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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01454960
Other study ID # 1RC4AG039115-01-2
Secondary ID 1RC4AG039115-01
Status Completed
Phase N/A
First received August 4, 2011
Last updated March 31, 2017
Start date July 2011
Est. completion date September 2014

Study information

Verified date March 2017
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 2014
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Clinical Decision Support: 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 Comparison
Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
CDS Order Sets: Suggested Alternatives
Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).

Locations

Country Name City State
United States Northwestern Medical Faculty Foundation General Internal Medicine Clinic Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
2 years
Secondary 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. 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01767064 - Nudging Guideline-concordant Antibiotic Prescribing Using Public Commitments N/A
Completed NCT01454947 - Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Main Study) N/A