Skin and Soft Tissue (SST) Infection
Conditions
Keywords
SST, CPOE, Empiric Therapy
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.
Interventions
OTHERArm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
OTHERArm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.
Sponsors
Harvard Pilgrim Health Care
Hospital Corporation of America
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Rush University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day | First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods | Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods | Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Antipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy. |
Countries
United States
Contacts
STUDY_DIRECTORShruti Gohil, MD, MPH
UC Irvine Division of Infectious Diseases
PRINCIPAL_INVESTIGATORSusan Huang, MD, MPH
UC Irvine Division of Infectious Diseases
PRINCIPAL_INVESTIGATORRichard Platt, MD, MS
Harvard Pilgrim Health Care Institute/Harvard Medical School
Participant flow
Recruitment details
92 out of 142 HCA Healthcare hospitals were recruited for this trial. There was a 12-month baseline period (January 1, 2019-December 31, 2019), 5-month phase-in (August 2, 2022-December 31, 2022), and 12-month intervention (January 1, 2023-December 31, 2023). Data from the phase-in period were excluded from all analyses (i.e., Baseline, Intervention, Outcome Measures, and Adverse Events).
Pre-assignment details
118,562 patients across 92 hospitals were randomized to either the routine stewardship group (Arm 1) or to the CPOE bundle (Arm 2); 2 hospitals were excluded because they divested from HCA Healthcare before the intervention period began.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Routine Stewardship Continuation of routine antibiotic stewardship strategies.
Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards. | 60,932 |
| Arm 2: INSPIRE CPOE Bundle Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.
Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards. | 57,630 |
| Total | 118,562 |
Baseline characteristics
| Characteristic | Arm 1: Routine Stewardship | Arm 2: INSPIRE CPOE Bundle | Total |
|---|---|---|---|
| Age, Continuous Baseline (12 months) | 58 years STANDARD_DEVIATION 18 | 58 years STANDARD_DEVIATION 18 | 58 years STANDARD_DEVIATION 18 |
| Age, Continuous Intervention (12 months) | 59 years STANDARD_DEVIATION 18 | 58 years STANDARD_DEVIATION 17 | 59 years STANDARD_DEVIATION 18 |
| Race/Ethnicity, Customized Baseline (12 months) Black | 3052 Participants | 3638 Participants | 6690 Participants |
| Race/Ethnicity, Customized Baseline (12 months) Other | 1246 Participants | 687 Participants | 1933 Participants |
| Race/Ethnicity, Customized Baseline (12 months) Unknown | 2144 Participants | 3187 Participants | 5331 Participants |
| Race/Ethnicity, Customized Baseline (12 months) White | 23153 Participants | 20730 Participants | 43883 Participants |
| Race/Ethnicity, Customized Intervention (12 months) Black | 3672 Participants | 3989 Participants | 7661 Participants |
| Race/Ethnicity, Customized Intervention (12 months) Other | 685 Participants | 333 Participants | 1018 Participants |
| Race/Ethnicity, Customized Intervention (12 months) Unknown | 3595 Participants | 4181 Participants | 7776 Participants |
| Race/Ethnicity, Customized Intervention (12 months) White | 23385 Participants | 20885 Participants | 44270 Participants |
| Sex/Gender, Customized Baseline (12 months) Female | 13087 Participants | 12377 Participants | 25464 Participants |
| Sex/Gender, Customized Baseline (12 months) Male | 16320 Participants | 15719 Participants | 32039 Participants |
| Sex/Gender, Customized Baseline (12 months) Unknown | 188 Participants | 146 Participants | 334 Participants |
| Sex/Gender, Customized Intervention (12 months) Female | 13356 Participants | 17015 Participants | 30371 Participants |
| Sex/Gender, Customized Intervention (12 months) Male | 17979 Participants | 12373 Participants | 30352 Participants |
| Sex/Gender, Customized Intervention (12 months) Unknown | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60,932 | 0 / 57,630 |
| other Total, other adverse events | 0 / 60,932 | 0 / 57,630 |
| serious Total, serious adverse events | 0 / 60,932 | 0 / 57,630 |
Outcome results
Primary
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.
Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Population: The total number of participants analyzed reported here is from the baseline and intervention periods
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Routine Stewardship | Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day | Baseline (12 months) | 43305 Extended-Spectrum Days-of-Therapy |
| Arm 1: Routine Stewardship | Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day | Intervention (12 months) | 43927 Extended-Spectrum Days-of-Therapy |
| Arm 2: INSPIRE CPOE Bundle | Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day | Baseline (12 months) | 40156 Extended-Spectrum Days-of-Therapy |
| Arm 2: INSPIRE CPOE Bundle | Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day | Intervention (12 months) | 30287 Extended-Spectrum Days-of-Therapy |
Secondary
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Antipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.
Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Population: The total number of participants analyzed reported here is from the baseline and intervention periods
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Routine Stewardship | Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | Baseline (12 months) | 43305 Antipseudomonal Days-of-Therapy |
| Arm 1: Routine Stewardship | Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | Intervention (12 months) | 43927 Antipseudomonal Days-of-Therapy |
| Arm 2: INSPIRE CPOE Bundle | Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | Baseline (12 months) | 38059 Antipseudomonal Days-of-Therapy |
| Arm 2: INSPIRE CPOE Bundle | Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | Intervention (12 months) | 30287 Antipseudomonal Days-of-Therapy |
Other Pre-specified
Empiric and Total Antibiotic Costs
Empiric and total antibiotic costs for skin and soft tissue infection during hospitalization. Note: this outcome is intended for a secondary manuscript.
Time frame: 12 months
Other Pre-specified
Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibiotic Treatment After Empiric Period
The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript
Time frame: 12 months
Other Pre-specified
Incidence of Hospital-Onset C. Difficile
Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript.
Time frame: 12 months
Other Pre-specified
Incidence of Hospital-Onset MDRO-Positive Cultures
Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets. Note: this outcome is intended for a secondary manuscript.
Time frame: 12 months
Other Pre-specified
Intensive Care Unit (ICU) Transfer [Safety Outcome 1]
Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.
Time frame: Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods
Population: The mean number of days to event here is from the the baseline and intervention periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Routine Stewardship | Intensive Care Unit (ICU) Transfer [Safety Outcome 1] | Baseline (12 months) | 5.9 Days to event | Standard Deviation 2.8 |
| Arm 1: Routine Stewardship | Intensive Care Unit (ICU) Transfer [Safety Outcome 1] | Intervention (12 months) | 6.3 Days to event | Standard Deviation 3.2 |
| Arm 2: INSPIRE CPOE Bundle | Intensive Care Unit (ICU) Transfer [Safety Outcome 1] | Baseline (12 months) | 6.1 Days to event | Standard Deviation 2.9 |
| Arm 2: INSPIRE CPOE Bundle | Intensive Care Unit (ICU) Transfer [Safety Outcome 1] | Intervention (12 months) | 6.3 Days to event | Standard Deviation 3.1 |
Other Pre-specified
Length-of-stay [Safety Outcome 2]
Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.
Time frame: Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods
Population: The mean number of days to event here is from the baseline and intervention periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Routine Stewardship | Length-of-stay [Safety Outcome 2] | Baseline (12 months) | 6.2 Days to event | Standard Deviation 3.7 |
| Arm 1: Routine Stewardship | Length-of-stay [Safety Outcome 2] | Intervention (12 months) | 6.5 Days to event | Standard Deviation 3.8 |
| Arm 2: INSPIRE CPOE Bundle | Length-of-stay [Safety Outcome 2] | Baseline (12 months) | 6.1 Days to event | Standard Deviation 3.6 |
| Arm 2: INSPIRE CPOE Bundle | Length-of-stay [Safety Outcome 2] | Intervention (12 months) | 6.4 Days to event | Standard Deviation 3.8 |