Antimicrobial StewardshipNCT03711292
Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
A study testing Antibiotic Stewardship in people with Antimicrobial Stewardship and Acute Bronchitis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
Stepped wedge behavioral intervention clinical trial looking at the impact of an antibiotic stewardship intervention on provider prescribing behavior for acute respiratory infections (ARIs), where the intervention is administered at the emergency department or urgent care center site level, using a cluster… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Antimicrobial Stewardship, Acute Bronchitis, Upper Respiratory Infection
- What is being tested?
- Antibiotic Stewardship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribing provider in an adult emergency department or urgent care center in the Los Angeles County Department of Health Services.
- Treated at a Los Angeles County Department of Health Services facility with an ARI diagnosis
- Cared for by a provider and in practice site enrolled in the study
- Visit occurred during the 12-month intervention period, or the 12-month historical baseline period
- Did not have a visit with any ARI diagnosis in the prior 30 days
Who cannot join
- Provider has not treated a patient with an ARI
- Eligibility (patient)
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health Services
Los Angeles, California, 90012
About this study
Stepped wedge behavioral intervention clinical trial looking at the impact of an antibiotic stewardship intervention on provider prescribing behavior for acute respiratory infections (ARIs), where the intervention is administered at the emergency department or urgent care center site level, using a cluster randomization process. Thus, every site and every provider are eligible to be exposed to the stewardship intervention, the cluster randomized stepped wedge process simply randomizes when they will be exposed. The overall study hypothesis is that providers will prescribe fewer unnecessary antibiotics to patients with ARIs after the intervention.
Read the detailed description
Hypothesis: The primary hypothesis is that acute care ambulatory settings randomized to receive behavioral economic stewardship interventions will have decreased antibiotic prescribing rates for non-antibiotic appropriate ARIs, compared to contemporaneous antibiotic prescribing rates for non-antibiotic appropriate ARIs among control practices. This hypothesis will be evaluated in a linear mixed effects model will be used to estimate and test the group effect using group and time as fixed effects and practice site and provider as random effects. The interaction between time and group will be included to estimate and test the different group effect over time.
Design: The investigators will conduct a stepped wedge cluster randomized trial of acute care ambulatory visits to emergency departments and urgent care centers in a predominantly non-academic public hospital system. Clustering (by site) helps prevent treatment contamination between individual clinicians within the same site. The stepped wedge design will allow studying the effects of a complex intervention rolled out through a system over time, as often happens in the real-world, where State and Federal public health as well as site-based organization quality improvement interventions may be occurring at different times.
Treatment Assignment Procedures: For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with Centers for Disease Control and Prevention (CDC) core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
- Being tested
- Antibiotic Stewardship
- Keywords
- Emergency Department, Urgent Care Center, Behavioral Sciences
- Medical subject headings
- Bronchitis, Respiratory Tract Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic StewardshipBehavioural
For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with CDC core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Wedge Cluster Randomized | Experimental | Antibiotic stewardship intervention Receives: Behavioral: Antibiotic Stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescribing
The primary outcome measure is the rate of antibiotic prescribing for non-antibiotic-appropriate acute respiratory infections or in other words, acute respiratory infections that are presumed to be viral in nature. The International Classification of Diseases (ICD)-10 codes for primary outcomes are defined in detail in the clinical trials protocol document. These outcomes are computable clinical quality measures from the electronic health record. These are widely used in medicine to evaluate quality improvement and reliability and validity are generally supported.
Visits are excluded from the primary analysis when: 1) patients have certain medical co-morbidities that make ARI guidelines less likely to apply, 2) patients had concomitant visit diagnoses indicating a non-ARI possible bacterial infection, or 3) patients had concomitant visit diagnoses indicating potentially antibiotic appropriate ARI diagnoses or other ARI diagnoses suggestive of a bacterial infection.
