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临床试验/NCT01099943
NCT01099943已完成不适用

Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change in antibiotics prescribing behavior

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinic practices within Denver Health's Webb Center for Primary Care,
  • Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic,
  • Clinic practices within the High Plains Network, and
  • Clinical practices within the Wilmington Health Associates System
  • The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking:
  • Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing,
  • 30-day events (hospitalizations,
  • Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study.

排除标准

  • Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest.

结局指标

主要结局

Change in antibiotics prescribing behavior

时间窗: December 2009 through August 2011

次要结局

  • The number and type of changes made to workflow processes when setting up or changing systems to change prescribing methods(December 2009 through August 2011)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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