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临床试验/NCT04254588
NCT04254588已完成不适用

Can Telemedicine Examinations of the Abdomen Safely Determine the Need for Abdominal Imaging?

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年2月10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
86
试验地点
1
主要终点
Requirement of imaging after abdominal examination

研究概览

简要总结

A study of patients with abdominal pain being seen by physicians at an academic emergency department and by physicians who are based remotely (telehealth).

Hypothesis: When a patient with abdominal pain is examined by a physician at the hospital versus a physician who is remote (i.e. not at the hospital), they will agree most of the time for the need of abdominal imaging for the patient within 12 hours of their examination.

详细描述

This will be a prospective, observational, blinded diagnostic concordance study of patients being seen for abdominal pain at an academic emergency department (ED) at Massachusetts General Hospital (MGH).

The study will consist of two phases. Both phases will have an on-call telemedicine physician who will assess the patient and answer the question about need for imaging.

The first phase mitigates technical issues with the telemedicine technology by using the high-resolution MGH TeleHealth Stroke Cart. This will allow telemedicine hardware that has been vetted in the high-acuity and high-reliability Acute Stroke Service and will minimize the impact of potential technical problems with iPads and wireless connectivity.

The second phase will substitute the Stroke Cart with an iPad to mimic the devices that the patients will likely be using from home in a direct-to-patient telehealth program.

Initially, we expected to enroll up to 72 subjects in 2 phases. Each phase would have needed 30 patients for significant results, and another 6 patients are estimated for patients that may become ineligible during the study visit (e.g., potential for contamination if the subject mentions the abdominal imaging plans of the in-person provider during the telemedicine examination). Phase 1 provided more information and changed our assumptions for Phase 2 sample size. We increased Phase 2 enrollment target to 60 subjects; we need 53 patients for significant results and will add 7 patients should they become ineligible during the study. Therefore, a total of 90 subjects in Phase 1 and 2 will be enrolled.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient presenting to the MGH Emergency Department with abdominal pain
  • English-speaking

排除标准

  • Known to be pregnant
  • Patients with altered mental status
  • Patients who are critically ill or unstable

结局指标

主要结局

Requirement of imaging after abdominal examination

时间窗: 12 hours

Questionnaire agreement (yes no) between the in-person and telehealth physicians for the requirement of imaging after abdominal examination.

次要结局

未报告次要终点

研究者

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

Emily Marie Hayden

Attending Physician and Director of Telemedicine, Department of Emergency Medicine

Massachusetts General Hospital

研究点 (1)

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