Refining Information Technology Support for Genetics in Medicine
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Efficiency of Obtaining Updated Genetic Variant Information
研究概览
简要总结
The clinical use of genetic testing is expanding and, as a result, the number of variants identified in patients is growing. Knowledge of the clinical impact of these variants improves over time. However, the combination of more testing and the rapid evolution of genetic knowledge make it impossible for clinicians to fully account for the latest implications of their patients' genetic profiles as patient care decisions are made. This proposed study plans to enhance and evaluate IT infrastructure developed to provide timely genetic variant updates and patient search functionality to clinicians to assist in optimizing patient care.
详细描述
A. Specific Aims
Aim 1: To assess the usability of successive versions of our EHR genetic display screens and variant-based patient search functionality.
Formal usability studies will be conducted with each new release of the GeneInsight Clinic (GIC) application in order to maximize its effectiveness and efficiency, and user satisfaction. Results from these studies will be used along with functional and technical requirements in designing enhancements to each successive version of the software.
Hypothesis: The usability of GeneInsight Clinic and the application's effectiveness, efficiency, and user satisfaction will improve with each successive version.
Aim 2. To assess the decision-making process associated with issuing alerts relating to new knowledge on germline variants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study subjects selected from Partners HealthCare and non-Partners study sites include:
- •treating clinicians
- •geneticists
- •genetic counselors
- •pathologists
排除标准
- 未提供
结局指标
主要结局
Efficiency of Obtaining Updated Genetic Variant Information
时间窗: Continuous across 21 months
Phone and email logging procedures will be implemented before study onset to establish a solid baseline. Laboratory staff will log each time they receive a phone call or email requesting updated information on a genetic variant. These logs will be maintained throughout the study period even once the GIC tool becomes available. System auditing processes will capture data on when genetic variants are updated, when alerts are sent, and clinician accesses to online screens. Centralized system data will be evaluated to track usage of the GIC patient search functions, using a flagging approach.
次要结局
- Perception of Impact of Variant Update Significance Level Alerting on Clinical Care(Continuous Across 21 months)
- Perception of Impact of Variant Update Significance Level Alerting on Clinician Workload(Continuous Across 21 months)
- Perception of Impact of Variant Update Significance Level Alerting on Clinician Satisfaction(Continuous Across 21 months)
研究者
David W. Bates, MD, MSc
Chief, Division of General Internal Medicine
Brigham and Women's Hospital