AntibioticsNCT03464279
Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections
A study testing Nudge using Behavioral Economic Interventions and Standard Practices to Reduce Health System Antibiotic Prescription in people with Antibiotics and Upper Respiratory Infections, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotics, Upper Respiratory Infections, Safety-Net Hospitals
- What is being tested?
- Nudge using Behavioral Economic Interventions and Standard Practices to Reduce Health System Antibiotic Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2015to 30 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patient receiving treatment for Upper Respiratory Infections (defined by ICD codes EHR billable codes) at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center
Who cannot join
- Patients not receiving treatment for Upper Respiratory Infections at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County +University of Southern California (LAC+USC) Medical Center
Los Angeles, California, 90033
About this study
In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will used to test the effects of behavioral "nudge" on antibiotic prescribing.
Read the detailed description
National prescription rates for low-value antibiotics for uncomplicated upper respiratory infections (URIs) remain unacceptably high, including at LAC+USC Medical Center-one of the largest safety net medical centers in the U.S. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will be compared. A three-part intervention at LAC+USC consists of (1) the urgent care medical director emailing Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, and then (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs, which will be displayed in the clinic. In contrast, the control site (Urgent Care Center at Olive View-Medical Center) will receive Centers for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics, in a broader health system effort to reduce antibiotic prescribing. Patient with URIs (e.g., acute bronchitis, bronchitis NOS, excluding guideline-based red flags such as COPD, HIV) will be identified using electronic health record clinical billable data and low-value antibiotic prescriptions rates per visit will be monitored at both sites. Differences in prescriptions rates will be determined using an interrupted time-series analysis comparing utilization between sites using a repeated measures logistic regression model.
.
- Conditions
- Antibiotics, Upper Respiratory Infections, Safety-Net Hospitals, Behavioral Economics, Choosing Wisely
- Being tested
- Nudge using Behavioral Economic Interventions, Standard Practices to Reduce Health System Antibiotic Prescription
- 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.
Nudge using Behavioral Economic InterventionsBehavioural
Standard Practices to Reduce Health System Antibiotic PrescriptionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site | Experimental | The intervention Site (Urgent Care Center at LAC+USC Medical Center) will receive a three part intervention consisting of (1) Email Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs displayed in the clinic. Receives: Behavioral: Nudge using Behavioral Economic Interventions |
| Control Site | Active comparator | The control site (Urgent Care Center at Olive View-Medical Center) will receive broader health system efforts to reduce antibiotic prescribing consisting of Center for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics. Receives: Behavioral: Standard Practices to Reduce Health System Antibiotic Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Low-value antibiotic prescriptions rates per visit
Changes in inappropriate antibiotic prescriptions rates per visit before and after implementation of intervention at both sites
Measured: 1 year
Secondary outcomes (1)
Coding Shift (ie, a shift in use of diagnostic codes to conditions that are more antibiotic appropriate) in URI diagnosis
Change frequency of proportion of antibiotic appropriate diagnoses before intervention and after at both sites.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start29 May 2015
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- LAC+USC Medical Center, Los Angeles County Department of Public Health
- Responsible party
- Principal investigator, Catherine A. Sarkisian, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464279
- Sponsor's protocol ID
- IRB #16-000932-004
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meeker D, Knight TK, Friedberg MW, Linder JA, Goldstein NJ, Fox CR, Rothfeld A, Diaz G, Doctor JN. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):425-31. doi: 10.1001/jamainternmed.2013.14191.
PubMed 24474434Gonzales R, Steiner JF, Lum A, Barrett PH Jr. Decreasing antibiotic use in ambulatory practice: impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA. 1999 Apr 28;281(16):1512-9. doi: 10.1001/jama.281.16.1512.
PubMed 10227321
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections
- ClinicalTrials.gov ID
- NCT03464279
- Acronym / sponsor ID
- IRB #16-000932-004
- Conditions
- Antibiotics, Upper Respiratory Infections, Safety-Net Hospitals, Behavioral Economics, Choosing Wisely
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- LAC+USC Medical Center, Los Angeles County Department of Public Health
- Study start
- 29 May 2015 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 14 Mar 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.
