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临床试验/NCT01956773
NCT01956773已完成不适用

Family Health History in Diverse Care Settings

Duke University10 个研究点 分布在 1 个国家目标入组 2,620 人开始时间: 2014年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,620
试验地点
10
主要终点
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year

研究概览

简要总结

The outcome of this research will be a demonstration that family health history (FHH) risk data can be used efficiently to deliver more effective healthcare in geographically and ethnically diverse clinical care environments. Although FHH is a standard component of the medical interview its widespread adoption is hindered by three major barriers: (1) a dearth of standard collection methods; (2) the absence of health care provider access to complete FHH information; and (3) the need for clinical guidance for the interpretation and use of FHH. In addition, the time constraints of the busy provider and poor integration of FHH with paper medical records or electronic medical records (EMR) impede its widespread use. The investigators hypothesize that patient-driven and electronic collection of FHH for risk stratification will promote more informed decision-making by patients and providers, and improves adherence to risk-stratified preventive care guidelines. The study team will use an implementation sciences approach to integrate an innovative FHH system that collects FHH from patients. Intermountain Healthcare will provide the information technology expertise with EMR design to develop an innovative solution to a storage model standard for FHH data as well as a centralized standards-compliant open clinical decision support (OpenCDS) rule development architecture to analyze FHH and to generate evidence-based, individualized, disease risk, preventive care recommendations for both patients and providers.

详细描述

Five health care delivery organizations will participate in this demonstration project: Duke University, the Medical College of Wisconsin, the Air Force, Essentia Health, and the University of North Texas Health Science Center. The study will take place in 'real world' clinical, socio-cultural, and demographically diverse (rural, underserved, academic, family medicine) care clinics (n=34) in 5 states (CA, MN, NC, WI, TX) that include genomic medicine 'early adopter' and 'naïve' sites, as well as those that are EMR-enabled and others that are not. The study team will recruit a minimum of 7000 English or Spanish speaking adults over a 3-year period and will capture process metrics and outcomes that are measured in the course of usual care. The goals are: 1) To optimize the collection of patient entered FHH in diverse clinical environments for coronary heart disease, thrombosis, and selected cancers, 2) to export FHH data to an OpenCDS platform and return CDS results to providers and patients (and to EMRs where relevant) and to explore the integration of genetic risk and FHH data at selected sites, 3) to assess the clinical and personal utility of FHH using a pragmatic observational study design to assess reach, adoption, integrity, exposure, and sustainability, and to capture, analyze, and report effectiveness outcomes at each stakeholder level: patient, provider, and clinic/system, and 4) to take a leadership role in the dissemination of guidelines for FHH intervention across in diverse practice settings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Adults 18 years of age
  • Scheduled for a well visit appointment in selected clinics
  • English and Spanish speaking
  • Able to provide informed consent

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year

时间窗: Baseline, 3 and 12 months

How many patients identified as meeting criteria for genetic counseling, how many providers ordered genetic counseling, and how many patients adhere to the provider recommendation at 1 year.

次要结局

  • Number of Participants Reporting Satisfaction When Using the MeTree Tool(3 months)
  • Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load(3 months)
  • Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow(1 year)
  • Number of Participants Reporting Comfort When Using the MeTree Tool(3 months)
  • Number of Participants Reporting Anxiety When Using the MeTree Tool(3 months)
  • Number of Participants Reporting Preparedness When Using the MeTree Tool(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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