The INSPIRE-ASP PNA Trial

NCT03697070 | Completed Results

• 1 other identifier: PH000619B_PNA
• Study Type: interventional
• Target: 44,780
• Locations: 1 country
• Sites: 59

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.

Conditions

Pneumonia

Keywords

PNA; CPOE; Empiric Therapy

Outcome Measures

Primary Outcomes (1)

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

  The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.

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

Secondary Outcomes (2)

• Vancomycin Days of Antibacterial Therapy Per Empiric Day

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

• Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day

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

Other Outcomes (8)

• Antibacterial Escalations [Safety Outcome 1]

  Duration of hospitalization for each patient during 15-month intervention period

• ICU Transfers [Safety Outcome 2]

  Duration of hospitalization for each patient during 15-month intervention period

• Length-of-stay [Safety Outcome 3]

  Duration of hospitalization for each patient during 15-month intervention period

Study Arms (2)

Routine Care

ACTIVE COMPARATOR

Continued routine antibiotic stewardship strategies.

Other: Routine Care

INSPIRE CPOE Smart Prompt

ACTIVE COMPARATOR

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

Interventions

INSPIRE CPOE Smart Prompt OTHER

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.

INSPIRE CPOE Smart Prompt

Routine Care OTHER

Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCA hospitals admitting adults with PNA
• Facility use of MEDITECH as their electronic health record system

You may not qualify if:

• 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. Prisoners were excluded from prompts and analysis.

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Hospital Corporation of America: collaborator
• University of California, Irvine: collaborator
• University of Massachusetts, Amherst: collaborator
• Brigham and Women's Hospital: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (59)

Riverside Community Hospital

Riverside, California, 92501, United States

Location

Regional Medical Center of San Jose

San Jose, California, 95116, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Swedish Medical Center

Denver, Colorado, 80113, United States

Location

Sky Ridge Medical Center

Denver, Colorado, 80124, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Brandon Regional

Brandon, Florida, 33511, United States

Location

Fort Walton Medical Center

Fort Walton Beach, Florida, 32547, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

Poinciana Medical Center

Kissimmee, Florida, 34758, United States

Location

Lake City Medical Center

Lake City, Florida, 32055, United States

Location

Largo Medical Center

Largo, Florida, 33770, United States

Location

Northwest Medical Center

Margate, Florida, 33063, United States

Location

Kendall Regional Medical Center

Miami, Florida, 33175, United States

Location

Twin Cities Hospital

Niceville, Florida, 32578, United States

Location

Putnam Community Medical Center

Palatka, Florida, 80218, United States

Location

Gulf Coast Medical Center

Panama City, Florida, 32405, United States

Location

Westside Regional Medical Center

Plantation, Florida, 33324, United States

Location

Fawcett Memorial Hospital

Port Charlotte, Florida, 33952, United States

Location

St. Lucie Medical Center

Port Saint Lucie, Florida, 34952, United States

Location

Central Florida Regional Hospital

Sanford, Florida, 32771, United States

Location

Doctor's Hospital Sarasota

Sarasota, Florida, 34233, United States

Location

Capital Regional Medical Center

Tallahassee, Florida, 32308, United States

Location

Medical Center of Trinity

Trinity, Florida, 34655, United States

Location

Cartersville Medical Center

Cartersville, Georgia, 30120, United States

Location

Fairview Park

Dublin, Georgia, 31021, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

West Valley Medical Center

Caldwell, Idaho, 83605, United States

Location

Terre Haute Regional Hospital

Terre Haute, Indiana, 47802, United States

Location

Tulane University Hospital & Clinic

New Orleans, Louisiana, 70112, United States

Location

Centerpoint Medical Center

Independence, Missouri, 64057, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Southern Hills Hospital - Vegas

Las Vegas, Nevada, 89148, United States

Location

TriStar Horizon Medical Center

Dickson, Tennessee, 37055, United States

Location

Stonecrest Medical Center

Nashville, Tennessee, 37167, United States

Location

South Austin Hospital

Austin, Texas, 78704, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

Valley Regional Medical Center

Brownsville, Texas, 78526, United States

Location

Conroe Regional Medical Center

Conroe, Texas, 77304, United States

Location

Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses)

Corpus Christi, Texas, 78411, United States

Location

Medical City Denton

Denton, Texas, 76210, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

West Houston Medical Center

Houston, Texas, 77082, United States

Location

Kingwood Medical Center

Kingwood, Texas, 77339, United States

Location

Rio Grande Regional Hospital

McAllen, Texas, 78503, United States

Location

North Hills Hospital

North Richland Hills, Texas, 76180, United States

Location

Bayshore Medical Center

Pasadena, Texas, 77504, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

Round Rock Hospital

Round Rock, Texas, 78681, United States

Location

Metropolitan Methodist Hospital

San Antonio, Texas, 78212, United States

Location

Clearlake Regional Medical Center

Webster, Texas, 77598, United States

Location

LewisGale Hospital - Montgomery

Blacksburg, Virginia, 24060, United States

Location

John Randolph Medical Center

Hopewell, Virginia, 23860, United States

Location

LewisGale Hospital - Pulaski

Pulaski, Virginia, 24301, United States

Location

Reston Hospital

Reston, Virginia, 20190, United States

Location

CJW Medical Center (Chippenham & Johnston Willis Campuses)

Richmond, Virginia, 23225, United States

Location

Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses)

Richmond, Virginia, 23229, United States

Location

Related Publications (1)

• Gohil SK, Septimus E, Kleinman K, Varma N, Avery TR, Heim L, Rahm R, Cooper WS, Cooper M, McLean LE, Nickolay NG, Weinstein RA, Burgess LH, Coady MH, Rosen E, Sljivo S, Sands KE, Moody J, Vigeant J, Rashid S, Gilbert RF, Smith KN, Carver B, Poland RE, Hickok J, Sturdevant SG, Calderwood MS, Weiland A, Kubiak DW, Reddy S, Neuhauser MM, Srinivasan A, Jernigan JA, Hayden MK, Gowda A, Eibensteiner K, Wolf R, Perlin JB, Platt R, Huang SS. Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial. JAMA. 2024 Jun 18;331(23):2007-2017. doi: 10.1001/jama.2024.6248.

  PMID: 38639729 RESULT

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Dr. Shruti Gohil, MD, MPH
• Organization: Division of Infectious Diseases, University of California Irvine School of Medicine

skgohil@hs.uci.edu

(714) 456-7890

Study Officials

• Shruti Gohil, MD, MPH

  UC Irvine Div Infectious Diseases

  STUDY DIRECTOR

• Susan Huang, MD, MPH

  UC Irvine Div Infectious Diseases

  PRINCIPAL INVESTIGATOR

• Richard Platt, MD, MS

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Population Medicine

Model Details: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: October 1, 2018
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (59)