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NCT03697070 Clinical Trial

The INSPIRE-ASP PNA Trial

Pneumonia Clinical Trial

Official title:
INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Pneumonia: The INSPIRE-ASP PNA Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03697070
Other study ID # PH000619B_PNA
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date June 30, 2025

Study information
Verified date September 2023
Source Harvard Pilgrim Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The INSPIRE-ASP PNA 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 PNA is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 59
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Facility Inclusion Criteria: - HCA hospitals admitting adults with PNA - 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 PNA.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• INSPIRE CPOE Smart Prompt
Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having PNA due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards.
• Routine Care
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.

Locations
Country Name City State
United States The Medical Center of Aurora Aurora Colorado
United States South Austin Hospital Austin Texas
United States St. David's Medical Center Austin Texas
United States LewisGale Hospital - Montgomery Blacksburg Virginia
United States Brandon Regional Brandon Florida
United States Valley Regional Medical Center Brownsville Texas
United States West Valley Medical Center Caldwell Idaho
United States Cartersville Medical Center Cartersville Georgia
United States Conroe Regional Medical Center Conroe Texas
United States Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses) Corpus Christi Texas
United States Medical City Denton Denton Texas
United States Rose Medical Center Denver Colorado
United States Sky Ridge Medical Center Denver Colorado
United States Swedish Medical Center Denver Colorado
United States TriStar Horizon Medical Center Dickson Tennessee
United States Fairview Park Dublin Georgia
United States Fort Walton Medical Center Fort Walton Beach Florida
United States Medical City Fort Worth Fort Worth Texas
United States North Florida Regional Medical Center Gainesville Florida
United States John Randolph Medical Center Hopewell Virginia
United States West Houston Medical Center Houston Texas
United States Centerpoint Medical Center Independence Missouri
United States Research Medical Center Kansas City Missouri
United States Kingwood Medical Center Kingwood Texas
United States Osceola Regional Medical Center Kissimmee Florida
United States Poinciana Medical Center Kissimmee Florida
United States Lake City Medical Center Lake City Florida
United States Largo Medical Center Largo Florida
United States Southern Hills Hospital - Vegas Las Vegas Nevada
United States Northwest Medical Center Margate Florida
United States Rio Grande Regional Hospital McAllen Texas
United States Kendall Regional Medical Center Miami Florida
United States Stonecrest Medical Center Nashville Tennessee
United States Tulane University Hospital & Clinic New Orleans Louisiana
United States Twin Cities Hospital Niceville Florida
United States North Hills Hospital North Richland Hills Texas
United States Putnam Community Medical Center Palatka Florida
United States Gulf Coast Medical Center Panama City Florida
United States Bayshore Medical Center Pasadena Texas
United States Medical City Plano Plano Texas
United States Westside Regional Medical Center Plantation Florida
United States Fawcett Memorial Hospital Port Charlotte Florida
United States St. Lucie Medical Center Port Saint Lucie Florida
United States LewisGale Hospital - Pulaski Pulaski Virginia
United States Reston Hospital Reston Virginia
United States CJW Medical Center (Chippenham & Johnston Willis Campuses) Richmond Virginia
United States Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses) Richmond Virginia
United States Riverside Community Hospital Riverside California
United States Redmond Regional Medical Center Rome Georgia
United States Round Rock Hospital Round Rock Texas
United States Metropolitan Methodist Hospital San Antonio Texas
United States Regional Medical Center of San Jose San Jose California
United States Central Florida Regional Hospital Sanford Florida
United States Doctor's Hospital Sarasota Sarasota Florida
United States Capital Regional Medical Center Tallahassee Florida
United States Terre Haute Regional Hospital Terre Haute Indiana
United States Los Robles Regional Medical Center Thousand Oaks California
United States Medical Center of Trinity Trinity Florida
United States Clearlake Regional Medical Center Webster Texas

Sponsors (6)
Lead Sponsor Collaborator
Harvard Pilgrim Health Care Brigham and Women's Hospital, Centers for Disease Control and Prevention, Hospital Corporation of America Healthcare (HCA), University of California, Irvine, University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Antibacterial Escalations [Safety Outcome 1] Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay.
Note: this outcome is intended for the primary manuscript.		 15 month intervention
Other ICU Transfers [Safety Outcome 2] Days from start of hospitalization until ICU transfer within hospital stay
Note: this outcome is intended for the primary manuscript.		 15 month intervention
Other Length-of-stay [Safety Outcome 3] Days from hospital admission to discharge
Note: this outcome is intended for the primary manuscript.		 15 month intervention
Other Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period The summed number of different ES antibacterials received each day, measured repeatedly on or after 4 calendar days of admission and divided by the number of days from hospital day 4 through discharge.
Note: this outcome is intended for a secondary manuscript.		 15 month intervention
Other Empiric and Total Antibacterial Costs Empiric and total antibacterial costs during hospitalization.
Note: this outcome is intended for a secondary manuscript.		 15 month intervention
Other Incidence of Hospital-Onset C. difficile Hospital-onset C. difficile positive tests (specimen obtained) after 3 calendar days of admission during hospitalization.
Note: this outcome is intended for a secondary manuscript.		 15 month intervention
Other Incidence of Hospital-Onset MDRO-Positive Cultures Newly-detected hospital-onset MDRO-positive cultures (on or after 3 calendar days of admission). Includes total MDRO and specific MDRO subsets.
Note: this outcome is intended for a secondary manuscript.		 15 month intervention
Other Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days The summed number of different fluoroquinolone antibacterials received each day, measured repeatedly over (1) the first three days (empiric) of an admission and divided by the number of days of the admission and (2) all days of an admission divided by the total number of admission days.
Note: this outcome is intended for a secondary manuscript.		 15 month intervention
Primary Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day The summed number of different extended-spectrum antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission. 15 month intervention
Secondary Vancomycin Days of Antibacterial Therapy per Empiric Day The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission). 15 month intervention
Secondary Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day The summed number of different antipseudomonal antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission. 15 month intervention
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