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临床试验/NCT01163474
NCT01163474已完成早期 1 期

Telemedicine in Cardiac Surgery: A Pilot Study

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年10月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)

研究概览

简要总结

Telemedicine has been widely used in managing patients with neurologic disorders or mental illness. Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications for the health and education of the patient or healthcare provider and for the purpose of improving patient care. According to our knowledge, it has not been used to manage cardiac patients who need postoperative care after discharge from hospitals.

The use of telemedicine has the potential to reduce the cost of unnecessary travel by assessing the patient's postoperative status prior to making decisions as to whether or not a face-to-face consultation is necessary.

In this pilot study we will compare the accuracy of surgeons' decisions during follow-up visits via video-teleconference (V-Visit) to surgeons' decisions during traditional face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask both patients and providers to complete short questionnaires after each V-Visit regarding their acceptability of using telemedicine for these post-operative follow-up visits.

Information collected as part of this pilot study will be used to design a future full randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative cardiac surgical patients.

详细描述

The specific aims are:

  1. To compare surgeons' decisions on patient disposition between V-visits and FTF-visits (gold standard).
  2. To assess the acceptability to patients and surgeons of using V-visits in the postoperative care of cardiac surgical patients;
  3. To assess the technical feasibility of using community-based outpatient clinics (CBOCs) for delivery of postoperative cardiac surgical care;
  4. To determine the recruitment rate for eligible subjects.

We plan to conduct this pilot study at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, along with satellite CBOC facilities in Lufkin and Conroe. Once the accuracy, acceptability, and feasibility of the use of video conferencing (VC) in the postoperative care for cardiac surgical patients are established, we will submit a full proposal to conduct a two-arm RCT in future.

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

  • Patients older than 18 years of age
  • Patients who have undergone one of the following cardiac surgical procedures:
  • Coronary artery bypass grafting (CABG) and/or Cardiac valvular operations

排除标准

  • Patients who have undergone aortic dissection/aneurysm operations
  • Patients who have been diagnosed with atrial fibrillation

研究组 & 干预措施

Arm 1 - All study participants

Experimental

Evaluate video clinic visit prior to Face-to-Face usual care visit

干预措施: Evaluate video clinic visit prior to Face-to-Face usual care visit (Other)

结局指标

主要结局

Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)

时间窗: 1 month

Using CVT software and desktop webcams on the VA private network, "Virtual" CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers' CVT decisions to the FTF decision.

次要结局

  • Acceptability(1 month)
  • Feasibility(1 month)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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