Smart Prompt System vs Routine Care for Urinary Tract Infection

No longer recruiting at 58 trial locations

Overseen By Shruti K Gohil, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

Must be taking: Extended-spectrum antibiotics

Disqualifiers: Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how hospitals select antibiotics for urinary tract infections (UTIs) by comparing two methods. One group of hospitals will use a smart prompt system (INSPIRE CPOE Smart Prompt) to help doctors choose the right antibiotics based on the likelihood of a patient having a resistant infection. The other group will continue with current practices. Adults in hospitals with non-severe UTIs, who are not in intensive care and are prescribed broad antibiotics, might be suitable for this trial. As an unphased trial, this study allows participants to contribute to innovative approaches in antibiotic selection, potentially enhancing future treatment outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the INSPIRE CPOE Smart Prompt is safe for use in hospitals?

Research has shown that the INSPIRE CPOE Smart Prompt system is safe to use. This computer tool assists doctors in selecting the appropriate antibiotics for urinary tract infections (UTIs). Studies have found that it improves antibiotic selection without causing additional harm to patients, indicating it is well-tolerated and does not lead to more side effects than usual care.

The system has been tested in various situations, including other types of infections, and has performed well. No reports indicate the system itself causes harm or negative effects. Instead, it aids doctors in making better choices, potentially leading to improved patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE CPOE Smart Prompt because it introduces a computerized alert system to help doctors choose antibiotics for urinary tract infections (UTIs) more effectively in the first three days of hospitalization. Unlike standard UTI treatments that rely on routine antibiotic stewardship, this smart prompt is designed to guide decisions more precisely, potentially improving treatment efficiency and patient outcomes. By offering timely, data-driven insights, the system aims to enhance the accuracy of antibiotic selection, which could reduce overuse and resistance issues associated with current practices.

What evidence suggests that the INSPIRE CPOE Smart Prompt is effective for treating urinary tract infections?

Research has shown that the INSPIRE CPOE Smart Prompt, which participants in this trial may receive, helps doctors choose better antibiotics for urinary tract infections (UTIs). Studies have found that this tool reduces unnecessary antibiotic use, which is crucial for preventing drug-resistant bacteria. The smart prompt provides doctors with real-time advice, aiding in the selection of antibiotics more likely to combat resistant germs. In past trials, these prompts improved antibiotic choices in hospitals. This suggests that using the smart prompt can enhance the effectiveness and safety of treatments for patients with UTIs. Meanwhile, participants in the routine care arm will continue with standard antibiotic stewardship strategies. ^{1 3 4 5 6}

Who Is on the Research Team?

Richard Platt, MD, MS

Principal Investigator

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH

Principal Investigator

UC Irvine Div Infectious Diseases

Shruti Gohil, MD, MPH

Principal Investigator

UC Irvine Div Infectious Diseases

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of routine empiric antibiotic stewardship practices and real-time precision medicine computerized physician order entry smart prompts

15 months

Empiric Treatment

Patients receive empiric antibiotic treatment during the first 3 days of hospitalization

3 days

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INSPIRE CPOE Smart Prompt

Trial Overview 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.

How Is the Trial Designed?

Group I: INSPIRE CPOE Smart Prompt Active Control 1 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 Care Active Control 1 Intervention

Continued routine antibiotic stewardship strategies.

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Hospital Corporation of America

Industry Sponsor

Trials

8

Recruited

3,433,000+

Hospital Corporation of America Healthcare (HCA)

Collaborator

Trials

2

Recruited

100,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11185978/

Stewardship Prompts to Improve Antibiotic Selection for ... INSPIRE Urinary Tract Infection Trial - Sensitivity Analyses of Effectiveness Outcomes Measured as Antibiotic Doses Per Patient

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/96/NCT03697096/SAP_001.pdf

INSPIRE-ASP Urinary Tract Infection Trial Statistical ... Trial outcomes evaluating intervention effectiveness are found in Table 1 below and trial safety outcomes are found in Table 2 below. Table 1: ...

3. ucihealth.org ucihealth.org/-/media/files/pdf/inspire-clinical-trial/gohil--stewardship-prompts-to-improve-antibiotic-selection-for-uti--the-inspire-randomized-clinical.pdf

Stewardship Prompts to Improve Antibiotic Selection for ... This study evaluated the effect of the INSPIRE antibiotic stewardship bundle, consisting of education, feedback, and computerized provider order entry. (CPOE) ...

4. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/grand-rounds-may-31-2024-inspire-abdominal-skin-soft-tissue-infection-trials-intelligent-stewardship-prompts-to-improve-real-time-empiric-antibiotic-selection-for-patients-shruti-k-gohil-md-m/

INSPIRE Abdominal & Skin/Soft Tissue Infection Trials ... The INSPIRE trials demonstrated the effectiveness of real-time, individualized smart prompts. In both the abdominal infection trial and the ...

5. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/computerized-stewardship-prompt-linked-improved-antibiotic-prescribing-2

Computerized stewardship prompt linked to improved ... The two INSPIRE (Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection) trials involved adult patients hospitalized ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03697096

Study Details | NCT03697096 | The INSPIRE-ASP UTI Trial 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 ...