Acute Respiratory Infections (ARIs)BEARINCT01454960
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
A study testing Clinical Decision Support: Accountable Justification, Audit and Feedback: Peer Comparison and CDS Order Sets: Suggested Alternatives in people with Acute Respiratory Infections (ARIs), run by University of Southern California at 1 site in United States.
Trial summary
Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant… 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?
- Clinical Decision Support: Accountable Justification, Audit and Feedback: Peer Comparison and CDS Order Sets: Suggested Alternatives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 2014
- 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
Who may be able to join
- A practicing attending physician or advanced practice nurse ("provider") at Northwestern University's NMFF GIM Clinic in 2011-2013 who sees acute respiratory infection patients.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
Chicago, Illinois, 60611-2923
About this study
Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices.
The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral.
Read more
The objective of this study is to improve provider decisions around treatment of acute respiratory infections.
The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study.
Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below.
There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time.
The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.
Read the detailed description
Each consented provider will be randomized to 1 of 8 cells in a factorial design with equal probability. If results of retrospective data analysis imply that design will be improved by stratification, randomization will be stratified by factors that could influence outcomes.
Data will be collected from Northwestern University's Enterprise Data Warehouse which houses copies of data recorded in the Epic electronic health record. Data elements from qualifying office visits will be collected from coded portions of the electronic health record.
An encounter is eligible for intervention if the patient's diagnosis is in the selected group of acute respiratory infections. The intervention EHR functions will be triggered when clinicians initiate an antibiotic prescription or enter a diagnosis for an acute respiratory infection that has a defined Order Set. If an antibiotic from a list of frequently misprescribed antibiotics is ordered and a diagnosis has not yet been entered, providers will be prompted to enter a diagnosis. If the diagnosis entered is acute nasopharyngitis; acute laryngeopharyngitis/acute upper respiratory infection; acute bronchitis; bronchitis not specified as acute or chronic; or flu; the interventions will be triggered. The diagnosis-appropriate order set will pop-up for providers in the Suggested Alternatives (SA) arm, while clinicians randomized to the Accountable Justification (AJ) arm will receive an alert and be required to enter a brief statement justifying their antibiotic prescription if antibiotics are not indicated for the diagnosis entered. This note will then be added to the patient's medical record.
Clinicians randomized to the Peer Comparison (PC) condition will receive monthly updates about their antibiotic prescribing practices relative to other clinicians in their practice.
- Conditions
- Acute Respiratory Infections (ARIs)
- Being tested
- Clinical Decision Support: Accountable Justification, Audit and Feedback: Peer Comparison, CDS Order Sets: Suggested Alternatives
- Keywords
- Antibiotics, Inappropriate Prescribing, Respiratory Tract Infections, Behavioral Research
- 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.
Clinical Decision Support: Accountable JustificationBehavioural
Also called AJ, Accountable Justification
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Audit and Feedback: Peer ComparisonBehavioural
Also called PC, Peer Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
CDS Order Sets: Suggested AlternativesBehavioural
Also called SA, Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
| Study group | Role | What they receive |
|---|---|---|
| SA, AJ, PC | Experimental | Participants are given all 3 interventions:
Suggested Alternatives, Accountable Justification, and Peer Comparison. Receives: Behavioral: Clinical Decision Support: Accountable Justification; Behavioral: Audit and Feedback: Peer Comparison; Behavioral: CDS Order Sets: Suggested Alternatives |
| SA, AJ | Experimental | Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. Receives: Behavioral: Clinical Decision Support: Accountable Justification; Behavioral: CDS Order Sets: Suggested Alternatives |
| SA, PC | Experimental | Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention. Receives: Behavioral: Audit and Feedback: Peer Comparison; Behavioral: CDS Order Sets: Suggested Alternatives |
| AJ, PC | Experimental | Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention. Receives: Behavioral: Clinical Decision Support: Accountable Justification; Behavioral: Audit and Feedback: Peer Comparison |
| Peer Comparison | Experimental | Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. Receives: Behavioral: Audit and Feedback: Peer Comparison |
| Suggested Alternatives | Experimental | Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. Receives: Behavioral: CDS Order Sets: Suggested Alternatives |
| Accountable Justification | Experimental | Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. Receives: Behavioral: Clinical Decision Support: Accountable Justification |
| Control | No intervention | Participants do not receive any of the 3 interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
Changes in antibiotic prescribing rate for the following ICD-9 diagnoses:
460 Acute nasopharyngitis (common cold)
465 Acute laryngeopharyngitis/acute upper respiratory infection
466 Acute bronchitis
490 Bronchitis not specified as acute or chronic
487 Flu
Measured: 2 years
Secondary outcomes (1)
Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- More trials run by University of Southern CaliforniaThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Stephen Persell, MD, Principal investigator, Northwestern UniversityJason N Doctor, PhD, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454960
- Sponsor's protocol ID
- 1RC4AG039115-01-2
- Other IDs
- 1RC4AG039115-01
- Acronym
- BEARI
- Status last verified
- Mar 2017
- First submitted
- 4 Aug 2011
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Persell SD, Doctor JN, Friedberg MW, Meeker D, Friesema E, Cooper A, Haryani A, Gregory DL, Fox CR, Goldstein NJ, Linder JA. Behavioral interventions to reduce inappropriate antibiotic prescribing: a randomized pilot trial. BMC Infect Dis. 2016 Aug 5;16:373. doi: 10.1186/s12879-016-1715-8.
