Acute Respiratory Infections (ARIs)NCT01767064
Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments
A study testing Posted commitment letter in people with Acute Respiratory Infections (ARIs), run by University of Southern California at 1 site in United States.
Trial summary
Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite decades of intervention efforts. Negative outcomes of inappropriate antibiotics include increased costs of care, adverse drug reactions, and rising prevalence of antibiotic-resistant bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Infections (ARIs)
- What is being tested?
- Posted commitment letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical professionals licensed to provide care and prescribe medications (including antibiotics)
- Treating adult patients (18 years of age and older) from 5 Los Angeles community clinics
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
QueensCare Family Clinics
Los Angeles, California, 90027
About this study
Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite decades of intervention efforts. Negative outcomes of inappropriate antibiotics include increased costs of care, adverse drug reactions, and rising prevalence of antibiotic-resistant bacteria. To address this public health problem, we apply the principles of commitment and consistency in an effort to influence clinician decision-making through the implementation of a low-cost behavioral "nudge" in the form of a simple public commitment device. Clinicians were asked to post in their exam room a signed letter indicating their commitments to reducing inappropriate antibiotic use for ARIs. Our hypothesis is that clinicians displaying the poster-sized commitment letters will decrease their inappropriate antibiotic prescribing for ARIs as compared to clinicians in the control condition (with no posted letter).
- Conditions
- Acute Respiratory Infections (ARIs)
- Being tested
- Posted commitment letter
- Keywords
- ARIs, antibiotics, public commitment, quality improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posted commitment letterOther
| Study group | Role | What they receive |
|---|---|---|
| Posted commitment letter | Experimental | The poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period. Receives: Other: Posted commitment letter |
| Control | No intervention | Usual care with no posted letters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)
Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).
Measured: up to 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Infections (ARIs)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Jason N Doctor, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767064
- Sponsor's protocol ID
- USCalifornia
- Other IDs
- RC4AG039115
- Status last verified
- Jul 2017
- First submitted
- 10 Jan 2013
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 24474434
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments
- ClinicalTrials.gov ID
- NCT01767064
- Acronym / sponsor ID
- USCalifornia
- Conditions
- Acute Respiratory Infections (ARIs)
- Keywords
- ARIs, antibiotics, public commitment, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite decades of intervention efforts. Negative outcomes of inappropriate antibiotics include increased costs of care, adverse drug reactions, and rising prevalence of antibiotic-resistant bacteria. To address this public health problem, we apply the principles of commitment and consistency in an effort to influence clinician decision-making through the implementation of a low-cost behavioral "nudge" in the form of a simple public commitment device. Clinicians were asked to post in their exam room a signed letter indicating their commitments to reducing inappropriate antibiotic use for ARIs. Our hypothesis is that clinicians displaying the poster-sized commitment letters will decrease their inappropriate antibiotic prescribing for ARIs as compared to clinicians in the control condition (with no posted letter).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posted commitment letter | Experimental | Other: Posted commitment letterThe poster-sized (18x24 inches) commitment letter, written at the 8th grade reading-level and displayed in English and Spanish, emphasize clinician commitment to guidelines for appropriate antibiotic prescribing and explain why antibiotics are not appropriate in many cases. These letters, featuring clinician photographs and signatures, are displayed in clinician exam rooms for a 16-week period. |
| Control | No intervention | –Usual care with no posted letters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical professionals licensed to provide care and prescribe medications (including antibiotics)
- Treating adult patients (18 years of age and older) from 5 Los Angeles community clinics
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Posted commitment letter | Other | Posted commitment letter |
Primary outcome
Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)
Time frame: up to 12 months post intervention
Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
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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.
Jason N Doctor, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posted commitment letter in people with Acute Respiratory Infections (ARIs), run by University of Southern California 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 2 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 10 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2017). 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?
Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI) (time frame: up to 12 months post intervention). 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 NCT01767064, which also lists 1 linked publication.
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 10 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.