Measured: 12 months
Secondary outcomes (1)
Diagnostic drift
Throughout the course of the study, the investigators will also be monitoring "diagnostic drift" that may result in provider shifting diagnosis to avoid guideline conflicts that might trigger poor performance reports. An auditing program will measure diagnostic deviation from each clinician's historical rates of diagnosing acute respiratory infections.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start7 Sep 2018
- Primary completion28 Feb 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial StewardshipStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Kabir Yadav, MDCM MS MSHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711292
- Sponsor's protocol ID
- 31429-01
- Other IDs
- UL1TR001881
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings
- ClinicalTrials.gov ID
- NCT03711292
- Acronym / sponsor ID
- 31429-01
- Keywords
- Emergency Department, Urgent Care Center, Behavioral Sciences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health, University of California, Los Angeles
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stepped wedge behavioral intervention clinical trial looking at the impact of an antibiotic stewardship intervention on provider prescribing behavior for acute respiratory infections (ARIs), where the intervention is administered at the emergency department or urgent care center site level, using a cluster randomization process. Thus, every site and every provider are eligible to be exposed to the stewardship intervention, the cluster randomized stepped wedge process simply randomizes when they will be exposed. The overall study hypothesis is that providers will prescribe fewer unnecessary antibiotics to patients with ARIs after the intervention.
Detailed description
Hypothesis: The primary hypothesis is that acute care ambulatory settings randomized to receive behavioral economic stewardship interventions will have decreased antibiotic prescribing rates for non-antibiotic appropriate ARIs, compared to contemporaneous antibiotic prescribing rates for non-antibiotic appropriate ARIs among control practices. This hypothesis will be evaluated in a linear mixed effects model will be used to estimate and test the group effect using group and time as fixed effects and practice site and provider as random effects. The interaction between time and group will be included to estimate and test the different group effect over time.
Design: The investigators will conduct a stepped wedge cluster randomized trial of acute care ambulatory visits to emergency departments and urgent care centers in a predominantly non-academic public hospital system. Clustering (by site) helps prevent treatment contamination between individual clinicians within the same site. The stepped wedge design will allow studying the effects of a complex intervention rolled out through a system over time, as often happens in the real-world, where State and Federal public health as well as site-based organization quality improvement interventions may be occurring at different times.
Treatment Assignment Procedures: For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with Centers for Disease Control and Prevention (CDC) core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Stepped Wedge Cluster Randomized | Experimental | Behavioral: Antibiotic StewardshipAntibiotic stewardship intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prescribing provider in an adult emergency department or urgent care center in the Los Angeles County Department of Health Services.
- Treated at a Los Angeles County Department of Health Services facility with an ARI diagnosis
- Cared for by a provider and in practice site enrolled in the study
- Visit occurred during the 12-month intervention period, or the 12-month historical baseline period
- Did not have a visit with any ARI diagnosis in the prior 30 days
Key exclusion criteria (3 listed)
- Provider has not treated a patient with an ARI
- Eligibility (patient)
- None
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 |
|---|---|---|
| Antibiotic StewardshipFor the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with CDC core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs. | Behavioural | Stepped Wedge Cluster Randomized |
Primary outcome
Antibiotic prescribing
Time frame: 12 months
The primary outcome measure is the rate of antibiotic prescribing for non-antibiotic-appropriate acute respiratory infections or in other words, acute respiratory infections that are presumed to be viral in nature. The International Classification of Diseases (ICD)-10 codes for primary outcomes are defined in detail in the clinical trials protocol document. These outcomes are computable clinical quality measures from the electronic health record. These are widely used in medicine to evaluate quality improvement and reliability and validity are generally supported. Visits are excluded from the primary analysis when: 1) patients have certain medical co-morbidities that make ARI guidelines less likely to apply, 2) patients had concomitant visit diagnoses indicating a non-ARI possible bacterial infection, or 3) patients had concomitant visit diagnoses indicating potentially antibiotic appropriate ARI diagnoses or other ARI diagnoses suggestive of a bacterial infection.
1 secondary outcome
Diagnostic drift
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Antimicrobial Stewardship
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Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Enrolling by invitation
VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
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RecruitingPhase 4
Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases
Autoimmune Rheumatic Diseases, Tooth Extraction
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.
Kabir Yadav, MDCM MS MSHS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic Stewardship in people with Antimicrobial Stewardship and Acute Bronchitis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site 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 5 inclusion and 3 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antibiotic prescribing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2023.