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临床试验/NCT02436057
NCT02436057已完成不适用

Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform

Cedars-Sinai Medical Center6 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
6
主要终点
Patient satisfaction

研究概览

简要总结

Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System (PROMIS). By the end of the grant period in July 2013, the project team had successfully developed and initially validated eight scales measuring the most common GI symptoms.

Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm which is delivered via My GI Health, an open--source Internet based patient-provider portal (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers, tablets or smart phones without the constraints of physical locale. This information is condensed into a GI PROMIS scores report and initial GI history that patients' providers can review prior to or concurrent with seeing the patient. The report, which can be incorporated into the electronic health record (EHR), helps busy clinicians to quickly understand the patient's complaints, document their symptoms and GI history, and leaves more time for conversation with the patient.

Beyond focusing their interaction, My GI Health also supports both the clinician and patient with an individualized "educational prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments also contained within the website. The prescription is initially created by the website based on each patient's unique GI PROMIS "fingerprint", and can be modified by the provider based on their interaction with the patient. The clinician and patient can also access the PROMIS-tailored education in the exam room to jointly review pertinent materials, including animations of normal and abnormal GI functions, further reinforcing the patients' educational experiences around the PROMIS symptoms.

The aim of this current study is to validate the use of GI PROMIS in clinical practice by conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel e--platform vs. usual care.

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.

结局指标

主要结局

Patient satisfaction

时间窗: CG-CAHPS completed within 2 months of their clinic visit

The Consumer Assessment of Health Providers \& Systems Clinician and Group Survey - Adult Visit Questionnaire 2.0 (CG-CAHPS) will be used to assess patient satisfaction.

次要结局

  • Patient Assessment of Physician Interpersonal Skills(DISQ completed within 2 months of their clinic visit)
  • Patient Assessment of Shared Decision Making(SDM-Q-9 completed within 2 months of their clinic visit)

研究者

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

Brennan Spiegel

Professor-in-Residence of Medicine and Public Health

Cedars-Sinai Medical Center

研究点 (6)

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