Anti-Bacterial Agents, Respiratory Tract Infections
Conditions
Brief summary
Antimicrobial resistance is one of today's most urgent public health problems. One of the most important strategies to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use. There are tremendous opportunities to reduce unnecessary antimicrobial-prescribing, particularly in Emergency Departments (EDs). In this study, the investigators will work collaboratively with ED providers in the Veterans Health Administration (VHA) to reduce unnecessary antimicrobial use. Academic-detailing and an audit-and-feedback intervention will be implemented, and the study will assess how overall antimicrobial-prescribing changes once these interventions are performed. ED providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions. To assess the impact of this intervention, the study will monitor providers' antimicrobial-prescribing behavior through an automated metric, i.e. number of antimicrobial prescriptions per number of patient-visits. To assess changes in the appropriateness of antimicrobial-prescribing, the study team will also perform manual chart reviews and compare prescribing decisions to published guidelines.
Detailed description
Using a quasi-experimental design, the study team will work collaboratively with ED providers in the Veterans Health Administration (VHA) to improve antimicrobial-prescribing. Academic-detailing and an audit-and-feedback intervention will be implemented. Through audit-and-feedback, providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions. The study will use a pretest-posttest design (quasi-experimental design with a non-equivalent control group) to assess the effect of our pilot intervention at 2 participating EDs and 2 control EDs. For each ED, the pretest period will be the 12 months prior to the intervention. The intervention itself will last 12 months. There will be an estimated 30 ED providers at the 2 study sites and 30 ED providers at the 2 control sites. Only antimicrobial prescriptions to patients discharged from the ED will be evaluated. The primary outcome will be antimicrobial-prescribing volume adjusted for the total number of patient-visits. Secondary outcomes include the frequency of guideline-discordant antimicrobial-prescribing and adverse events. At the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial usage for the 2 intervention sites combined and the 2 control sites combined. The time frame for this ITS analysis will be the one-year prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 24 months. In addition, a multivariable analysis will be performed to identify predictors of guideline-discordant therapy.
Interventions
BEHAVIORALAudit-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.
Sponsors
Merck Sharp & Dohme LLC
Iowa City Veterans Affairs Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
--An ED provider at one of the intervention or control sites.
Exclusion criteria
--An ED provider who sees less than 100 patients in the ED per year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit | 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. | 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. |
| Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit | 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. | Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit. |
| Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit | 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. | 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. |
| Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management | 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. | 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. |
| Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit | 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. | 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. |
| Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites During the Intervention Period These measures reflect patients seen at audit-and-feedback sites during the intervention period. | 23,164 |
| Patients Seen in the ED at Control Sites During the Intervention Period These baseline measures reflect patients seen at control sites during the intervention period. | 28,835 |
| Patients Seen in the ED at Audit-and-feedback Sites During the Baseline Period These measures reflect patients seen at audit-and-feedback sites before the intervention period, i.e. during the baseline period. | 28,016 |
| Patients Seen in the ED at Control Sites During the Baseline Period These measures reflect patients seen at control sites before the intervention period, i.e. during the baseline period. | 33,077 |
| Total | 113,092 |
Baseline characteristics
| Characteristic | Patients Seen in the ED at Audit-and-feedback Sites During the Intervention Period | Total | Patients Seen in the ED at Control Sites During the Baseline Period | Patients Seen in the ED at Audit-and-feedback Sites During the Baseline Period | Patients Seen in the ED at Control Sites During the Intervention Period |
|---|---|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 60 years | 60 years | 60 years |
| % of total visits prescribed an antimicrobial (monthly median) | 19.1 Percentage of visits prescribed an abx | 20.7 Percentage of visits prescribed an abx | 20.9 Percentage of visits prescribed an abx | 21.2 Percentage of visits prescribed an abx | 21.6 Percentage of visits prescribed an abx |
| Race (NIH/OMB) American Indian or Alaska Native | 204 Participants | 1144 Participants | 361 Participants | 243 Participants | 336 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 517 Participants | 218 Participants | 70 Participants | 190 Participants |
| Race (NIH/OMB) Black or African American | 5106 Participants | 17031 Participants | 3215 Participants | 5990 Participants | 2720 Participants |
| Race (NIH/OMB) More than one race | 321 Participants | 1580 Participants | 467 Participants | 389 Participants | 403 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 55 Participants | 432 Participants | 158 Participants | 94 Participants | 125 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1096 Participants | 4997 Participants | 1335 Participants | 1337 Participants | 1229 Participants |
| Race (NIH/OMB) White | 16343 Participants | 87391 Participants | 27323 Participants | 19893 Participants | 23832 Participants |
| Sex: Female, Male Female | 2532 Participants | 11332 Participants | 3159 Participants | 3014 Participants | 2627 Participants |
| Sex: Female, Male Male | 20,632 Participants | 101760 Participants | 29918 Participants | 25002 Participants | 26208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 141 / 23,164 | 176 / 28,835 | 146 / 28,016 | 197 / 33,077 |
| other Total, other adverse events | 11 / 23,164 | 27 / 28,835 | 193 / 28,016 | 321 / 33,077 |
| serious Total, serious adverse events | 1,593 / 23,164 | 1,863 / 28,835 | 1,810 / 28,016 | 2,031 / 33,077 |
Outcome results
Primary
Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit | Baseline | 21.2 percentage of visits prescribed an abx |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit | Intervention period | 19.1 percentage of visits prescribed an abx |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit | Baseline | 20.9 percentage of visits prescribed an abx |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit | Intervention period | 21.6 percentage of visits prescribed an abx |
p-value: 0.3595% CI: [0.98, 1.01]Mixed Models Analysis
Secondary
Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 31.5 percentage of visits exposed to late abx |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention | 31.1 percentage of visits exposed to late abx |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 29.5 percentage of visits exposed to late abx |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention | 28.5 percentage of visits exposed to late abx |
95% CI: [0.93, 1.35]
Secondary
Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit | Baseline | 20.8 % of visits prescribed an antibiotic |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit | Intervention | 18.2 % of visits prescribed an antibiotic |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit | Baseline | 20.6 % of visits prescribed an antibiotic |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit | Intervention | 20.6 % of visits prescribed an antibiotic |
p-value: 0.46Regression, Logistic
Secondary
Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 0.56 percentage of patient-visits who died |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 0.60 percentage of patient-visits who died |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 0.61 percentage of patient-visits who died |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 0.59 percentage of patient-visits who died |
95% CI: [0.58, 1.34]
Secondary
Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management | Baseline | 125 Participants |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management | Intervention | 166 Participants |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management | Baseline | 123 Participants |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management | Intervention | 131 Participants |
p-value: 0.001Chi-squared
p-value: 0.13Chi-squared
Secondary
Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 0.60 percentage of visits tested |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 0.69 percentage of visits tested |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 0.86 percentage of visits tested |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 0.89 percentage of visits tested |
95% CI: [0.53, 1.29]
Secondary
Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 5.9 percentage of visits hospitalized |
| Patients Seen in the ED at Audit-and-feedback Sites | Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 5.9 percentage of visits hospitalized |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit | Baseline | 5.6 percentage of visits hospitalized |
| Patients Seen in the ED at Control Sites | Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit | Intervention period | 5.8 percentage of visits hospitalized |
95% CI: [0.81, 1.27]