Arm 1: Routine Care for Abdomen

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical City Dallas, Dallas, TX
Abdomen+2 More
Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen. Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

Eligible Conditions

  • Abdomen

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 months

12 month intervention
Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT)
12 months
Antipseudomonal Antibiotic Days of Therapy per Empiric Day
Empiric and Total Antibiotic Costs
Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period
Incidence of Hospital-Onset C. difficile
Incidence of Hospital-Onset MDRO-Positive Cultures
Intensive Care Unit (ICU) Transfer [Safety Outcome]
Length-of-stay [Safety Outcome]
Vancomycin Days of Therapy per Empiric Day

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm 1: Routine Care
1 of 2
Arm 2: INSPIRE CPOE Smart Prompt
1 of 2
Active Control

102 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1: Routine Care · No Placebo Group · N/A

Arm 1: Routine Care
Other
ActiveComparator Group · 1 Intervention: Arm 1: Routine Care · Intervention Types: Other
Arm 2: INSPIRE CPOE Smart Prompt
Other
ActiveComparator Group · 1 Intervention: Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Medical City Dallas · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
2007First Recorded Clinical Trial
0 TrialsResearching Abdomen
3 CompletedClinical Trials

Who is running the clinical trial?

HCA Healthcare, IncUNKNOWN
1 Previous Clinical Trials
102 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,453 Previous Clinical Trials
9,701,142 Total Patients Enrolled
University of Massachusetts, AmherstOTHER
65 Previous Clinical Trials
96,620 Total Patients Enrolled
University of California, IrvineOTHER
486 Previous Clinical Trials
1,874,198 Total Patients Enrolled
Rush UniversityOTHER
33 Previous Clinical Trials
21,379 Total Patients Enrolled
Harvard Pilgrim Health CareLead Sponsor
51 Previous Clinical Trials
27,363,636 Total Patients Enrolled
Richard Platt, MD, MSPrincipal InvestigatorHarvard Pilgrim Health Care Institute/Harvard Medical School
7 Previous Clinical Trials
6,074,695 Total Patients Enrolled
Susan Huang, MD, MPHPrincipal InvestigatorUC Irvine Division of Infectious Diseases
6 Previous Clinical Trials
492 Total Patients Enrolled
Shruti Gohil, MD, MPHStudy DirectorUC Irvine Division of Infectious Diseases
3 Previous Clinical Trials
220 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.