- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01454960
Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study) (BEARI)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611-2923
- Northwestern Medical Faculty Foundation General Internal Medicine Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: SA, A.J
I partecipanti ricevono gli interventi di Alternative suggerite e Giustificazione responsabile, ma non l'intervento di Confronto tra pari.
|
Set di ordini attivati dal flusso di lavoro EHR contenenti esclusivamente scelte concordanti con le linee guida (SA, per alternative suggerite).
Altri nomi:
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Altri nomi:
|
|
Sperimentale: SA, AJ, PC
Participants are given all 3 interventions: Suggested Alternatives, Accountable Justification, and Peer Comparison. |
Feedback sulle prestazioni che confronta le prestazioni dei fornitori con quelle dei loro colleghi (PC, per Peer Comparison).
Altri nomi:
Set di ordini attivati dal flusso di lavoro EHR contenenti esclusivamente scelte concordanti con le linee guida (SA, per alternative suggerite).
Altri nomi:
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Altri nomi:
|
|
Sperimentale: SA, PC
Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention.
|
Feedback sulle prestazioni che confronta le prestazioni dei fornitori con quelle dei loro colleghi (PC, per Peer Comparison).
Altri nomi:
Set di ordini attivati dal flusso di lavoro EHR contenenti esclusivamente scelte concordanti con le linee guida (SA, per alternative suggerite).
Altri nomi:
|
|
Sperimentale: AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention.
|
Feedback sulle prestazioni che confronta le prestazioni dei fornitori con quelle dei loro colleghi (PC, per Peer Comparison).
Altri nomi:
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Altri nomi:
|
|
Sperimentale: Peer Comparison
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
|
Feedback sulle prestazioni che confronta le prestazioni dei fornitori con quelle dei loro colleghi (PC, per Peer Comparison).
Altri nomi:
|
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Sperimentale: Suggested Alternatives
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
|
Set di ordini attivati dal flusso di lavoro EHR contenenti esclusivamente scelte concordanti con le linee guida (SA, per alternative suggerite).
Altri nomi:
|
|
Sperimentale: Accountable Justification
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
|
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
Altri nomi:
|
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Nessun intervento: Control
Participants do not receive any of the 3 interventions.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
Lasso di tempo: 2 years
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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 |
2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
Lasso di tempo: 2 years
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We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.
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2 years
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Stephen Persell, MD, Northwestern University
- Direttore dello studio: Jason N Doctor, PhD, University of Southern California
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1RC4AG039115-01-2
- 1RC4AG039115-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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