Infectious Diseases Clinical Trial
Official title:
Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians
Hypotheses and Specific Aims:
The continued emergence of antibiotic-resistance in the outpatient setting underlines the
need to responsibly manage antimicrobial prescribing. It is in this context that we seek to
test an effective strategy for reducing the inappropriate use of antibiotics in primary care
office practices. Our overall objective is to identify an effective and efficient strategy
for decreasing the contribution of primary care clinicians to the emergence of
antimicrobial-resistant bacteria in the community and to disseminate widely those strategies
found to be effective and sustainable.
We hypothesize that implementation of a clinician decision support system, with an active
education component, will reduce the inappropriate use of antibiotics in primary care office
practices. Our hypothesis is based on the premise that most inappropriate prescribing is the
result of multiple factors that include difficulty in distinguishing a benign, self-limited
viral infection from a more serious bacterial infection; overdiagnosis of a bacterial
infection in cases where there is clinical uncertainty as to the true nature of the illness;
and constraints on the time available for clinicians to explain to patients the nature of
the illness and the reasons an antibiotic is not indicated.
The focus of this proposal will be to compare the impact of clinical decision support and
active education to no intervention for enhancing the appropriate use of antimicrobials for
common outpatient infections. In this randomized control trial, primary care providers
participating in the intervention arm will receive active education coupled with the
implementation of a clinical decision support tool, while providers in the control arm will
have no intervention. At the end of the study, providers in the control arm will receive a
thorough analysis of their antibiotic prescribing patterns and suggested opportunities for
improvement, as well as access to the intervention tools once the study has ended.
Our interdisciplinary team will integrate novel methods in implementation science with
clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary
care, information technology, performance improvement, health services research, and
biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary
care setting by demonstrating two results of our intervention strategy:
1. Reduced use of antibiotics to treat conditions for which those drugs are known not to
be effective
2. Decreased prescribing of broad-spectrum antibiotics to treat common bacterial
infections.
The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient
infection will be compared with active education and clinical decision support versus no
intervention. The study will be able to measure the value of clinical decision support with
active education that will inform future efforts in disseminating outpatient antibiotic
stewardship interventions.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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