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临床试验/NCT02530216
NCT02530216已完成不适用

Automated Evaluation of Gastrointestinal Symptoms (AEGIS): A Pragmatic Clinical Trial Evaluating the Impact of AEGIS on Clinical Outcomes

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2017年4月10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
610
试验地点
2
主要终点
Prevalence of documented alarm symptoms

研究概览

简要总结

Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient-provider interaction. Electronic health records (EHRs) have the potential to improve outcomes and quality of care in this pressured environment, and are endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support value-based healthcare. However, EHR systems were principally designed to support the transactional needs of administrators and billers, less so to nurture the relationship between patients and their providers. The purpose of this research is to identify ways to use EHRs to support clinical gastroenterologists and their patients while meeting the meaningful use requirements of the HITECH Act.

To improve clinic visit efficiency and meet criteria for meaningful use, investigators developed a patient-provider portal (P3) that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a library of over 300 symptom attributes measuring the timing, severity, frequency, location, quality, and character of their GI symptoms, along with relevant comorbidities, family history, and alarm features. The system then automatically "translates" the patient report into a full narrative HPI available for use by GI providers in an EHR.

In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus physician-documented HPIs, investigators found that blinded physician reviewers perceived that AEGIS HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete and useful compared to HPIs written by physicians during usual care in academic GI clinics. In the current study, investigators aim to evaluate computer-generated HPIs prospectively on a wider scale in diverse academic and community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention that ties patient HPIs to an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Presenting to the gastrointestinal clinic for evaluation.
  • Able to read and write English.
  • Has basic computing skills.

排除标准

  • Having been seen and evaluated in the gastrointestinal clinic within the last 8 months.

研究组 & 干预措施

Usual care

No Intervention

Individuals in this arm will undergo usual care with their physician.

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Experimental

Individuals in the AEGIS arm will be invited to use AEGIS/My GI Health prior to their clinic visit. For those who complete AEGIS/My GI Health, their physician will have access to their AEGIS symptom report (includes a GI symptom heat map and GI history) and tailored education prescription.

干预措施: AEGIS (Automated Evaluation of Gastrointestinal Symptoms) (Other)

结局指标

主要结局

Prevalence of documented alarm symptoms

时间窗: Completed and documented by the physician in the clinic note within 1 week of the initial clinic visit

Prevalence of documented alarm symptoms (blood in the stool, unintentional weight loss, hematochezia, hematemesis) in the clinic note as documented by physicians.

次要结局

  • Time to diagnosis of organic disease(Time to diagnosis of organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) within 6 months of the initial clinic visit)
  • Prevalence of diagnosed organic disease(Organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) diagnosed within 6 months of the initial clinic visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Almario

Staff Physician and Health Services Research Scientist

Cedars-Sinai Medical Center

研究点 (2)

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