An interventional study of Clinical Decision Support (CDS): Accountable Justifications and Audit and Feedback: Peer Comparison in Acute Respiratory Infections (ARIs), sponsored by University of Southern California. Completed at 55 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 248 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are given all 3 interventions.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications · Behavioral: Audit and Feedback: Peer Comparison · Behavioral: CDS Order Sets: Suggested Alternatives
Participants receive the Suggested Alternatives and Accountable Justification interventions, but not the Peer Comparison intervention.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications · Behavioral: CDS Order Sets: Suggested Alternatives
Participants receive the Suggested Alternative and Peer Comparison interventions, but not the Accountable Justification intervention.
Behavioral: Audit and Feedback: Peer Comparison · Behavioral: CDS Order Sets: Suggested Alternatives
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternative intervention.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications · Behavioral: Audit and Feedback: Peer Comparison
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
Behavioral: Audit and Feedback: Peer Comparison
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
Behavioral: CDS Order Sets: Suggested Alternatives
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Behavioral: Clinical Decision Support (CDS): Accountable Justifications
Participants do not receive any of the 3 interventions.
Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
Also known as: AJ, Accountable Justification
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
Also known as: PC, Peer Comparison
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
Also known as: SA, Suggested Alternatives
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
Time frame: 18 months
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).
Time frame: 18 months
| Milestone | Education Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | SA, AJ | SA, PC | AJ, PC | SA, AJ, PC |
|---|---|---|---|---|---|---|---|---|
| Started | 27 | 42 | 35 | 20 | 34 | 35 | 27 | 28 |
| Completed | 24 | 38 | 32 | 19 | 33 | 32 | 26 | 23 |
| Not completed | 3 | 4 | 3 | 1 | 1 | 3 | 1 | 5 |
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
| proportion of visits | Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | Suggested Alternatives + Accountable Justification | Suggested Alternatives + Peer Comparison | Accountable Justification + Peer Comparison | SA+AJ+PC |
|---|---|---|---|---|---|---|---|---|
| Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses | 0.20 (0.10 to 0.31) | 0.19 (0.06 to 0.66) | 0.08 (0.03 to 0.23) | 0.09 (0.03 to 0.31) | 0.07 (0.02 to 0.24) | 0.01 (0.00 to 0.08) | 0.03 (0.00 to 0.18) | 0.03 (0.00 to 0.22) |
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).
| Qualifying encounters | Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | Suggested Alternatives + Accountable Justification | Suggested Alternatives + Peer Comparison | Accountable Justification + Peer Comparison | SA+AJ+PC |
|---|---|---|---|---|---|---|---|---|
| Encounters Closely Following the Index Encounter for Serious Diagnoses | 14 | 16 | 16 | 13 | 22 | 23 | 48 | 15 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Control | — | 0/3,245 (0%) | 14/3,245 (0.4%) |
| Suggested Alternatives (SA) | — | 0/4,579 (0%) | 16/4,579 (0.3%) |
| Accountable Justification (AJ) | — | 0/4,622 (0%) | 16/4,622 (0.3%) |
| Peer Comparison (PC) | — | 0/3,781 (0%) | 13/3,781 (0.3%) |
| SA, AJ | — | 0/5,717 (0%) | 22/5,717 (0.4%) |
| SA, PC | — | 0/5,993 (0%) | 23/5,993 (0.4%) |
| AJ, PC | — | 0/3,398 (0%) | 48/3,398 (1.4%) |
| SA, AJ, PC | — | 0/4,164 (0%) | 15/4,164 (0.4%) |
| Event | Education Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | SA, AJ | SA, PC | AJ, PC | SA, AJ, PC |
|---|---|---|---|---|---|---|---|---|
| return visits for bacterial infections occurring within 30 days of study qualifying ARI visit whereInfections and infestations | 14/3245 | 16/4579 | 16/4622 | 13/3781 | 22/5717 | 23/5993 | 48/3398 | 15/4164 |
Enrolled Clinicians
| Age, Continuous(years) | Education Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | SA, AJ | SA, PC | AJ, PC | SA, AJ, PC | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 47 ± 12 | 49 ± 10 | 49 ± 9 | 46 ± 9 | 48 ± 9 | 51 ± 11 | 48 ± 10 | 46 ± 9 | 48 ± 10 |
| Sex: Female, Male(Participants) | Education Control | Suggested Alternatives (SA) | Accountable Justification (AJ) | Peer Comparison (PC) | SA, AJ | SA, PC | AJ, PC | SA, AJ, PC | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 13 | 30 | 22 | 12 | 24 | 25 | 15 | 16 | 157 |
| Male | 14 | 12 | 13 | 8 | 10 | 10 | 12 | 12 | 91 |
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