Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking (EHR Project)
2020年5月11日 更新者：University of Wisconsin, Madison
Smoking is the leading preventable cause of cancer mortality in the US.
Despite its profound health and economic costs, smoking treatment is infrequently provided in healthcare settings, and when provided, it is not sufficiently effective.
To address this, this project will develop and evaluate more efficient electronic health record (EHR) methods to identify smokers and engage them in evidence-based treatment.
研究概览
详细说明
Specifically, this Project will develop and test new EHR enhancements and associated healthcare practices that are designed to efficiently identify smokers and recruit them into a chronic care treatment for smoking (which will be developed and evaluated in Projects 2-4).
The EHR enhancements will include: 1) smoker identification and documentation aids, 2) a "Smoker Registry" (which stores relevant data on smokers and facilitates tracking their smoking status over time), 3) a 1-click system to refer smokers to the chronic care treatment for smoking, 4) a closed-loop function to provide EHR feedback to clinicians on the outcomes of their referrals, and 5) communications resources to inform smokers of treatment options and to increase their recruitment into treatment.
The effects of the EHR-based enhancements and the chronic care smoking treatment will be evaluated with a multiple baseline design involving 18 primary care clinics in three healthcare systems in Wisconsin; all participants for affiliated clinical research Projects will be recruited from these clinics.
This highly innovative research will evaluate the impact of an integrated set of EHR enhancements-coupled with a chronic care approach to smoking treatment-on smoker identification, and smoking treatment referral and engagement.
In addition, this research will explore factors that influence the use of EHR-based enhancements in clinics.
In sum, this research will develop a set of EHR-based health system enhancements that increase both the adoption of chronic care treatment by healthcare systems and smokers' engagement in that treatment.
研究类型
观察性的
注册 (实际的)
28095
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
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Wisconsin
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Madison、Wisconsin、美国、53711
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
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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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This is a multiple baseline design with the unit of analysis as the clinic.
20-28 clinics will be recruited.
描述
Inclusion Criteria:
The clinics participating in the MBD experiment will be selected based on the following criteria:
- Size: clinics will be fairly large, including at least 4-6 clinicians, to ensure adequate recruitment for clinical trials connected with thye EHR recruitment.
- Location: clinics will be concentrated in Southcentral and Southeastern Wisconsin so that case managers from UW-CTRI Madison and Milwaukee research sites can provide services at multiple clinics.
- Diversity: clinics from each of the two health systems will include both urban and rural locations, and at least one high- and one low-SES clinic (based on rates of Medicaid and uninsured patients).
- Independence: clinics will not share staff or be physically adjacent to one another to combat bleeding of interventions across clinics (see 87 for the independence requirement for MBD).
- All clinics will routinely collect the data that will serve as dependent variables in the MBD design (this will be universal among the three health system clinics).
Exclusion Criteria:
- Any clinic not meeting the above inclusion criteria
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
队列和干预
团体/队列 |
干预/治疗 |
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EHR Enhanced Clinic Referral
A set of standard EHR modifications will be implemented in 18 clinics as part of the MBD (multiple baseline design) experiment.The key new EHR functions that will be implemented and tested are: 1) a modified "screen for smoking sta-tus" to enhance the identification and documentation of all smokers visiting targeted primary care clinics; 2) a "Smoker Registry" to track smokers, document their receipt of treatment services, and organize direct-to-consumer communications; 3) a 1-click referral system to evidence-based smoking treat-ment with UW-CTRI case managers; 4) a closed-loop feedback feature to communicate to the clinician the fate of a referral, documenting receipt of the referral and treatment engagement; and 5) EHR-based communication options to inform smokers of treatment resources
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The clinics assigned to the experimental condition will have EHR enhancements introduced.
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Standard care (control) clinics
10 control clinics will also be inducted into the study.
These clinics will use existing EHR resources to identify smokers (e.g., the expanded vital signs) and to document their smoking status, and then use the standard paper fax-to-quit methods to refer patients to the Wisconsin Tobacco Quit Line
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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 |
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Treatment engagement rate among smokers at a clinic
大体时间：12 months
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Percentage of those smokers identified in a clinic who engage in smoking related treatment
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12 months
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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：Michael C Fiore, MD、University of Wisconsin, Madison
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 (实际的)
2015年2月1日
初级完成 (实际的)
2018年8月1日
研究完成 (实际的)
2018年8月1日
研究注册日期
首次提交
2015年2月3日
首先提交符合 QC 标准的
2015年2月5日
首次发布 (估计)
2015年2月6日
研究记录更新
最后更新发布 (实际的)
2020年5月13日
上次提交的符合 QC 标准的更新
2020年5月11日
最后验证
2020年5月1日
更多信息
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.