Trial Outcomes & Findings for INSPIRE Trial for Abdominal Infections (NCT NCT05423743)

Last Updated: 2025-08-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

198480 participants

Primary outcome timeframe

First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

Results posted on

2025-08-15

Participant Flow

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).

198,480 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.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure	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.	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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Baseline (12 Months) STARTED	46725 46	46751 46
Baseline (12 Months) COMPLETED	46725 46	46751 46
Baseline (12 Months) NOT COMPLETED	0 0	0 0
Intervention (12 Months) STARTED	54384 46	50620 44
Intervention (12 Months) COMPLETED	54384 46	50620 44
Intervention (12 Months) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day Baseline (12 months)	68616 Extended-Spectrum Days-of-Therapy	68679 Extended-Spectrum Days-of-Therapy
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day Intervention (12 months)	76605 Extended-Spectrum Days-of-Therapy	50001 Extended-Spectrum Days-of-Therapy

SECONDARY outcome

Timeframe: 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

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. Vancomycin days-of-therapy per empiric day is defined as the the number of days that vancomycin is received by a patient, averaged over the empiric period, and summed across all participants. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Vancomycin Days of Antibacterial Therapy Per Empiric Day Baseline (12 months)	13019 Vancomycin Days-of-Therapy	13198 Vancomycin Days-of-Therapy
Vancomycin Days of Antibacterial Therapy Per Empiric Day Intervention (12 months)	12780 Vancomycin Days-of-Therapy	13019 Vancomycin Days-of-Therapy

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day Baseline (12 months)	49377 Antipseudomonal Days-of-Therapy	49249 Antipseudomonal Days-of-Therapy
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day Intervention (12 months)	56465 Antipseudomonal Days-of-Therapy	34362 Antipseudomonal Days-of-Therapy

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Intensive Care Unit (ICU) Transfer [Safety Outcome 1] Baseline (12 months)	5.4 Days to event Standard Deviation 3.4	5.4 Days to event Standard Deviation 3.4
Intensive Care Unit (ICU) Transfer [Safety Outcome 1] Intervention (12 months)	5.5 Days to event Standard Deviation 3.5	5.5 Days to event Standard Deviation 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.
Length-of-stay [Safety Outcome 2] Baseline (12 months)	5.5 Days to event Standard Deviation 2.8	5.6 Days to event Standard Deviation 2.9
Length-of-stay [Safety Outcome 2] Intervention (12 months)	5.7 Days to event Standard Deviation 2.9	5.8 Days to event Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shruti Gohil, MD, MPH

Division of Infectious Diseases, University of California Irvine School of Medicine

Phone: (714) 456-7890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1: Routine Stewardship n=101109 Participants Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 2: INSPIRE CPOE Bundle n=97371 Participants 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 abdominal infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 an abdominal 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.	Total n=198480 Participants Total of all reporting groups
Age, Continuous Baseline (12 months)	61 years STANDARD_DEVIATION 19 • n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	59 years STANDARD_DEVIATION 19 • n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	60 years STANDARD_DEVIATION 19 • n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Age, Continuous Intervention (12 months)	61 years STANDARD_DEVIATION 19 • n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	59 years STANDARD_DEVIATION 19 • n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	60 years STANDARD_DEVIATION 19 • n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Baseline (12 months) · Female	28375 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	28249 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	56624 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Baseline (12 months) · Male	18185 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	18349 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	36534 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Baseline (12 months) · Unknown	165 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	153 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	318 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Intervention (12 months) · Female	32114 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	29985 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	62099 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Intervention (12 months) · Male	22268 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	20635 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	42903 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex/Gender, Customized Intervention (12 months) · Unknown	2 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	0 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	2 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Baseline (12 months) · Black	4591 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	5754 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	10345 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Baseline (12 months) · White	35197 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	33004 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	68201 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Baseline (12 months) · Other	2915 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	1702 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	4617 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Baseline (12 months) · Unknown	4022 Participants n=46725 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	6291 Participants n=46751 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	10313 Participants n=93476 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Intervention (12 months) · Black	5730 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	6033 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	11763 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Intervention (12 months) · White	39497 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	35429 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	74926 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Intervention (12 months) · Other	1981 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	1066 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	3047 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Intervention (12 months) · Unknown	7176 Participants n=54384 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	8092 Participants n=50620 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	15268 Participants n=105004 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.