Respiratory Tract InfectionsMITIGATENCT03022929
A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings
A study testing Enhanced Antimicrobial Stewardship Commitment and Feedback in people with Respiratory Tract Infections, run by University of California, Davis at 3 sites in United States.
Trial summary
Inappropriate antibiotic use is a major public health concern. Excessive exposure to antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable adverse drug reactions, and increased healthcare utilization and cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Enhanced Antimicrobial Stewardship Commitment and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2017to 24 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinicians will be eligible for the study if they meet the following Inclusion Criteria:
- Must be a clinician at one of the study sites.
- Must treat adult and/or pediatric patients with an acute respiratory infections.
Individual patient encounters will be ineligible for analysis if they meet any of the following Exclusion Criteria:
- Medical co-morbidities that make acute respiratory infection (ARI) guidelines less likely to apply.
- Concomitant visit diagnoses indicating a non-ARI possible bacterial infection.
- Concomitant visit diagnoses indicating potentially antibiotic appropriate ARI. diagnoses or other ARI diagnoses suggestive of a bacterial infection.
- Visit occurred within 30 days of an earlier ARI diagnosis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
UC Davis Medical Center
Sacramento, California, 95817
UCLA Harbor Medical Center
Torrance, California, 90509
About this study
Inappropriate antibiotic use is a major public health concern. Excessive exposure to antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable adverse drug reactions, and increased healthcare utilization and cost. As antibiotic prescribing in emergency departments and urgent care centers remains unchecked, national professional organizations including the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of the United States, recommend expansion of antimicrobial stewardship to these ambulatory care settings. The goal of antimicrobial stewardship is to effectively promote judicious antibiotic use in all healthcare settings, yet stewardship programs have not achieved their potential in terms of either reach or effectiveness. Reach has been limited by implementation mostly in inpatient settings; at the same time, recent critical experiments in behavioral science suggest that the effectiveness of existing stewardship programs could be greatly augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and peer-to-peer comparisons.
Read the detailed description
In this proposed acute care project, the investigators will compare a package consisting of education for providers using existing materials from Center for Disease Control and Prevention's (CDC) GetSmart campaign adapted for the acute care setting led by a physician champion at each site (the adapted intervention), to a more intensive intervention that incorporates adapted GetSmart materials enhanced with individualized audit and feedback, peer comparisons, and behavioral nudges (the enhanced intervention). The comparative effectiveness of the enhanced intervention will be evaluated in a multicenter cluster randomized trial nested within a quasi-experimental study of acute care stewardship. The investigators' hypothesis is that both interventions will reduce inappropriate antibiotic prescribing for antibiotic nonresponsive acute respiratory infections (ARIs) in emergency departments and urgent care centers, but that the enhanced one will be more effective. The investigators will use an interrupted time series study design to measure the impact of their interventions against the baseline period of usual care as well as against seasonally-adjusted historical controls. The cluster randomized design for the two types of acute care stewardship interventions will allow measurement of the difference- in-differences in antibiotic prescribing rates for acute bronchitis, acute bronchiolitis, viral pharyngitis, influenza, and nonspecific upper respiratory infection (URI). Translation of proven behavioral techniques is a new and innovative approach to improving prescribing decisions. This project will expand stewardship to a new setting using innovative and effective approaches including the adaptation of behavioral techniques for emergency department (ED) and urgent care settings. The investigators will also further establish their research group as a network for developing novel tools, measuring outcomes for antimicrobial stewardship, and disseminating research findings through acute care setting-specific toolkits.
- Conditions
- Respiratory Tract Infections
- Being tested
- Enhanced Antimicrobial Stewardship Commitment 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.
Enhanced Antimicrobial Stewardship Commitment and FeedbackBehavioural
Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Intervention | No intervention | The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers. |
| Enhanced Intervention | Experimental | The investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of "top performer" or "not a top performer" based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention. Receives: Behavioral: Enhanced Antimicrobial Stewardship Commitment and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Prescribing Trends
The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa S May, MD,MSPH,MSHS, Principal investigator, Associate Professor and Director of Emergency Department Antibiotic Stewardship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022929
- Sponsor's protocol ID
- 986083
- Other IDs
- 971471
- Acronym
- MITIGATE
- Status last verified
- Dec 2018
- First submitted
- 11 Jan 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD planned.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings
- ClinicalTrials.gov ID
- NCT03022929
- Acronym / sponsor ID
- MITIGATE / 986083
- Conditions
- Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
Inappropriate antibiotic use is a major public health concern. Excessive exposure to antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable adverse drug reactions, and increased healthcare utilization and cost. As antibiotic prescribing in emergency departments and urgent care centers remains unchecked, national professional organizations including the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of the United States, recommend expansion of antimicrobial stewardship to these ambulatory care settings. The goal of antimicrobial stewardship is to effectively promote judicious antibiotic use in all healthcare settings, yet stewardship programs have not achieved their potential in terms of either reach or effectiveness. Reach has been limited by implementation mostly in inpatient settings; at the same time, recent critical experiments in behavioral science suggest that the effectiveness of existing stewardship programs could be greatly augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and peer-to-peer comparisons.
Detailed description
In this proposed acute care project, the investigators will compare a package consisting of education for providers using existing materials from Center for Disease Control and Prevention's (CDC) GetSmart campaign adapted for the acute care setting led by a physician champion at each site (the adapted intervention), to a more intensive intervention that incorporates adapted GetSmart materials enhanced with individualized audit and feedback, peer comparisons, and behavioral nudges (the enhanced intervention). The comparative effectiveness of the enhanced intervention will be evaluated in a multicenter cluster randomized trial nested within a quasi-experimental study of acute care stewardship. The investigators' hypothesis is that both interventions will reduce inappropriate antibiotic prescribing for antibiotic nonresponsive acute respiratory infections (ARIs) in emergency departments and urgent care centers, but that the enhanced one will be more effective. The investigators will use an interrupted time series study design to measure the impact of their interventions against the baseline period of usual care as well as against seasonally-adjusted historical controls. The cluster randomized design for the two types of acute care stewardship interventions will allow measurement of the difference- in-differences in antibiotic prescribing rates for acute bronchitis, acute bronchiolitis, viral pharyngitis, influenza, and nonspecific upper respiratory infection (URI). Translation of proven behavioral techniques is a new and innovative approach to improving prescribing decisions. This project will expand stewardship to a new setting using innovative and effective approaches including the adaptation of behavioral techniques for emergency department (ED) and urgent care settings. The investigators will also further establish their research group as a network for developing novel tools, measuring outcomes for antimicrobial stewardship, and disseminating research findings through acute care setting-specific toolkits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Intervention | No intervention | –The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers. |
| Enhanced Intervention | Experimental | Behavioral: Enhanced Antimicrobial Stewardship Commitment and FeedbackThe investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of "top performer" or "not a top performer" based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Enhanced Antimicrobial Stewardship Commitment and FeedbackGoes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon. | Behavioural | Enhanced Intervention |
Primary outcome
Antibiotic Prescribing Trends
Time frame: Up to 2 years
The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.
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 20 Dec 2018.
- Individual participant dataSharing planned: No. No IPD planned.
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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.
Larissa S May, MD,MSPH,MSHS principal investigator
Associate Professor and Director of Emergency Department Antibiotic Stewardship
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Antimicrobial Stewardship Commitment and Feedback in people with Respiratory Tract Infections, run by University of California, Davis at 3 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?
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 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 Trends (time frame: Up to 2 years). 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 20 Dec 2018.