此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study) (BEARI)

2017年3月31日 更新者:Jason Doctor、University of Southern California

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

28

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60611-2923
        • Northwestern Medical Faculty Foundation General Internal Medicine Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:萨、阿杰
参与者会收到建议的替代方案和负责任的理由干预措施,但不会收到同行比较干预措施。
由 EHR 工作流程触发的订单集,包含专门的指南一致选择(SA,代表建议的替代方案)。
其他名称:
  • SA
  • 建议的替代方案
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
其他名称:
  • 负责任的理由
  • 阿杰
实验性的:SA, AJ, PC

Participants are given all 3 interventions:

Suggested Alternatives, Accountable Justification, and Peer Comparison.

绩效反馈,将提供商自身的绩效与同行的绩效进行基准比较(PC,用于同行比较)。
其他名称:
  • 个人电脑
  • 同行比较
由 EHR 工作流程触发的订单集,包含专门的指南一致选择(SA,代表建议的替代方案)。
其他名称:
  • SA
  • 建议的替代方案
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
其他名称:
  • 负责任的理由
  • 阿杰
实验性的:SA, PC
Participants receive the Suggested Alternatives and Peer Comparison interventions, but not the Accountable Justification intervention.
绩效反馈,将提供商自身的绩效与同行的绩效进行基准比较(PC,用于同行比较)。
其他名称:
  • 个人电脑
  • 同行比较
由 EHR 工作流程触发的订单集,包含专门的指南一致选择(SA,代表建议的替代方案)。
其他名称:
  • SA
  • 建议的替代方案
实验性的:AJ, PC
Participants receive the Accountable Justification and Peer Comparison interventions, but not the Suggested Alternatives intervention.
绩效反馈,将提供商自身的绩效与同行的绩效进行基准比较(PC,用于同行比较)。
其他名称:
  • 个人电脑
  • 同行比较
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
其他名称:
  • 负责任的理由
  • 阿杰
实验性的:Peer Comparison
Participants receive the Peer Comparison intervention, but do not receive the Suggested Alternatives or Accountable Justification interventions.
绩效反馈,将提供商自身的绩效与同行的绩效进行基准比较(PC,用于同行比较)。
其他名称:
  • 个人电脑
  • 同行比较
实验性的:Suggested Alternatives
Participants receive the Suggested Alternatives intervention, but not the Accountable Justification or Peer Comparison interventions.
由 EHR 工作流程触发的订单集,包含专门的指南一致选择(SA,代表建议的替代方案)。
其他名称:
  • SA
  • 建议的替代方案
实验性的:Accountable Justification
Participants receive the Accountable Justification intervention, but do not receive the Suggested Alternatives or Peer Comparison interventions.
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
其他名称:
  • 负责任的理由
  • 阿杰
无干预:Control
Participants do not receive any of the 3 interventions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses
大体时间:2 years

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

次要结果测量

结果测量
措施说明
大体时间
Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses
大体时间:2 years
We will monitor overall prescribing for the specified diagnoses and other Acute Respiratory Infection diagnoses, including cough/fever and pneumonia.
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stephen Persell, MD、Northwestern University
  • 研究主任:Jason N Doctor, PhD、University of Southern California

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2011年8月4日

首先提交符合 QC 标准的

2011年10月18日

首次发布 (估计)

2011年10月19日

研究记录更新

最后更新发布 (实际的)

2017年4月4日

上次提交的符合 QC 标准的更新

2017年3月31日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1RC4AG039115-01-2
  • 1RC4AG039115-01 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