The INSPIRE-ASP PNA Trial
Study Details
Study Description
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 |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
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.
|
Outcome Measures
Primary Outcome Measures
- Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day [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
- Vancomycin Days of Antibacterial Therapy per Empiric Day [15 month intervention]
The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission).
- Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day [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
- Antibacterial Escalations [Safety Outcome 1] [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.
- ICU Transfers [Safety Outcome 2] [15 month intervention]
Days from start of hospitalization until ICU transfer within hospital stay Note: this outcome is intended for the primary manuscript.
- Length-of-stay [Safety Outcome 3] [15 month intervention]
Days from hospital admission to discharge Note: this outcome is intended for the primary manuscript.
- Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibacterial Treatment after Empiric Period [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.
- Empiric and Total Antibacterial Costs [15 month intervention]
Empiric and total antibacterial costs during hospitalization. Note: this outcome is intended for a secondary manuscript.
- Incidence of Hospital-Onset C. difficile [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.
- Incidence of Hospital-Onset MDRO-Positive Cultures [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.
- Fluoroquinolone (FQ) Days of Therapy per Empiric and Total At-risk Days [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.
Eligibility Criteria
Criteria
Facility Inclusion Criteria:
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HCA hospitals admitting adults with PNA
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Riverside Community Hospital | Riverside | California | United States | 92501 |
2 | Regional Medical Center of San Jose | San Jose | California | United States | 95116 |
3 | Los Robles Regional Medical Center | Thousand Oaks | California | United States | 91360 |
4 | The Medical Center of Aurora | Aurora | Colorado | United States | 80012 |
5 | Swedish Medical Center | Denver | Colorado | United States | 80113 |
6 | Sky Ridge Medical Center | Denver | Colorado | United States | 80124 |
7 | Rose Medical Center | Denver | Colorado | United States | 80220 |
8 | Brandon Regional | Brandon | Florida | United States | 33511 |
9 | Fort Walton Medical Center | Fort Walton Beach | Florida | United States | 32547 |
10 | North Florida Regional Medical Center | Gainesville | Florida | United States | 32605 |
11 | Osceola Regional Medical Center | Kissimmee | Florida | United States | 34741 |
12 | Poinciana Medical Center | Kissimmee | Florida | United States | 34758 |
13 | Lake City Medical Center | Lake City | Florida | United States | 32055 |
14 | Largo Medical Center | Largo | Florida | United States | 33770 |
15 | Northwest Medical Center | Margate | Florida | United States | 33063 |
16 | Kendall Regional Medical Center | Miami | Florida | United States | 33175 |
17 | Twin Cities Hospital | Niceville | Florida | United States | 32578 |
18 | Putnam Community Medical Center | Palatka | Florida | United States | 80218 |
19 | Gulf Coast Medical Center | Panama City | Florida | United States | 32405 |
20 | Westside Regional Medical Center | Plantation | Florida | United States | 33324 |
21 | Fawcett Memorial Hospital | Port Charlotte | Florida | United States | 33952 |
22 | St. Lucie Medical Center | Port Saint Lucie | Florida | United States | 34952 |
23 | Central Florida Regional Hospital | Sanford | Florida | United States | 32771 |
24 | Doctor's Hospital Sarasota | Sarasota | Florida | United States | 34233 |
25 | Capital Regional Medical Center | Tallahassee | Florida | United States | 32308 |
26 | Medical Center of Trinity | Trinity | Florida | United States | 34655 |
27 | Cartersville Medical Center | Cartersville | Georgia | United States | 30120 |
28 | Fairview Park | Dublin | Georgia | United States | 31021 |
29 | Redmond Regional Medical Center | Rome | Georgia | United States | 30165 |
30 | West Valley Medical Center | Caldwell | Idaho | United States | 83605 |
31 | Terre Haute Regional Hospital | Terre Haute | Indiana | United States | 47802 |
32 | Tulane University Hospital & Clinic | New Orleans | Louisiana | United States | 70112 |
33 | Centerpoint Medical Center | Independence | Missouri | United States | 64057 |
34 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
35 | Southern Hills Hospital - Vegas | Las Vegas | Nevada | United States | 89148 |
36 | TriStar Horizon Medical Center | Dickson | Tennessee | United States | 37055 |
37 | Stonecrest Medical Center | Nashville | Tennessee | United States | 37167 |
38 | South Austin Hospital | Austin | Texas | United States | 78704 |
39 | St. David's Medical Center | Austin | Texas | United States | 78705 |
40 | Valley Regional Medical Center | Brownsville | Texas | United States | 78526 |
41 | Conroe Regional Medical Center | Conroe | Texas | United States | 77304 |
42 | Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses) | Corpus Christi | Texas | United States | 78411 |
43 | Medical City Denton | Denton | Texas | United States | 76210 |
44 | Medical City Fort Worth | Fort Worth | Texas | United States | 76104 |
45 | West Houston Medical Center | Houston | Texas | United States | 77082 |
46 | Kingwood Medical Center | Kingwood | Texas | United States | 77339 |
47 | Rio Grande Regional Hospital | McAllen | Texas | United States | 78503 |
48 | North Hills Hospital | North Richland Hills | Texas | United States | 76180 |
49 | Bayshore Medical Center | Pasadena | Texas | United States | 77504 |
50 | Medical City Plano | Plano | Texas | United States | 75075 |
51 | Round Rock Hospital | Round Rock | Texas | United States | 78681 |
52 | Metropolitan Methodist Hospital | San Antonio | Texas | United States | 78212 |
53 | Clearlake Regional Medical Center | Webster | Texas | United States | 77598 |
54 | LewisGale Hospital - Montgomery | Blacksburg | Virginia | United States | 24060 |
55 | John Randolph Medical Center | Hopewell | Virginia | United States | 23860 |
56 | LewisGale Hospital - Pulaski | Pulaski | Virginia | United States | 24301 |
57 | Reston Hospital | Reston | Virginia | United States | 20190 |
58 | CJW Medical Center (Chippenham & Johnston Willis Campuses) | Richmond | Virginia | United States | 23225 |
59 | Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses) | Richmond | Virginia | United States | 23229 |
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
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PH000619B_PNA