The INSPIRE-ASP PNA Trial

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Other: Routine Care; Other: INSPIRE CPOE Smart Prompt

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92501
      • Riverside Community Hospital
    • San Jose, California, United States, 95116
      • Regional Medical Center of San Jose
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
    • Denver, Colorado, United States, 80220
      • Rose Medical Center
    • Denver, Colorado, United States, 80113
      • Swedish Medical Center
    • Denver, Colorado, United States, 80124
      • Sky Ridge Medical Center
  • Florida
    • Brandon, Florida, United States, 33511
      • Brandon Regional
    • Fort Walton Beach, Florida, United States, 32547
      • Fort Walton Medical Center
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Kissimmee, Florida, United States, 34741
      • Osceola Regional Medical Center
    • Kissimmee, Florida, United States, 34758
      • Poinciana Medical Center
    • Lake City, Florida, United States, 32055
      • Lake City Medical Center
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Margate, Florida, United States, 33063
      • Northwest Medical Center
    • Miami, Florida, United States, 33175
      • Kendall Regional Medical Center
    • Niceville, Florida, United States, 32578
      • Twin Cities Hospital
    • Palatka, Florida, United States, 80218
      • Putnam Community Medical Center
    • Panama City, Florida, United States, 32405
      • Gulf Coast Medical Center
    • Plantation, Florida, United States, 33324
      • Westside Regional Medical Center
    • Port Charlotte, Florida, United States, 33952
      • Fawcett Memorial Hospital
    • Port Saint Lucie, Florida, United States, 34952
      • St. Lucie Medical Center
    • Sanford, Florida, United States, 32771
      • Central Florida Regional Hospital
    • Sarasota, Florida, United States, 34233
      • Doctor's Hospital Sarasota
    • Tallahassee, Florida, United States, 32308
      • Capital Regional Medical Center
    • Trinity, Florida, United States, 34655
      • Medical Center of Trinity
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Cartersville Medical Center
    • Dublin, Georgia, United States, 31021
      • Fairview Park
    • Rome, Georgia, United States, 30165
      • Redmond Regional Medical Center
  • Idaho
    • Caldwell, Idaho, United States, 83605
      • West Valley Medical Center
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Terre Haute Regional Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital & Clinic
  • Missouri
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Southern Hills Hospital - Vegas
  • Tennessee
    • Dickson, Tennessee, United States, 37055
      • TriStar Horizon Medical Center
    • Nashville, Tennessee, United States, 37167
      • Stonecrest Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's Medical Center
    • Austin, Texas, United States, 78704
      • South Austin Hospital
    • Brownsville, Texas, United States, 78526
      • Valley Regional Medical Center
    • Conroe, Texas, United States, 77304
      • Conroe Regional Medical Center
    • Corpus Christi, Texas, United States, 78411
      • Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)
    • Denton, Texas, United States, 76210
      • Medical City Denton
    • Fort Worth, Texas, United States, 76104
      • Medical City Fort Worth
    • Houston, Texas, United States, 77082
      • West Houston Medical Center
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
    • McAllen, Texas, United States, 78503
      • Rio Grande Regional Hospital
    • North Richland Hills, Texas, United States, 76180
      • North Hills Hospital
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
    • Plano, Texas, United States, 75075
      • Medical City Plano
    • Round Rock, Texas, United States, 78681
      • Round Rock Hospital
    • San Antonio, Texas, United States, 78212
      • Metropolitan Methodist Hospital
    • Webster, Texas, United States, 77598
      • Clearlake Regional Medical Center
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • LewisGale Hospital - Montgomery
    • Hopewell, Virginia, United States, 23860
      • John Randolph Medical Center
    • Pulaski, Virginia, United States, 24301
      • LewisGale Hospital - Pulaski
    • Reston, Virginia, United States, 20190
      • Reston Hospital
    • Richmond, Virginia, United States, 23225
      • CJW Medical Center (Chippenham & Johnston Willis Campuses)
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Care; Continued routine antibiotic stewardship strategies.	Other: Routine Care; Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
Active Comparator: INSPIRE CPOE Smart Prompt; Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length-of-stay [Safety Outcome 3]	Days from hospital admission to discharge Note: this outcome is intended for the primary manuscript.	15 month intervention
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
Empiric and Total Antibacterial Costs	Empiric and total antibacterial costs during hospitalization. Note: this outcome is intended for a secondary manuscript.	15 month intervention
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
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
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

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Brigham and Women's Hospital; Centers for Disease Control and Prevention; University of California, Irvine; University of Massachusetts, Amherst; Hospital Corporation of America Healthcare (HCA)
• Investigators: Principal Investigator: Richard Platt, MD, MS, Harvard Pilgrim Health Care Institute; Study Director: Shruti Gohil, MD, MPH, UC Irvine Div Infectious Diseases; Principal Investigator: Susan Huang, MD, MPH, UC Irvine Div Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: CPOE; Empiric Therapy; PNA
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: PH000619B_PNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No