In an effort to implement Choosing Wisely guidelines and decrease patient harm, we will implement and evaluate a clinician audit-feedback and behavioral "nudge" initiative to reduce low-value antibiotics for URIs. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will used to test the effects of behavioral "nudge" on antibiotic prescribing.
Detailed description
National prescription rates for low-value antibiotics for uncomplicated upper respiratory infections (URIs) remain unacceptably high, including at LAC+USC Medical Center-one of the largest safety net medical centers in the U.S. Using a quasi-experiment (pre-post) design, antibiotic prescriptions for URI at LAC+USC Urgent Care Center (intervention site) vs. Olive View-UCLA Urgent Care Center (control site) will be compared. A three-part intervention at LAC+USC consists of (1) the urgent care medical director emailing Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, and then (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs, which will be displayed in the clinic. In contrast, the control site (Urgent Care Center at Olive View-Medical Center) will receive Centers for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics, in a broader health system effort to reduce antibiotic prescribing. Patient with URIs (e.g., acute bronchitis, bronchitis NOS, excluding guideline-based red flags such as COPD, HIV) will be identified using electronic health record clinical billable data and low-value antibiotic prescriptions rates per visit will be monitored at both sites. Differences in prescriptions rates will be determined using an interrupted time-series analysis comparing utilization between sites using a repeated measures logistic regression model.
.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Site | Experimental | Behavioral: Nudge using Behavioral Economic InterventionsThe intervention Site (Urgent Care Center at LAC+USC Medical Center) will receive a three part intervention consisting of (1) Email Choosing Wisely® guidelines and presented journal club to all 16 urgent care clinicians, (2) leveraging EHR performance data to provide individual clinicians with case-specific audit-feedback (both via emails and in-person while precepting nurse practitioners) on low-value antibiotic prescribing, and (3) using a behavioral "nudge", urgent care clinicians will sign a large poster committing to avoid prescribing low-value antibiotics for uncomplicated URIs displayed in the clinic. |
| Control Site | Active comparator | Behavioral: Standard Practices to Reduce Health System Antibiotic PrescriptionThe control site (Urgent Care Center at Olive View-Medical Center) will receive broader health system efforts to reduce antibiotic prescribing consisting of Center for Disease Control prescription pads for non-antibiotic treatments (e.g., decongestants) that offer patients alternatives to antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient receiving treatment for Upper Respiratory Infections (defined by ICD codes EHR billable codes) at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center
Key exclusion criteria (1 listed)
- Patients not receiving treatment for Upper Respiratory Infections at both LAC+USC Medical Center Urgent Care or Olive View-UCLA Medical Center
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 |
|---|---|---|
| Nudge using Behavioral Economic Interventions | Behavioural | Intervention Site |
| Standard Practices to Reduce Health System Antibiotic Prescription | Behavioural | Control Site |
Primary outcome
Change in Low-value antibiotic prescriptions rates per visit
Time frame: 1 year
Changes in inappropriate antibiotic prescriptions rates per visit before and after implementation of intervention at both sites
1 secondary outcome
Coding Shift (ie, a shift in use of diagnostic codes to conditions that are more antibiotic appropriate) in URI diagnosis
Time frame: 1 year
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 2 May 2018.
- Background: PubMed 24474434Meeker D, Knight TK, Friedberg MW, Linder JA, Goldstein NJ, Fox CR, Rothfeld A, Diaz G, Doctor JN. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med. 2014 Mar;174(3):425-31. doi: 10.1001/jamainternmed.2013.14191.
- Background: PubMed 10227321Gonzales R, Steiner JF, Lum A, Barrett PH Jr. Decreasing antibiotic use in ambulatory practice: impact of a multidimensional intervention on the treatment of uncomplicated acute bronchitis in adults. JAMA. 1999 Apr 28;281(16):1512-9. doi: 10.1001/jama.281.16.1512.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge using Behavioral Economic Interventions and Standard Practices to Reduce Health System Antibiotic Prescription in people with Antibiotics and Upper Respiratory Infections, run by University of California, Los Angeles 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 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 2 May 2018. 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?
Change in Low-value antibiotic prescriptions rates per visit (time frame: 1 year). 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 NCT03464279, which also lists 2 linked publications.
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 2 May 2018.