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PneumoniaNCT03697070

The INSPIRE-ASP PNA Trial

A study testing INSPIRE CPOE Smart Prompt and Routine Care in people with Pneumonia, run by Harvard Pilgrim Health Care at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia
What is being tested?
INSPIRE CPOE Smart Prompt and Routine Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44,780 participants
Where
59 sitesUnited States
Study dates
1 Oct 2018to 16 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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. Prisoners were excluded from prompts and analysis.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • South Austin Hospital

    Austin, Texas, 78704

  • St. David's Medical Center

    Austin, Texas, 78705

  • LewisGale Hospital - Montgomery

    Blacksburg, Virginia, 24060

  • Brandon Regional

    Brandon, Florida, 33511

  • Valley Regional Medical Center

    Brownsville, Texas, 78526

  • West Valley Medical Center

    Caldwell, Idaho, 83605

  • Cartersville Medical Center

    Cartersville, Georgia, 30120

  • Conroe Regional Medical Center

    Conroe, Texas, 77304

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

    Corpus Christi, Texas, 78411

  • Medical City Denton

    Denton, Texas, 76210

  • Swedish Medical Center

    Denver, Colorado, 80113

  • Sky Ridge Medical Center

    Denver, Colorado, 80124

  • Rose Medical Center

    Denver, Colorado, 80220

  • TriStar Horizon Medical Center

    Dickson, Tennessee, 37055

  • Fairview Park

    Dublin, Georgia, 31021

  • Fort Walton Medical Center

    Fort Walton Beach, Florida, 32547

  • Medical City Fort Worth

    Fort Worth, Texas, 76104

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • John Randolph Medical Center

    Hopewell, Virginia, 23860

  • West Houston Medical Center

    Houston, Texas, 77082

  • Centerpoint Medical Center

    Independence, Missouri, 64057

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kingwood Medical Center

    Kingwood, Texas, 77339

  • Osceola Regional Medical Center

    Kissimmee, Florida, 34741

  • Poinciana Medical Center

    Kissimmee, Florida, 34758

  • Lake City Medical Center

    Lake City, Florida, 32055

  • Largo Medical Center

    Largo, Florida, 33770

  • Southern Hills Hospital - Vegas

    Las Vegas, Nevada, 89148

  • Northwest Medical Center

    Margate, Florida, 33063

  • Rio Grande Regional Hospital

    McAllen, Texas, 78503

  • Kendall Regional Medical Center

    Miami, Florida, 33175

  • Stonecrest Medical Center

    Nashville, Tennessee, 37167

  • Tulane University Hospital & Clinic

    New Orleans, Louisiana, 70112

  • Twin Cities Hospital

    Niceville, Florida, 32578

  • North Hills Hospital

    North Richland Hills, Texas, 76180

  • Putnam Community Medical Center

    Palatka, Florida, 80218

  • Gulf Coast Medical Center

    Panama City, Florida, 32405

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • Medical City Plano

    Plano, Texas, 75075

  • Westside Regional Medical Center

    Plantation, Florida, 33324

  • Fawcett Memorial Hospital

    Port Charlotte, Florida, 33952

  • St. Lucie Medical Center

    Port Saint Lucie, Florida, 34952

  • LewisGale Hospital - Pulaski

    Pulaski, Virginia, 24301

  • Reston Hospital

    Reston, Virginia, 20190

  • CJW Medical Center (Chippenham & Johnston Willis Campuses)

    Richmond, Virginia, 23225

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

    Richmond, Virginia, 23229

  • Riverside Community Hospital

    Riverside, California, 92501

  • Redmond Regional Medical Center

    Rome, Georgia, 30165

  • Round Rock Hospital

    Round Rock, Texas, 78681

  • Metropolitan Methodist Hospital

    San Antonio, Texas, 78212

  • Regional Medical Center of San Jose

    San Jose, California, 95116

  • Central Florida Regional Hospital

    Sanford, Florida, 32771

  • Doctor's Hospital Sarasota

    Sarasota, Florida, 34233

  • Capital Regional Medical Center

    Tallahassee, Florida, 32308

  • Terre Haute Regional Hospital

    Terre Haute, Indiana, 47802

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • Medical Center of Trinity

    Trinity, Florida, 34655

  • Clearlake Regional Medical Center

    Webster, Texas, 77598

Other trials in United States

About this study

Official title: INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Pneumonia

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
Being tested
INSPIRE CPOE Smart Prompt, Routine Care
Keywords
PNA, CPOE, Empiric Therapy
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSPIRE CPOE Smart PromptOther

    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 CareOther

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

Study groups in NCT03697070
Study groupRoleWhat they receive
Routine CareActive comparatorContinued routine antibiotic stewardship strategies.
Receives: Other: Routine Care
INSPIRE CPOE Smart PromptActive comparatorUse 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.
Receives: Other: INSPIRE CPOE Smart Prompt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Vancomycin Days of Antibacterial Therapy Per Empiric Day

    The number of days that Vancomycin is received by the patient 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.

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

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

    The number of different antipseudomonals received by the patient each empiric day of therapy, 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion16 May 2024
  4. Study completion16 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking
None (open label)
Enrolment
44,780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697070
Sponsor's protocol ID
PH000619B_PNA
Status last verified
Dec 2024
First submitted
3 Oct 2018
Last updated
29 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38639729

  • Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.

    PubMed 42268612

Questions about this trial

What is this clinical trial studying?

A study testing INSPIRE CPOE Smart Prompt and Routine Care in people with Pneumonia, run by Harvard Pilgrim Health Care at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day (time frame: First 3 days of hospitalization for each patient during 15-month intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697070, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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The INSPIRE-ASP PNA Trial (NCT03697070) | AzTrials