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临床试验/NCT00144040
NCT00144040已完成不适用

Improving Antibiotic Use in Acute Care Setting

US Department of Veterans Affairs9 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2004年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
9
主要终点
Proportion of all acute respiratory infection visits treated with antibiotics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Emergency room patient
  • •Selected VA or Non-VA patients
  • •Age 18 years or older
  • •Patient must have acute respiratory illness
  • •Patient must not have been seen in Emergency Department within 4 weeks

排除标准

  • •Patients less than 18 years of age
  • •Patient in Emergency Department for non-acute respiratory infection

研究组 & 干预措施

Arm 1

Other

干预措施: Physician & patient education on appropriate antibiotic use (Behavioral)

Arm 1

Other

干预措施: Rapid C-reactive protein testing to guide antibiotic treatment (Procedure)

结局指标

主要结局

Proportion of all acute respiratory infection visits treated with antibiotics

次要结局

  • Delayed antibiotic treatment of acute respiratory infections; Patient satisfaction

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (9)

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