Trial Outcomes & Findings for Improving Antimicrobial-Prescribing in Emergency Departments (NCT NCT03349567)
NCT ID: NCT03349567
Last Updated: 2021-04-28
Results Overview
This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
COMPLETED
NA
27 participants
This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.
2021-04-28
Participant Flow
We performed a quasi-experimental study with an interrupted time-series design and a matched-pair non-equivalent control group. There were 2 intervention sites and 2 control sites; 27/31 providers were enrolled at intervention sites. We measured outcomes in the PATIENTS seen at these 4 EDs. In a difference-in-differences analysis, outcomes were compared across intervention and control sites in patients seen before the intervention period (i.e. baseline) to those during the intervention period.
Participant milestones
| Measure |
Audit-and-feedback
The experimental arm will consist of 2 Emergency Departments. We will attempt to enroll all ED providers at our 2 intervention sites, and for the analysis, site-level data will be used.
Audit-and-feedback: We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.
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Control
The control arm will consist of 2 ED sites that do not receive the intervention. For the analysis, the control sites will be analyzed at the site-level.
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|---|---|---|
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Overall Study
STARTED
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2
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2
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Overall Study
COMPLETED
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2
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2
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Antimicrobial-Prescribing in Emergency Departments
Baseline characteristics by cohort
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites During the Intervention Period
n=23164 Participants
These measures reflect patients seen at audit-and-feedback sites during the intervention period.
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Patients Seen in the ED at Control Sites During the Intervention Period
n=28835 Participants
These baseline measures reflect patients seen at control sites during the intervention period.
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Patients Seen in the ED at Audit-and-feedback Sites During the Baseline Period
n=28016 Participants
These measures reflect patients seen at audit-and-feedback sites before the intervention period, i.e. during the baseline period.
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Patients Seen in the ED at Control Sites During the Baseline Period
n=33077 Participants
These measures reflect patients seen at control sites before the intervention period, i.e. during the baseline period.
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Total
n=113092 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
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Age, Continuous
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60 years
n=5 Participants
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60 years
n=7 Participants
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60 years
n=5 Participants
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60 years
n=4 Participants
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60 years
n=21 Participants
|
|
Sex: Female, Male
Female
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2532 Participants
n=5 Participants
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2627 Participants
n=7 Participants
|
3014 Participants
n=5 Participants
|
3159 Participants
n=4 Participants
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11332 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20,632 Participants
n=5 Participants
|
26208 Participants
n=7 Participants
|
25002 Participants
n=5 Participants
|
29918 Participants
n=4 Participants
|
101760 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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204 Participants
n=5 Participants
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336 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
1144 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
517 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
55 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
432 Participants
n=21 Participants
|
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Race (NIH/OMB)
Black or African American
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5106 Participants
n=5 Participants
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2720 Participants
n=7 Participants
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5990 Participants
n=5 Participants
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3215 Participants
n=4 Participants
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17031 Participants
n=21 Participants
|
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Race (NIH/OMB)
White
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16343 Participants
n=5 Participants
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23832 Participants
n=7 Participants
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19893 Participants
n=5 Participants
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27323 Participants
n=4 Participants
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87391 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
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321 Participants
n=5 Participants
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403 Participants
n=7 Participants
|
389 Participants
n=5 Participants
|
467 Participants
n=4 Participants
|
1580 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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1096 Participants
n=5 Participants
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1229 Participants
n=7 Participants
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1337 Participants
n=5 Participants
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1335 Participants
n=4 Participants
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4997 Participants
n=21 Participants
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% of total visits prescribed an antimicrobial (monthly median)
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19.1 Percentage of visits prescribed an abx
n=5 Participants
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21.6 Percentage of visits prescribed an abx
n=7 Participants
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21.2 Percentage of visits prescribed an abx
n=5 Participants
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20.9 Percentage of visits prescribed an abx
n=4 Participants
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20.7 Percentage of visits prescribed an abx
n=21 Participants
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PRIMARY outcome
Timeframe: This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=61 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
Baseline
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21.2 percentage of visits prescribed an abx
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20.9 percentage of visits prescribed an abx
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Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
Intervention period
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19.1 percentage of visits prescribed an abx
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21.6 percentage of visits prescribed an abx
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SECONDARY outcome
Timeframe: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
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Patients Seen in the ED at Control Sites
n=61912 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
Baseline
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31.5 percentage of visits exposed to late abx
Interval 28.6 to 36.1
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29.5 percentage of visits exposed to late abx
Interval 26.5 to 31.9
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Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
Intervention
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31.1 percentage of visits exposed to late abx
Interval 28.6 to 35.8
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28.5 percentage of visits exposed to late abx
Interval 25.4 to 32.5
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SECONDARY outcome
Timeframe: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=61912 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
Baseline
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5.9 percentage of visits hospitalized
Interval 4.9 to 6.5
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5.6 percentage of visits hospitalized
Interval 4.9 to 6.1
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Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
Intervention period
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5.9 percentage of visits hospitalized
Interval 5.1 to 6.6
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5.8 percentage of visits hospitalized
Interval 5.2 to 6.3
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SECONDARY outcome
Timeframe: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=61912 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
Baseline
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0.56 percentage of patient-visits who died
Interval 0.4 to 0.7
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0.61 percentage of patient-visits who died
Interval 0.4 to 0.8
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Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
Intervention period
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0.60 percentage of patient-visits who died
Interval 0.4 to 0.7
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0.59 percentage of patient-visits who died
Interval 0.5 to 0.8
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SECONDARY outcome
Timeframe: For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=61912 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
|
|---|---|---|
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Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
Baseline
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0.60 percentage of visits tested
Interval 0.5 to 1.2
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0.86 percentage of visits tested
Interval 0.7 to 1.2
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Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
Intervention period
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0.69 percentage of visits tested
Interval 0.5 to 0.7
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0.89 percentage of visits tested
Interval 0.7 to 1.2
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SECONDARY outcome
Timeframe: For the baseline and intervention periods, this outcome will be reported as the percentage of patients who received guideline-concordant management among the sample of qualifying ED visits that were randomly selected for manual chart review.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods at intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=470 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=465 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
Baseline
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125 Participants
|
123 Participants
|
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Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
Intervention
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166 Participants
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131 Participants
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SECONDARY outcome
Timeframe: This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.Population: For the Outcome Measure Data Table shown below, patient-visits were stratified by period (i.e. baseline and intervention period), and outcomes were compared across these two periods between intervention and control sites. Please see our statistical analysis plan for further details. For the intervention and control sites, the "overall number of participants analyzed" in the Arms/Groups table equals the sum of the "number analyzed" for the baseline and intervention periods, as shown below.
