Smart Prompt System vs Routine Care for Urinary Tract Infection

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

55412 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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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+