital's computerized order entry system to predict resistance to antibiotics in adult UTI patients.
What are the potential side effects?
Since this trial focuses on hospital practices rather than direct patient interventions, it does not involve side effects in the traditional sense of medication or treatment-related adverse events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 month intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 month intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day
Secondary study objectives
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day
Vancomycin Days of Antibacterial Therapy per Empiric Day
Other study objectives
Antibacterial Escalations [Safety Outcome 1]
Empiric and Total Antibacterial Costs
Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: INSPIRE CPOE Smart PromptActive Control1 Intervention
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.
Group II: Routine CareActive Control1 Intervention
Continued routine antibiotic stewardship strategies.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,207 Total Patients Enrolled
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,703 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
208 Patients Enrolled for Urinary Tract Infection
University of California, IrvineOTHER
566 Previous Clinical Trials
1,932,989 Total Patients Enrolled
University of Massachusetts, AmherstOTHER
81 Previous Clinical Trials
468,091 Total Patients Enrolled
Harvard Pilgrim Health CareLead Sponsor
59 Previous Clinical Trials
24,986,042 Total Patients Enrolled
Hospital Corporation of America Healthcare (HCA)UNKNOWN
1 Previous Clinical Trials
59 Total Patients Enrolled
Susan Huang, MD, MPHPrincipal InvestigatorUC Irvine Div Infectious Diseases
7 Previous Clinical Trials
356,421 Total Patients Enrolled
Richard Platt, MD, MSPrincipal Investigator - Harvard Pilgrim Health Care Institute
Harvard Pilgrim Health Care
7 Previous Clinical Trials
6,427,924 Total Patients Enrolled
Shruti Gohil, MD, MPHStudy DirectorUC Irvine Div Infectious Diseases
3 Previous Clinical Trials
263 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The healthcare facility uses MEDITECH as their electronic health record system.The clinical trial is focused on adults who have been admitted to HCA hospitals with a urinary tract infection.I'm sorry, but the term "Facility" on its own is not specific enough for me to provide a simplified explanation. If you can provide more context or details about the specific criterion you are referring to, I'd be happy to help.
Research Study Groups:
This trial has the following groups:- Group 1: INSPIRE CPOE Smart Prompt
- Group 2: Routine Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Urinary Tract Infection Patient Testimony for trial: Trial Name: NCT03697096 — N/A