PubMed 27495917
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
- ClinicalTrials.gov ID
- NCT01454960
- Acronym / sponsor ID
- BEARI / 1RC4AG039115-01-2
- Conditions
- Acute Respiratory Infections (ARIs)
- Keywords
- Antibiotics, Inappropriate Prescribing, Respiratory Tract Infections, Behavioral Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Oct 2011 (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.
Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices.
The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral.
The objective of this study is to improve provider decisions around treatment of acute respiratory infections.
The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study.
Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below.
There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time.
The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.
Detailed description
Each consented provider will be randomized to 1 of 8 cells in a factorial design with equal probability. If results of retrospective data analysis imply that design will be improved by stratification, randomization will be stratified by factors that could influence outcomes.
Data will be collected from Northwestern University's Enterprise Data Warehouse which houses copies of data recorded in the Epic electronic health record. Data elements from qualifying office visits will be collected from coded portions of the electronic health record.
An encounter is eligible for intervention if the patient's diagnosis is in the selected group of acute respiratory infections. The intervention EHR functions will be triggered when clinicians initiate an antibiotic prescription or enter a diagnosis for an acute respiratory infection that has a defined Order Set. If an antibiotic from a list of frequently misprescribed antibiotics is ordered and a diagnosis has not yet been entered, providers will be prompted to enter a diagnosis. If the diagnosis entered is acute nasopharyngitis; acute laryngeopharyngitis/acute upper respiratory infection; acute bronchitis; bronchitis not specified as acute or chronic; or flu; the interventions will be triggered. The diagnosis-appropriate order set will pop-up for providers in the Suggested Alternatives (SA) arm, while clinicians randomized to the Accountable Justification (AJ) arm will receive an alert and be required to enter a brief statement justifying their antibiotic prescription if antibiotics are not indicated for the diagnosis entered. This note will then be added to the patient's medical record.
Clinicians randomized to the Peer Comparison (PC) condition will receive monthly updates about their antibiotic prescribing practices relative to other clinicians in their practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SA, AJ, PC | Experimental | Behavioral: Clinical Decision Support: Accountable Justification, Behavioral: Audit and Feedback: Peer Comparison, Behavioral: CDS Order Sets: Suggested AlternativesParticipants are given all 3 interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison. |
| SA, AJ | Experimental | Behavioral: Clinical Decision Support: Accountable Justification, Behavioral: CDS Order Sets: Suggested AlternativesParticipants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. |
| SA, PC | Experimental | Behavioral: Audit and Feedback: Peer Comparison, Behavioral: CDS Order Sets: Suggested AlternativesParticipants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention. |
| AJ, PC | Experimental | Behavioral: Clinical Decision Support: Accountable Justification, Behavioral: Audit and Feedback: Peer ComparisonParticipants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention. |
| Peer Comparison | Experimental | Behavioral: Audit and Feedback: Peer ComparisonParticipants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. |
| Suggested Alternatives | Experimental | Behavioral: CDS Order Sets: Suggested AlternativesParticipants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. |
| Accountable Justification | Experimental | Behavioral: Clinical Decision Support: Accountable JustificationParticipants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. |
| Control | No intervention | –Participants do not receive any of the 3 interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A practicing attending physician or advanced practice nurse ("provider") at Northwestern University's NMFF GIM Clinic in 2011-2013 who sees acute respiratory infection patients.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clinical Decision Support: Accountable JustificationAlso: AJ, Accountable JustificationAccountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ). | Behavioural | AJ, PC, Accountable Justification, SA, AJ, SA, AJ, PC |
| Audit and Feedback: Peer ComparisonAlso: PC, Peer ComparisonPerformance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison). | Behavioural | AJ, PC, Peer Comparison, SA, AJ, PC, SA, PC |
| CDS Order Sets: Suggested AlternativesAlso: SA, Suggested AlternativesOrder Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives). | Behavioural | SA, AJ, SA, AJ, PC, SA, PC, Suggested Alternatives |
Primary outcome
Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
Time frame: 2 years
Changes in antibiotic prescribing rate for the following ICD-9 diagnoses: 460 Acute nasopharyngitis (common cold) 465 Acute laryngeopharyngitis/acute upper respiratory infection 466 Acute bronchitis 490 Bronchitis not specified as acute or chronic 487 Flu
1 secondary outcome
Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
Time frame: 2 years
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 4 Apr 2017.
- Derived from this study: PubMed 27495917Persell SD, Doctor JN, Friedberg MW, Meeker D, Friesema E, Cooper A, Haryani A, Gregory DL, Fox CR, Goldstein NJ, Linder JA. Behavioral interventions to reduce inappropriate antibiotic prescribing: a randomized pilot trial. BMC Infect Dis. 2016 Aug 5;16:373. doi: 10.1186/s12879-016-1715-8.
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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.
Stephen Persell, MD principal investigator
Northwestern University
Jason N Doctor, PhD study director
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 Clinical Decision Support: Accountable Justification, Audit and Feedback: Peer Comparison and CDS Order Sets: Suggested Alternatives 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 1 inclusion and 0 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 4 Apr 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?
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 Rate for 5 Specific Acute Respiratory Infection Diagnoses (time frame: 2 years). 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 NCT01454960, 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 4 Apr 2017.