Clinical trial NCT05423756: INSPIRE Trial for Skin and Soft Tissue Infections
Official title: The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin and Soft Tissue (SST) Infection
Keywords: SST
CPOE
Empiric Therapy
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Hospital Corporation of America
name: University of California, Irvine
name: University of Massachusetts, Amherst
name: Brigham and Women's Hospital
name: Rush University
First posted: 2022-06-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: OTHER

Brief summary: The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.


Eligibility criteria: Facility Inclusion Criteria:

1. HCA Healthcare hospitals admitting adults for skin and soft tissue infection
2. Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age \>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.

Primary outcomes:
measure: Empiric Extended-Spectrum Antibacterial Days of Therapy (Empiric ES-DOT)
timeFrame: 12 month intervention
Secondary outcomes:
measure: Antipseudomonal Antibiotic Days of Therapy per Empiric Day
timeFrame: 12 months
Other outcomes:
measure: Intensive Care Unit (ICU) Transfer [Safety Outcome]
timeFrame: 12 months
measure: Length-of-stay [Safety Outcome]
timeFrame: 12 months
measure: Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period
timeFrame: 12 months
measure: Empiric and Total Antibiotic Costs
timeFrame: 12 months
measure: Incidence of Hospital-Onset C. difficile
timeFrame: 12 months
measure: Incidence of Hospital-Onset MDRO-Positive Cultures
timeFrame: 12 months
Locations:
city: Riverside
country: United States
facility: Riverside Community hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Center of San Jose
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital & Medical Center
state: California
city: West Hills
country: United States
facility: West Hills Hospital & Medical Center
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Lone Tree
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Thornton
country: United States
facility: North Suburban Medical Center
state: Colorado
city: Bradenton
country: United States
facility: Blake Medical Center
state: Florida
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Brooksville
country: United States
facility: Oak Hill Hospital
state: Florida
city: Englewood
country: United States
facility: Englewood Community Hospital
state: Florida
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Fort Walton Beach
country: United States
facility: Fort Walton Beach Medical Center
state: Florida
city: Hudson
country: United States
facility: Regional Medical Center Bayonet Point
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Lake City
country: United States
facility: Lake City Medical Center
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Margate
country: United States
facility: Northwest Medical Center
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: St. Lucie Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Palms of Pasadena
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: St. Petersburg General Hospital
state: Florida
city: Sarasota
country: United States
facility: Doctors Hospital of Sarasota
state: Florida
city: Sun City Center
country: United States
facility: South Bay Hospital
state: Florida
city: Tallahassee
country: United States
facility: Capital Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: HCA Florida South Tampa Hospital
state: Florida
city: Tampa
country: United States
facility: HCA Florida West Tampa Hospital
state: Florida
city: Trinity
country: United States
facility: Medical Center of Trinity
state: Florida
city: West Palm Beach
country: United States
facility: JFK Medical Center - North Campus
state: Florida
city: Dublin
country: United States
facility: Fairview Park Hospital
state: Georgia
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional Medical Center
state: Idaho
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Woodlawn Hospital & ER
state: Kansas
city: Bowling Green
country: United States
facility: TriStar Greenview Regional Hospital
state: Kentucky
city: Covington
country: United States
facility: Lakeview Regional Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lee's Summit
country: United States
facility: Lee's Summit Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Southern Hills Hospital & Medical Center
state: Nevada
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge East Hospital
state: Tennessee
city: Dickson
country: United States
facility: TriStar Horizon Medical Center
state: Tennessee
city: Hendersonville
country: United States
facility: TriStar Hendersonville Medical Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: TriStar Southern Hills Medical Center
state: Tennessee
city: Smyrna
country: United States
facility: TriStar StoneCrest Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Medical City Arlington
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Austin
country: United States
facility: St. David's North Austin Medical Center
state: Texas
city: Brownsville
country: United States
facility: Valley Regional Medical Center
state: Texas
city: Conroe
country: United States
facility: HCA Houston Healthcare Conroe
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center - Doctors Regional
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center - Bay Area
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center - Heart Hospital
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Denton
country: United States
facility: Medical City Denton
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
city: El Paso
country: United States
facility: Del Sol Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fortworth
state: Texas
city: Fort Worth
country: United States
facility: Medical City Alliance
state: Texas
city: Frisco
country: United States
facility: Medical City Frisco
state: Texas
city: Houston
country: United States
facility: HCA Houston Healthcare West
state: Texas
city: Irving
country: United States
facility: Medical City Las Colinas
state: Texas
city: Kingwood
country: United States
facility: HCA Houston Healthcare Kingwood
state: Texas
city: Lewisville
country: United States
facility: Medical City Lewisville
state: Texas
city: Live Oak
country: United States
facility: Methodist Hospital | Metropolitan
state: Texas
city: Live Oak
country: United States
facility: Methodist Hospital | Northeast
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital Main Campus
state: Texas
city: McKinney
country: United States
facility: Medical City McKinney
state: Texas
city: North Richland Hills
country: United States
facility: Medical City North Hills
state: Texas
city: Pasadena
country: United States
facility: HCA Houston Healthcare Southeast
state: Texas
city: Pearland
country: United States
facility: HCA Houston Healthcare Pearland
state: Texas
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: Round Rock
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital | Texsan
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital | Specialty and Trasnplant
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Texas City
country: United States
facility: HCA Houston Healthcare Mainland
state: Texas
city: Weatherford
country: United States
facility: Medical City Weatherford
state: Texas
city: Webster
country: United States
facility: HCA Houston Healthcare Clear Lake
state: Texas
city: Ogden
country: United States
facility: Ogden Regional Medical Center
state: Utah
city: Blacksburg
country: United States
facility: LewisGale Hospital Montgomery
state: Virginia
city: Hopewell
country: United States
facility: John Randolph Medical Center
state: Virginia
city: Pulaski
country: United States
facility: LewisGale Hospital Pulaski
state: Virginia
city: Reston
country: United States
facility: Reston Hospital Center
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctor's Hospital
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Chippenham & Johnston Willis Campuses)
state: Virginia
city: Salem
country: United States
facility: LewisGale Medical Center
state: Virginia
Study officials:
affiliation: UC Irvine Division of Infectious Diseases
name: Shruti Gohil, MD, MPH
role: STUDY_DIRECTOR
affiliation: UC Irvine Division of Infectious Diseases
name: Susan Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Pilgrim Health Care Institute/Harvard Medical School
name: Richard Platt, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: