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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC4AG039115-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SA, AJ, PC | Experimental | Participants are given all 3 interventions. |
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| SA, AJ | Experimental | Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. |
|
| SA, PC | Experimental | Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. |
|
| AJ, PC | Experimental | Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. |
|
| Peer Comparison (PC) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support (CDS): Accountable Justifications | Behavioral | Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason N Doctor, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altamed Anaheim Lincoln | Anaheim | California | 92801 | United States | ||
| Altamed Anaheim West |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26864410 | Background | 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. | |
| 37289454 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Education Control | Participants do not receive any of the 3 interventions. |
| FG001 | Suggested Alternatives (SA) | Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. |
|
| Suggested Alternatives (SA) | Experimental | Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. |
|
| Accountable Justification (AJ) | Experimental | Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. |
|
| Education Control | No Intervention | Participants do not receive any of the 3 interventions. |
|
| Audit and Feedback: Peer Comparison | Behavioral | Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison). |
|
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| CDS Order Sets: Suggested Alternatives | Behavioral | Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives). |
|
|
| Anaheim |
| California |
| 92801 |
| United States |
| Altamed Bell Clinic | Bell | California | 90201 | United States |
| Altamed Mobile Unit Primary Care | Commerce | California | 90040 | United States |
| Altamed DVL El Monte | El Monte | California | 91731 | United States |
| Altamed El Monte Clinic | El Monte | California | 91731 | United States |
| Altamed Garden Grove Harbor | Garden Grove | California | 92840 | United States |
| Altamed Huntington Beach Clinic | Huntington Beach | California | 92647 | United States |
| Altamed PACE Rugby | Huntington Park | California | 90255 | United States |
| The Children's Clinic Family Health Center at Cesar Chavez Elementary School | Long Beach | California | 90802 | United States |
| The Children's Clinic Family Health Center at Hamilton Middle School | Long Beach | California | 90805 | United States |
| The S. Mark Taper Foundation Children's Clinic Family Health Center | Long Beach | California | 90806 | United States |
| The Children's Clinic at the Long Beach Multi-Service Center for the Homeless | Long Beach | California | 90813 | United States |
| The Vasek Polak Children's Clinic Family Health Center | Long Beach | California | 90813 | United States |
| Altamed PACE Grand Plaza | Los Angeles | California | 90012 | United States |
| Altamed William Mead Homes | Los Angeles | California | 90012 | United States |
| Altamed Commerce Clinic | Los Angeles | California | 90022 | United States |
| Altamed DVL Commerce | Los Angeles | California | 90022 | United States |
| Altamed PACE Pomona | Los Angeles | California | 90022 | United States |
| Altamed Boyle Heights Clinic | Los Angeles | California | 90023 | United States |
| Altamed Estrada Courts | Los Angeles | California | 90023 | United States |
| Altamed Ramona Gardens | Los Angeles | California | 90023 | United States |
| AltaMed 1st St Boyle Heights Clinic | Los Angeles | California | 90033 | United States |
| Altamed Zonal Clinic | Los Angeles | California | 90033 | United States |
| Altamed Montebello Clinic | Montebello | California | 90640 | United States |
| Altamed El Modena Clinic | Orange | California | 92869 | United States |
| Altamed Pico Clinic | Pico Rivera | California | 90060 | United States |
| Altamed DVL Pico | Pico Rivera | California | 90660 | United States |
| Altamed Santa Ana Main | Santa Ana | California | 92701 | United States |
| Altamed Clinic For Women | Santa Ana | California | 92706 | United States |
| Altamed Santa Ana Broadway | Santa Ana | California | 92707 | United States |
| Altamed Santa Ana Central | Santa Ana | California | 92707 | United States |
| Brigham and Women's Primary Care Associates at Foxborough | Boston | Massachusetts | 02035 | United States |
| MGH Downtown | Boston | Massachusetts | 02108 | United States |
| Mass General Medial Group | Boston | Massachusetts | 02114 | United States |
| MGH Beacon Hill | Boston | Massachusetts | 02114 | United States |
| MGH Senior Health | Boston | Massachusetts | 02114 | United States |
| Women's Health Associates | Boston | Massachusetts | 02114 | United States |
| Brigham Circle Medical Associates | Boston | Massachusetts | 02115 | United States |
| Brigham Internal Medicine Associates | Boston | Massachusetts | 02115 | United States |
| Spanish Clinic | Boston | Massachusetts | 02115 | United States |
| MGH Back Bay | Boston | Massachusetts | 02228 | United States |
| Brigham and Women's Primary Care Associates of Brookline | Brookline | Massachusetts | 02446 | United States |
| MGH Charlestown HealthCare Center | Charlestown | Massachusetts | 02129 | United States |
| MGH Chelsea HealthCare Center | Chelsea | Massachusetts | 02150 | United States |
| Brigham and Women's Physician Group | Chestnut Hill | Massachusetts | 02467 | United States |
| Gretchen and Edward Fish Center for Women's Health | Chestnut Hill | Massachusetts | 02467 | United States |
| Everett Family Practice | Everett | Massachusetts | 02149 | United States |
| Brigham Primary Physicians at Faulkner | Jamaica Plain | Massachusetts | 02130 | United States |
| Brookside Community Health Center | Jamaica Plain | Massachusetts | 02130 | United States |
| Faulkner Community Physicians | Jamaica Plain | Massachusetts | 02130 | United States |
| Southern Jamaica Plain Health Center | Jamaica Plain | Massachusetts | 02130 | United States |
| Brigham and Women's Primary Care Associates of Newton Corner | Newton | Massachusetts | 02458 | United States |
| Mass General Revere HealthCare Center | Revere | Massachusetts | 02151 | United States |
| Mass General West Medical Group | Waltham | Massachusetts | 02451 | United States |
| 29740788 | Derived | 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. |
| 27660322 | Derived | 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. |
| 23806017 | Derived | 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. |
| FG002 | Accountable Justification (AJ) | Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. |
| FG003 | Peer Comparison (PC) | Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. |
| FG004 | SA, AJ | Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. |
| FG005 | SA, PC | Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. |
| FG006 | AJ, PC | Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. |
| FG007 | SA, AJ, PC | Participants are given all 3 interventions. |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled Clinicians
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| ID | Title | Description |
|---|---|---|
| BG000 | Education Control | Participants do not receive any of the 3 interventions. |
| BG001 | Suggested Alternatives (SA) | Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. |
| BG002 | Accountable Justification (AJ) | Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. |
| BG003 | Peer Comparison (PC) | Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. |
| BG004 | SA, AJ | Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. |
| BG005 | SA, PC | Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. |
| BG006 | AJ, PC | Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. |
| BG007 | SA, AJ, PC | Participants are given all 3 interventions. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza. | Posted | Number | 95% Confidence Interval | proportion of visits | 18 months | Qualifying ARI visits | Qualifying ARI visits |
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| Secondary | 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). | Overall number of units analyzed is the number of intervention-qualifying acute respiratory infections (ARI) encounters where no antibiotic was prescribed. Intervention-qualifying ARI encounters include all ARI visits eligible for the suggested alternatives and accountable justification interventions (not limited to the antibiotic-inappropriate ARI diagnoses that define the primary outcome). | Posted | Count of Units | Qualifying encounters | 18 months | Qualifying encounters | Qualifying encounters |
|
For antibiotic-inappropriate visits in which no antibiotic was prescribed, we assessed return visits within 30 days for the presence of complications potentially attributable to untreated bacterial infections
Intervention-qualifying acute respiratory infections (ARI) encounters include all ARI visits eligible for the suggested alternatives and accountable justification interventions (not limited to the antibiotic-inappropriate ARI diagnoses that define the primary outcome). A Diagnosis of Concern (DoC) was based on International Classification of Diseases version 9 (ICD9) codes of concern at revisit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education Control | Participants do not receive any of the 3 interventions. | 0 | 3,245 | 14 | 3,245 | ||
| EG001 | Suggested Alternatives (SA) | Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions. | 0 | 4,579 | 16 | 4,579 | ||
| EG002 | Accountable Justification (AJ) | Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions. | 0 | 4,622 | 16 | 4,622 | ||
| EG003 | Peer Comparison (PC) | Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. | 0 | 3,781 | 13 | 3,781 | ||
| EG004 | SA, AJ | Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention. | 0 | 5,717 | 22 | 5,717 | ||
| EG005 | SA, PC | Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention. | 0 | 5,993 | 23 | 5,993 | ||
| EG006 | AJ, PC | Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention. | 0 | 3,398 | 48 | 3,398 | ||
| EG007 | SA, AJ, PC | Participants are given all 3 interventions. | 0 | 4,164 | 15 | 4,164 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| return visits for bacterial infections occurring within 30 days of study qualifying ARI visit where | Infections and infestations | ICD9 | Systematic Assessment | For antibiotic-inappropriate visits in which no antibiotic was prescribed, we assessed return visits within 30 days for the presence of complications potentially attributable to untreated bacterial infections |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason N. Doctor | University of Southern California | 213.821.8142 | jdoctor@usc.edu |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Qualifying ARI visits |
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| OG003 | Peer Comparison (PC) | Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions. |
| OG004 | Suggested Alternatives + Accountable Justification | Participants receive the Suggested Alternatives and Accountable Justification interventions, but do not receive the Peer Comparison intervention |
| OG005 | Suggested Alternatives + Peer Comparison | Participants receive the Suggested Alternatives and Peer Comparison interventions, but do not receive the Accountable Justification intervention |
| OG006 | Accountable Justification + Peer Comparison | Participants receive the Accountable Justification and Peer Comparison interventions, but do not receive the Suggested Alternatives intervention |
| OG007 | SA+AJ+PC | Participants receive all three interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison interventions |
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