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Acute Respiratory Infections (ARIs)BEARINCT01454947

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study)

A study testing Clinical Decision Support (CDS): Accountable Justifications, 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 55 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 (CDS): Accountable Justifications, Audit and Feedback: Peer Comparison and CDS Order Sets: Suggested Alternatives
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
55 sitesUnited States
Study dates
Aug 2011to Sep 2014
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

  • A practicing attending physician or advanced practice nurse ("provider") at a participating clinic in 2011-2013 who sees acute respiratory infection patients.

Who cannot join

  • None.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites
  • Altamed Anaheim Lincoln

    Anaheim, California, 92801

  • Altamed Anaheim West

    Anaheim, California, 92801

  • Altamed Bell Clinic

    Bell, California, 90201

  • Brigham and Women's Primary Care Associates at Foxborough

    Boston, Massachusetts, 02035

  • MGH Downtown

    Boston, Massachusetts, 02108

  • Mass General Medial Group

    Boston, Massachusetts, 02114

  • MGH Beacon Hill

    Boston, Massachusetts, 02114

  • MGH Senior Health

    Boston, Massachusetts, 02114

  • Women's Health Associates

    Boston, Massachusetts, 02114

  • Brigham Circle Medical Associates

    Boston, Massachusetts, 02115

  • Brigham Internal Medicine Associates

    Boston, Massachusetts, 02115

  • Spanish Clinic

    Boston, Massachusetts, 02115

  • MGH Back Bay

    Boston, Massachusetts, 02228

  • Brigham and Women's Primary Care Associates of Brookline

    Brookline, Massachusetts, 02446

  • MGH Charlestown HealthCare Center

    Charlestown, Massachusetts, 02129

  • MGH Chelsea HealthCare Center

    Chelsea, Massachusetts, 02150

  • Brigham and Women's Physician Group

    Chestnut Hill, Massachusetts, 02467

  • Gretchen and Edward Fish Center for Women's Health

    Chestnut Hill, Massachusetts, 02467

  • Altamed Mobile Unit Primary Care

    Commerce, California, 90040

  • Altamed DVL El Monte

    El Monte, California, 91731

  • Altamed El Monte Clinic

    El Monte, California, 91731

  • Everett Family Practice

    Everett, Massachusetts, 02149

  • Altamed Garden Grove Harbor

    Garden Grove, California, 92840

  • Altamed Huntington Beach Clinic

    Huntington Beach, California, 92647

  • Altamed PACE Rugby

    Huntington Park, California, 90255

  • Brigham Primary Physicians at Faulkner

    Jamaica Plain, Massachusetts, 02130

  • Brookside Community Health Center

    Jamaica Plain, Massachusetts, 02130

  • Faulkner Community Physicians

    Jamaica Plain, Massachusetts, 02130

  • Southern Jamaica Plain Health Center

    Jamaica Plain, Massachusetts, 02130

  • The Children's Clinic Family Health Center at Cesar Chavez Elementary School

    Long Beach, California, 90802

  • The Children's Clinic Family Health Center at Hamilton Middle School

    Long Beach, California, 90805

  • The S. Mark Taper Foundation Children's Clinic Family Health Center

    Long Beach, California, 90806

  • The Children's Clinic at the Long Beach Multi-Service Center for the Homeless

    Long Beach, California, 90813

  • The Vasek Polak Children's Clinic Family Health Center

    Long Beach, California, 90813

  • Altamed PACE Grand Plaza

    Los Angeles, California, 90012

  • Altamed William Mead Homes

    Los Angeles, California, 90012

  • Altamed Commerce Clinic

    Los Angeles, California, 90022

  • Altamed DVL Commerce

    Los Angeles, California, 90022

  • Altamed PACE Pomona

    Los Angeles, California, 90022

  • Altamed Boyle Heights Clinic

    Los Angeles, California, 90023

  • Altamed Estrada Courts

    Los Angeles, California, 90023

  • Altamed Ramona Gardens

    Los Angeles, California, 90023

  • AltaMed 1st St Boyle Heights Clinic

    Los Angeles, California, 90033

  • Altamed Zonal Clinic

    Los Angeles, California, 90033

  • Altamed Montebello Clinic

    Montebello, California, 90640

  • Brigham and Women's Primary Care Associates of Newton Corner

    Newton, Massachusetts, 02458

  • Altamed El Modena Clinic

    Orange, California, 92869

  • Altamed Pico Clinic

    Pico Rivera, California, 90060

  • Altamed DVL Pico

    Pico Rivera, California, 90660

  • Mass General Revere HealthCare Center

    Revere, Massachusetts, 02151

  • Altamed Santa Ana Main

    Santa Ana, California, 92701

  • Altamed Clinic For Women

    Santa Ana, California, 92706

  • Altamed Santa Ana Broadway

    Santa Ana, California, 92707

  • Altamed Santa Ana Central

    Santa Ana, California, 92707

  • Mass General West Medical Group

    Waltham, Massachusetts, 02451

Other trials in United States

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 electronic health record (EHR) workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justifications triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions (AJ); and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparisons).

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 the clinics' Enterprise Data Warehouses which store copies of data recorded in the 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 laryngopharyngitis/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 SA arm, while clinicians randomized to the 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 condition will receive email updates about their antibiotic prescribing practices relative to other clinicians in their practice.

Being tested
Clinical Decision Support (CDS): Accountable Justifications, 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 (CDS): Accountable JustificationsBehavioural

    Also called AJ, Accountable Justification

    Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (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 groups in NCT01454947
Study groupRoleWhat they receive
SA, AJ, PCExperimentalParticipants are given all 3 interventions.
Receives: Behavioral: Clinical Decision Support (CDS): Accountable Justifications; Behavioral: Audit and Feedback: Peer Comparison; Behavioral: CDS Order Sets: Suggested Alternatives
SA, AJExperimentalParticipants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
Receives: Behavioral: Clinical Decision Support (CDS): Accountable Justifications; Behavioral: CDS Order Sets: Suggested Alternatives
SA, PCExperimentalParticipants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
Receives: Behavioral: Audit and Feedback: Peer Comparison; Behavioral: CDS Order Sets: Suggested Alternatives
AJ, PCExperimentalParticipants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
Receives: Behavioral: Clinical Decision Support (CDS): Accountable Justifications; Behavioral: Audit and Feedback: Peer Comparison
Peer Comparison (PC)ExperimentalParticipants 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 (SA)ExperimentalParticipants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Receives: Behavioral: CDS Order Sets: Suggested Alternatives
Accountable Justification (AJ)ExperimentalParticipants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Receives: Behavioral: Clinical Decision Support (CDS): Accountable Justifications
Education ControlNo interventionParticipants 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.

  1. Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses

    Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses:

    460 Acute nasopharyngitis (common cold)

    465 Acute laryngopharyngitis/acute upper respiratory infection

    466 Acute bronchitis

    490 Bronchitis not specified as acute or chronic

    487 Flu

    Measured: 18 months

Secondary outcomes (1)
  1. Encounters Closely Following the Index Encounter for Serious Diagnoses

    Within intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed, we will monitor return visit rates for the specified diagnoses and other acute respiratory infection diagnoses (ICD-9), including whooping cough (033.9), rheumatic fever (390-392) and pneumonia (481-487).

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionApr 2014
  4. Study completionSep 2014

Resources

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
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01454947
Sponsor's protocol ID
1RC4AG039115-01
Other IDs
1RC4AG039115-01
Acronym
BEARI
Status last verified
May 2024
First submitted
4 Aug 2011
Last updated
23 May 2024
Data monitoring committee
Yes

Publications

  • Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

    PubMed 26864410
  • Doctor JN, Goldstein NJ, Fox CR, Linder JA, Persell SD, Stewart EP, Knight TK, Meeker D. Clinician Job Satisfaction After Peer Comparison Feedback: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317379. doi: 10.1001/jamanetworkopen.2023.17379.

    PubMed 37289454
  • Gong CL, Zangwill KM, Hay JW, Meeker D, Doctor JN. Behavioral Economics Interventions to Improve Outpatient Antibiotic Prescribing for Acute Respiratory Infections: a Cost-Effectiveness Analysis. J Gen Intern Med. 2019 Jun;34(6):846-854. doi: 10.1007/s11606-018-4467-x. Epub 2018 May 8.

    PubMed 29740788
  • Gong CL, Hay JW, Meeker D, Doctor JN. Prescriber preferences for behavioural economics interventions to improve treatment of acute respiratory infections: a discrete choice experiment. BMJ Open. 2016 Sep 22;6(9):e012739. doi: 10.1136/bmjopen-2016-012739.

    PubMed 27660322
  • Persell SD, Friedberg MW, Meeker D, Linder JA, Fox CR, Goldstein NJ, Shah PD, Knight TK, Doctor JN. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics. BMC Infect Dis. 2013 Jun 27;13:290. doi: 10.1186/1471-2334-13-290.

    PubMed 23806017

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support (CDS): Accountable Justifications, 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 55 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?

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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 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?

Yes. Results are posted in the registry (first posted 20 Jun 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 Rate for Qualifying Acute Respiratory Infection Diagnoses (time frame: 18 months). 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 NCT01454947, which also lists 5 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 23 May 2024.

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