Anti-Bacterial AgentsNCT03349567

Improving Antimicrobial-Prescribing in Emergency Departments

A study testing Audit-and-feedback in people with Anti-Bacterial Agents and Respiratory Tract Infections, run by Iowa City Veterans Affairs Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Anti-Bacterial Agents, Respiratory Tract Infections
What is being tested?: Audit-and-feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: 9 Oct 2018to 31 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

--An ED provider at one of the intervention or control sites.

Who cannot join

--An ED provider who sees less than 100 patients in the ED per year.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Richard Roudebush VAMC
Indianapolis, Indiana, 46202
Sioux Falls VA
Sioux Falls, South Dakota, 57105

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About this study

Official title: The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study

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.

Read the 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.

Conditions: Anti-Bacterial Agents, Respiratory Tract Infections
Being tested: Audit-and-feedback
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Audit-and-feedbackBehavioural
Also called Academic detailing
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.

Study groups in NCT03349567
Study group	Role	What they receive
Audit-and-feedback	Experimental	The experimental arm will consist of Emergency Department providers who do receive the intervention. Receives: Behavioral: Audit-and-feedback
Control	No intervention	The control arm will consist of providers who do not receive the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Secondary outcomes (6)

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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201831 Oct 2019

First posted21 Nov 2017
Study start9 Oct 2018
Primary completion30 Sep 2019
Study completion31 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anti-Bacterial AgentsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03349567
Sponsor's protocol ID: 201708772
Status last verified: Apr 2021
First submitted: 17 Nov 2017
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
ClinicalTrials.gov ID: NCT03349567
Acronym / sponsor ID: 201708772
Conditions: Anti-Bacterial Agents, Respiratory Tract Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Iowa City Veterans Affairs Medical CenterUS federal agency
Collaborators: Merck Sharp & Dohme LLC
Study start: 9 Oct 2018 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 31 Oct 2019 (actual)
First posted: 21 Nov 2017 (actual)
Results: Posted 28 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Audit-and-feedback	Experimental	Behavioral: Audit-and-feedbackThe experimental arm will consist of Emergency Department providers who do receive the intervention.
Control	No intervention	–The control arm will consist of providers who do not receive the intervention.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

--An ED provider at one of the intervention or control sites.

Key exclusion criteria (1 listed)

--An ED provider who sees less than 100 patients in the ED per year.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Audit-and-feedbackAlso: Academic detailingWe 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.	Behavioural	Audit-and-feedback

Primary outcome

Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
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.
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.

6 secondary outcomes

Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their 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.
Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their 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.
Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their 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.
Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their 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.
Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
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.
Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
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.

Results and safety

Results posted to the registry on 28 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Audit-and-feedback	2	2
Control	2	2

Primary outcome: Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit

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.. Number. Unit: percentage of visits prescribed an abx

Measure	Patients Seen in the ED at Audit-and-feedback Sites n = 51180	Patients Seen in the ED at Control Sites n = 61,912
Baseline	21.2	20.9
Intervention period	19.1	21.6

Patients Seen in the ED at Audit-and-feedback Sites vs Patients Seen in the ED at Control Sites: Incident rate ratio: 0.99 (95% CI 0.98 to 1.01), p = 0.35, Mixed Models Analysis

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Outcomes were tracked for 30 days after each ED patient visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Seen at Audit-and-feedback ED Sites During Intervention Period	1,593 of 23,164 (6.9%)	11 of 23,164 (0%)	141 of 23,164
Patients Seen at Control ED Sites During the Intervention Period	1,863 of 28,835 (6.5%)	27 of 28,835 (0.1%)	176 of 28,835
Patients Seen at Audit-and-feedback ED Sites During the Baseline Period	1,810 of 28,016 (6.5%)	193 of 28,016 (0.7%)	146 of 28,016
Patients Seen at Control EDs During the Baseline Period	2,031 of 33,077 (6.1%)	321 of 33,077 (1%)	197 of 33,077

Limitations and caveats (from the sponsor): Because the study was not randomized, we cannot exclude temporal confounding or selection bias. By conducting a time-series analysis, we tried to account for confounders that may change over time, and by including a matched-control group, we tried to minimize the possibility of regression to the mean. Second, we cannot exclude the possibility that sites had any other processes in place that could have influenced our outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Audit-and-feedback in people with Anti-Bacterial Agents and Respiratory Tract Infections, run by Iowa City Veterans Affairs Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03349567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.