This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Outcome measures
| Measure |
Patients Seen in the ED at Audit-and-feedback Sites
n=51180 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to have been exposed during the intervention.
|
Patients Seen in the ED at Control Sites
n=61912 Participants
All patients seen in the ED at audit-and-feedback sites will be considered to not have been exposed to the intervention.
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|---|---|---|
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Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
Baseline
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20.8 % of visits prescribed an antibiotic
Interval 19.6 to 21.8
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20.6 % of visits prescribed an antibiotic
Interval 18.7 to 22.2
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Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
Intervention
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18.2 % of visits prescribed an antibiotic
Interval 16.8 to 19.6
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20.6 % of visits prescribed an antibiotic
Interval 19.4 to 21.9
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Adverse Events
Patients Seen at Audit-and-feedback ED Sites During Intervention Period
Patients Seen at Control ED Sites During the Intervention Period
Patients Seen at Audit-and-feedback ED Sites During the Baseline Period
Patients Seen at Control EDs During the Baseline Period
Serious adverse events
| Measure |
Patients Seen at Audit-and-feedback ED Sites During Intervention Period
n=23164 participants at risk
All patients seen in the EDs undergoing the audit-and-feedback intervention will be considered to have been exposed to the intervention. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at intervention sites.
Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.
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Patients Seen at Control ED Sites During the Intervention Period
n=28835 participants at risk
All patients seen in the EDs designated as control sites will be considered to have been part of the control group. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at control sites.
Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.
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Patients Seen at Audit-and-feedback ED Sites During the Baseline Period
n=28016 participants at risk
For this adverse event reporting section, we are only reporting ED patient-visits at intervention sites during the baseline period.
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Patients Seen at Control EDs During the Baseline Period
n=33077 participants at risk
For this adverse event reporting section, we are reporting ED patient-visits at control sites during the baseline period.
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|---|---|---|---|---|
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General disorders
Hospitalization >24 hours after but within 30 days of ED visit
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6.3%
1452/23164 • Number of events 1452 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
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5.9%
1687/28835 • Number of events 1687 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
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5.9%
1664/28016 • Number of events 1664 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
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5.5%
1834/33077 • Number of events 1834 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
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General disorders
Mortality > 24 hours after ED visit and within 30 days of visit
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0.61%
141/23164 • Number of events 141 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
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0.61%
176/28835 • Number of events 176 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
0.52%
146/28016 • Number of events 146 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
0.60%
197/33077 • Number of events 197 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
Other adverse events
| Measure |
Patients Seen at Audit-and-feedback ED Sites During Intervention Period
n=23164 participants at risk
All patients seen in the EDs undergoing the audit-and-feedback intervention will be considered to have been exposed to the intervention. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at intervention sites.
Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.
|
Patients Seen at Control ED Sites During the Intervention Period
n=28835 participants at risk
All patients seen in the EDs designated as control sites will be considered to have been part of the control group. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at control sites.
Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper.
|
Patients Seen at Audit-and-feedback ED Sites During the Baseline Period
n=28016 participants at risk
For this adverse event reporting section, we are only reporting ED patient-visits at intervention sites during the baseline period.
|
Patients Seen at Control EDs During the Baseline Period
n=33077 participants at risk
For this adverse event reporting section, we are reporting ED patient-visits at control sites during the baseline period.
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|---|---|---|---|---|
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Gastrointestinal disorders
Clostridioides difficile infection
|
0.05%
11/23164 • Number of events 11 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
0.09%
27/28835 • Number of events 27 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
0.69%
193/28016 • Number of events 28016 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
0.97%
321/33077 • Number of events 33077 • Outcomes were tracked for 30 days after each ED patient visit.
Other adverse events consisted of Clostridioides difficile infections
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place