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The INSPIRE-ASP PNA Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697070
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Hospital Corporation of America Healthcare (HCA)
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Brief 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.


Condition or disease Intervention/treatment Phase
Pneumonia Other: INSPIRE CPOE Smart Prompt Other: Routine Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Pneumonia: The INSPIRE-ASP PNA Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day [ Time Frame: 15 month intervention ]
    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.


Secondary Outcome Measures :
  1. Vancomycin Days of Antibacterial Therapy per Empiric Day [ Time Frame: 15 month intervention ]
    The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission).

  2. Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day [ Time Frame: 15 month intervention ]
    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.


Other Outcome Measures:
  1. Antibacterial Escalations [Safety Outcome 1] [ Time Frame: 15 month intervention ]

    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.


  2. ICU Transfers [Safety Outcome 2] [ Time Frame: 15 month intervention ]

    Days from start of hospitalization until ICU transfer within hospital stay

    Note: this outcome is intended for the primary manuscript.


  3. Length-of-stay [Safety Outcome 3] [ Time Frame: 15 month intervention ]

    Days from hospital admission to discharge

    Note: this outcome is intended for the primary manuscript.


  4. Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period [ Time Frame: 15 month intervention ]

    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.


  5. Empiric and Total Antibacterial Costs [ Time Frame: 15 month intervention ]

    Empiric and total antibacterial costs during hospitalization.

    Note: this outcome is intended for a secondary manuscript.


  6. Incidence of Hospital-Onset C. difficile [ Time Frame: 15 month intervention ]

    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.


  7. Incidence of Hospital-Onset MDRO-Positive Cultures [ Time Frame: 15 month intervention ]

    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.


  8. Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days [ Time Frame: 15 month intervention ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697070


Contacts
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Contact: Micaela Coady, MS 617-867-4880 micaela_coady@hphc.org
Contact: Shruti K Gohil, MD, MPH 347-675-0571 skgohil@uci.edu

Locations
Show Show 59 study locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
Hospital Corporation of America Healthcare (HCA)
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Investigators
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Study Director: Shruti Gohil, MD, MPH UC Irvine Div Infectious Diseases
Principal Investigator: Susan Huang, MD, MPH UC Irvine Div Infectious Diseases
Principal Investigator: Richard Platt, MD, MS Harvard Pilgrim Health Care Institute
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Responsible Party: Richard Platt, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT03697070    
Other Study ID Numbers: PH000619B_PNA
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
PNA
CPOE
Empiric Therapy
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections