Respiratory Infections Clinical Trial
Official title:
Improving Antibiotic Use in Acute Care Setting
Purpose The emergence and rapid rise in antibiotic resistance among common bacteria are adversely affecting the clinical course and health care costs of community-acquired infections. Because antibiotic resistance rates are strongly correlated with antibiotic use patterns, multiple organizations have declared reductions in unnecessary antibiotic use to be critical components of efforts to combat antibiotic resistance. Among humans, the vast majority of unnecessary antibiotic prescriptions are used to treat acute respiratory tract infections (ARIs) that have a viral etiology. Although the rate of antibiotic prescribing for ARIs by office-based physicians in the US has decreased about 16% from its peak in 1997, the rate of antibiotic prescribing in acute care settings (eg, emergency departments and urgent care centers), which account for 1 in 5 ambulatory antibiotic prescriptions in the US, has shown only a modest decline (6%) during this period. Translation of lessons from intervention studies in office-based practices is needed to improve antibiotic use in acute care settings.
Objectives:
Specific Aim 1: To evaluate the impact of a multidimensional (patient, system, clinician)
intervention on appropriate antibiotic use for adults with acute respiratory tract
infections-- identifying factors that influence successful translation across VA hospital
and non-VA hospital acute care. Specific Aim 2: To evaluate the impact of a rapid diagnostic
test for c-reactive protein on antibiotic use for adults with acute cough illness when added
to a multidimensional intervention.
Methods:
We propose to conduct a randomized controlled trial of a quality improvement program
consisting of physician education (educational seminar, practice guidelines, performance
feedback, and decision support tools) and patient education (waiting room print and
audiovisual materials) in 8 VA hospital and 8 non-VA hospital emergency departments. Non VA
study sites will be identified from an existing research network of hospital emergency
departments--EDNet. VA hospital sites will be selected among academically affiliated hub
facilities. Phase one will involve a hospital-level randomized trial of a multidimensional
intervention to translate existing evidence based guidelines for antibiotic use in ARIs vs.
usual care. Simultaneously, we will validate a new CRP-based diagnostic algorithm and
incorporate it into the evidence based guidelines for antibiotic use in ARIs. Phase two will
involve a second hospital-level randomized trial of the new antibiotic use guidelines that
incorporate the CRP-based diagnostic algorithm vs. the original guidelines. Specific
endpoints include the overall success of the intervention in each phase in terms of reducing
antibiotic prescribing for ARIs, improving patient outcomes and reducing resource
utilization. In addition we will examin the impact of VA and non-VA organizational factors
on the successful translation of various components of the intervention in both phases. Data
will be collected using existing administrative data as well as on-site enrollment of
subjects in prospective follow-up studies.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
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