CompletedNot Applicable

The INSPIRE-ASP UTI Trial

United States55,412 participantsStarted 2018-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Prisoners were excluded from prompts and analysis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day

Timeframe: First 3 days of hospitalization for each patient during 15-month intervention period

Trial details

NCT IDNCT03697096

SponsorHarvard Pilgrim Health Care

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-16

Results submitted2024-05-16

View on ClinicalTrials.gov More Urinary Tract Infection (UTI) trials