Trial Outcomes & Findings for The INSPIRE-ASP PNA Trial (NCT NCT03697070)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44780 participants

Primary outcome timeframe

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

Results posted on

2025-01-29

Participant Flow

59 out of 143 HCA Healthcare hospitals were recruited for this trial. There was a 15 month intervention period from April 1, 2019 through June 30, 2020.

44,780 patients were involved in the intervention period from the 59 participating hospitals.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure	Arm 1: Routine Stewardship Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle 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.
Overall Study STARTED	21998 30	22782 29
Overall Study COMPLETED	21998 30	22782 29
Overall Study 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

Baseline characteristics by cohort
Measure	Arm 1: Routine Stewardship n=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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. 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.	Total n=44780 Participants Total of all reporting groups
Age, Continuous	67.4 years STANDARD_DEVIATION 17.3 • n=21998 Participants	68.0 years STANDARD_DEVIATION 17.0 • n=22782 Participants	68.0 years STANDARD_DEVIATION 17.0 • n=44780 Participants
Sex: Female, Male Female	11400 Participants n=21945 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	11768 Participants n=22734 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	23168 Participants n=44679 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Sex: Female, Male Male	10545 Participants n=21945 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	10966 Participants n=22734 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	21511 Participants n=44679 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Race · Black	2848 Participants n=19161 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	2908 Participants n=21417 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	5756 Participants n=40578 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Race · White	15415 Participants n=19161 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	17205 Participants n=21417 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	32620 Participants n=40578 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Race/Ethnicity, Customized Race · Other	898 Participants n=19161 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	1304 Participants n=21417 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.	2202 Participants n=40578 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.

PRIMARY outcome

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

Population: The total number of participants analyzed reported here is from the intervention period.

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day	38690 Extended-Spectrum Days-of-Therapy	27971 Extended-Spectrum Days-of-Therapy

SECONDARY outcome

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

Population: The total number of participants analyzed reported here is from the intervention period.

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
Vancomycin Days of Antibacterial Therapy Per Empiric Day	13778 Vancomycin Days-of-Therapy	10534 Vancomycin Days-of-Therapy

SECONDARY outcome

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

Population: The total number of participants analyzed reported here is from the intervention period.

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.

Outcome measures

Outcome measures
Measure	Arm 1: Routine Stewardship n=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	22683 Antipseudomonal Days-of-Therapy	15670 Antipseudomonal Days-of-Therapy

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of hospitalization for each patient during 15-month intervention period

Population: The mean number of days to event here is from the intervention period.

Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay, 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=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
Antibacterial Escalations [Safety Outcome 1]	5.3 Days to event Standard Deviation 3.8	6.1 Days to event Standard Deviation 5.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of hospitalization for each patient during 15-month intervention period

Population: The mean number of days to event here is from the intervention period.

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=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
ICU Transfers [Safety Outcome 2]	6.5 Days to event Standard Deviation 5.2	7.1 Days to event Standard Deviation 5.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of hospitalization for each patient during 15-month intervention period

Population: The mean number of days to event here is from the intervention period.

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=21998 Participants Continuation of all antibiotic stewardship activities in accordance with national standards.	Arm 2: CPOE Bundle n=22782 Participants 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.
Length-of-stay [Safety Outcome 3]	6.8 Days to event Standard Deviation 5.9	7.1 Days to event Standard Deviation 6.9

Adverse Events

Arm 1: Routine Stewardship

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: CPOE Bundle

Serious events: 0 serious events

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